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| ID | Type | Description | Link |
|---|---|---|---|
| U24HD092094 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| University Teaching Hospital, Lusaka, Zambia | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.
The A-PLUS Trial is a randomized, placebo-controlled, parallel multicenter clinical trial. The study intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, with a comparison with a single intrapartum oral dose of an identical appearing placebo. For the A-PLUS randomized control trial (RCT), a total of 34,000 laboring women from eight research sites in sub-Saharan Africa, South Asia, and Latin America will be randomized with one-to-one ratio to intervention/placebo. In response to the global coronavirus pandemic, research sites will also collect data on COVID-19 signs/symptoms, diagnosis, and treatment in order to estimate the incidence of infection and evaluate the impact of the pandemic on the target population.
Prior to the initiation of the A-PLUS RCT, research sites will conduct an observational pilot study using the RCT's planned infrastructure in order to characterize the current practices at participating research facilities and optimize the identification of suspected infection for the RCT. The information obtained in the pilot study will be used to validate estimates of intrapartum deaths, maternal sepsis, and neonatal sepsis used in the sample size calculations for the RCT. Finally, the pilot study will allow the research sites to inventory and upgrade local capacity to conduct routine cultures during the RCT.
A maximum of 16,000 women, separate from the sample for the main trial, will be enrolled in the pilot, across all eight research sites, with no more than 2000 women enrolled at any individual site. Research sites will be eligible to transition to the RCT when a minimum of 600 participants have been enrolled in the pilot study with evidence of (a) high rates of follow-up; (2) acceptable data quality and completeness; and (3) there are no concerns about identification and reporting of infection.
Given the clinical benefits of intrapartum azithromycin so far reported in two trials and the likelihood that it may become the usual practice if the investigator's large RCT confirms the reported benefits, it is important to monitor antibiotic resistance to determine the safety of azithromycin prophylaxis. Therefore, the RCT will also include an ancillary study (referred to as the antimicrobial resistance (AMR) sub-study) to monitor antimicrobial resistance and maternal and newborn microbiome effects of the single dose of prophylactic azithromycin using the following methodology
For all mothers enrolled in the RCT and their infants:
a. Routine clinical monitoring at baseline and three post-partum time points (3 days, 7 days, and 42 days), with culture and sensitivity testing in cases of suspected bacterial infections;
Among a subset of 1000 randomly selected maternal-infant dyads:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The study intervention is a single 2 g dose of directly observed oral azithromycin. |
|
| Placebo | Placebo Comparator | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered as four 500 mg pills or tablets directly after randomization. By random allocation, participants will receive 2 g of oral azithromycin. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Death or Sepsis Within 6 Weeks (42 Days) Post-delivery in Intervention vs. Placebo Group. | Maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | Within 6 weeks (42 days) |
| Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group | Intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among stillbirths and neonates with 28-day status available born to women randomized. The study includes multiple births so there are more stillbirths and neonates than participants enrolled. | Within 4 weeks (28 days) post-delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Sepsis | Maternal sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | Within 42 days post-delivery |
| Maternal Death Due to Sepsis | Maternal death due to sepsis using the Global Network algorithm for cause of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Koso-Thomas, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICDDRB | Dhaka | 1212 | Bangladesh | |||
| Kinshasa School of Public Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | World Health Organization. (2015). WHO recommendations for the prevention and treatment of maternal peripartum infections. Retrieved August 22, 2018, from http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines | ||
| 25280870 | Background | Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30. | |
| 25842221 |
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Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH) system, a publicly accessible online archive, following publication of the primary paper.
No more than one year after publication of the primary paper. No end date.
Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH) system, a publicly accessible online archive. Investigators interested in data and access are required to submit their request through N-DASH, per the requirements of the DASH policy. This includes a brief description of the proposed use of the research data, a signed NICHD DASH Data Use Agreement, and IRB approval, exemption, or declaration that the research does not involve human subjects.
Participants were randomly assigned (1:1, stratified by site) to receive azithromycin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating center. Mother were randomized and the maternal participant and her baby or babies in the case of multiple pregnancies were enrolled.
Randomized, multi-country, double-masked, placebo-controlled trial of azithromycin (single 2g oral dose) initiated during labor, in women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin Intervention (Mothers) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 13, 2022 |
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| Kinshasa School of Public Health |
| OTHER |
| University of Colorado, Denver | OTHER |
| Institute of Nutrition of Central America and Panama | OTHER |
| University of Virginia | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Thomas Jefferson University | OTHER |
| Columbia University | OTHER |
| Aga Khan University | OTHER |
| Boston University | OTHER |
| Lata Medical Research Foundation, Nagpur | OTHER |
| Indiana University | OTHER |
| Moi Univeristy | OTHER |
| RTI International | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
| Jawaharlal Nehru Medical College | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Randomized, placebo-controlled, parallel multicenter clinical trial. Women in labor will be randomized with one-to-one ratio to intervention/placebo.
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Both the azithromycin and placebo will be procured from the same manufacturer. The packaging will be standardized across sites and will be labeled as: "Azithromycin 2 g or Placebo", with the expiration data and a unique identifier.
Clinical and research staff as well as the women will be masked to treatment status unless there is a serious adverse event potentially related to the treatment modality that requires unmasking for safety reasons. There will be one pharmacist at each site who will monitor randomization, drug supply, and safety. If concerns about randomization or participant safety are identified, the data coordinating center will authorize and instruct the study pharmacist to apply un-masking procedures.
| Placebo | Drug | Identical appearing placebo, administered as a single oral dose directly after randomization. |
|
| Within 42 days post-delivery |
| Chorioamnionitis | Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery. | Between date/time of randomization and date/time of delivery (up to 120 hours before delivery) |
| Endometritis | Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery. | Within 42 days post-delivery |
| Cesarean Wound Infection | Wound infection (Purulent infection of a Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); | Within 42 days post-delivery |
| Perineal Wound Infection | Wound infection (Purulent infection of a perineal wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); | Within 42 days post-delivery |
| Other Infections | Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage). Other bacterial infection. | Within 42 days post-delivery |
| Use of Subsequent Maternal Antibiotic Therapy | Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason. | After randomization to 42 days post-delivery. Randomization occurs between labor onset and delivery (0 to 120 hours before delivery). 42 participants were randomized >120 hours before delivery due to false labor. |
| Maternal Initial Hospital Length of Stay | Time from drug administration until initial discharge after delivery (time may vary by site). | Time from drug administration (which occurs between onset of labor and delivery) and discharge from delivery hospital (0 to 45 days) |
| Maternal Readmissions | Maternal readmissions after delivery discharge and within 42 days of delivery | After delivery discharge and within 42 days post-delivery |
| Maternal Admission to Special Care Units | Maternal admission to special care units | Within 42 days post-delivery (reported during study) |
| Maternal Unscheduled Visit for Care | Maternal unscheduled visit for care | Within 42 days post-delivery (reported during study) |
| Maternal GI Symptoms | Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects. | Within 42 days post-delivery (reported during study) |
| Neonatal Sepsis | Neonatal sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 28 days post-delivery |
| Neonatal Death Due to Sepsis | Neonatal death due to sepsis using the Global Network algorithm for causes of death. This outcome is measured among neonates with 28-day status available born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 28 days post-delivery |
| Other Neonatal Infections | Other neonatal infections (e.g. eye infection, skin infection). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 28 days post-delivery |
| Neonatal Initial Hospital Length of Stay | Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Time from delivery to discharge from delivery hospital (0 to 62 days) |
| Neonatal Readmissions | Neonatal readmissions to facility after delivery discharge and within 42 days of delivery. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | After delivery discharge and within 42 days of delivery |
| Neonatal Admission to Special Care Units | Neonatal admission to special care units. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 42 days post-delivery (reported during study) |
| Neonatal Unscheduled Visit for Care | Neonatal unscheduled visit for care. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 42 days post-delivery (reported during study) |
| Pyloric Stenosis Within 42 Days of Delivery | Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Within 42 days post-delivery |
| Kinshasa |
| Democratic Republic of the Congo |
| Institute for Nutrition of Central America and Panama (INCAP) | Guatemala City | 01011 | Guatemala |
| Jawaharlal Nehru Medical College | Belagām | 590 010 | India |
| Lata Medical Research Foundation | Nagpur | India |
| Moi University School of Medicine | Eldoret | 30100 | Kenya |
| The Aga Khan University | Karachi | 74800 | Pakistan |
| University Teaching Hospital | Lusaka | Zambia |
| Background |
| African Neonatal Sepsis Trial (AFRINEST) group; Tshefu A, Lokangaka A, Ngaima S, Engmann C, Esamai F, Gisore P, Ayede AI, Falade AG, Adejuyigbe EA, Anyabolu CH, Wammanda RD, Ejembi CL, Ogala WN, Gram L, Cousens S. Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet. 2015 May 2;385(9979):1767-1776. doi: 10.1016/S0140-6736(14)62284-4. Epub 2015 Apr 1. |
| 25841891 | Background | Baqui AH, Saha SK, Ahmed AS, Shahidullah M, Quasem I, Roth DE, Samsuzzaman AK, Ahmed W, Tabib SM, Mitra DK, Begum N, Islam M, Mahmud A, Rahman MH, Moin MI, Mullany LC, Cousens S, El Arifeen S, Wall S, Brandes N, Santosham M, Black RE; Projahnmo Study Group in Bangladesh. Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet Glob Health. 2015 May;3(5):e279-87. doi: 10.1016/S2214-109X(14)70347-X. Epub 2015 Apr 1. |
| 27988146 | Background | Mir F, Nisar I, Tikmani SS, Baloch B, Shakoor S, Jehan F, Ahmed I, Cousens S, Zaidi AK. Simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplified Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial. Lancet Glob Health. 2017 Feb;5(2):e177-e185. doi: 10.1016/S2214-109X(16)30335-7. Epub 2016 Dec 15. |
| 23945571 | Background | Zaidi AK, Tikmani SS, Sultana S, Baloch B, Kazi M, Rehman H, Karimi K, Jehan F, Ahmed I, Cousens S. Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial. Pediatr Infect Dis J. 2013 Sep;32 Suppl 1(Suppl 1 Innovative Treatment Regimens for Severe Infections in Young Infants):S19-25. doi: 10.1097/INF.0b013e31829ff7aa. |
| 6990333 | Background | Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045. |
| Background | World Health Organization. (2015). WHO Statement on Caesarean Section Rates. Retrieved August 22, 2018, from http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/cs-statement/en/ |
| 25479008 | Background | Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2. |
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| 25402227 | Background | Gyte GM, Dou L, Vazquez JC. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2014 Nov 17;2014(11):CD008726. doi: 10.1002/14651858.CD008726.pub2. |
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| 27682034 | Background | Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044. |
| 28130432 | Background | Oluwalana C, Camara B, Bottomley C, Goodier S, Bojang A, Kampmann B, Ceesay S, D'Alessandro U, Roca A. Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial. Pediatrics. 2017 Feb;139(2):e20162281. doi: 10.1542/peds.2016-2281. |
| Background | World Health Organization. (2017). Statement on maternal sepsis. Retrieved Ausust 22, 2018, from http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/maternalsepsis-statement/en/ |
| 28658587 | Background | Reinhart K, Daniels R, Kissoon N, Machado FR, Schachter RD, Finfer S. Recognizing Sepsis as a Global Health Priority - A WHO Resolution. N Engl J Med. 2017 Aug 3;377(5):414-417. doi: 10.1056/NEJMp1707170. Epub 2017 Jun 28. No abstract available. |
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| 28468653 | Background | Hoffman MK, Goudar SS, Kodkany BS, Goco N, Koso-Thomas M, Miodovnik M, McClure EM, Wallace DD, Hemingway-Foday JJ, Tshefu A, Lokangaka A, Bose CL, Chomba E, Mwenechanya M, Carlo WA, Garces A, Krebs NF, Hambidge KM, Saleem S, Goldenberg RL, Patel A, Hibberd PL, Esamai F, Liechty EA, Silver R, Derman RJ. A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. BMC Pregnancy Childbirth. 2017 May 3;17(1):135. doi: 10.1186/s12884-017-1312-x. |
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| 29382352 | Background | Bonet M, Souza JP, Abalos E, Fawole B, Knight M, Kouanda S, Lumbiganon P, Nabhan A, Nadisauskiene R, Brizuela V, Metin Gulmezoglu A. The global maternal sepsis study and awareness campaign (GLOSS): study protocol. Reprod Health. 2018 Jan 30;15(1):16. doi: 10.1186/s12978-017-0437-8. |
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| 28670748 | Background | Bowyer L, Robinson HL, Barrett H, Crozier TM, Giles M, Idel I, Lowe S, Lust K, Marnoch CA, Morton MR, Said J, Wong M, Makris A. SOMANZ guidelines for the investigation and management sepsis in pregnancy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):540-551. doi: 10.1111/ajo.12646. Epub 2017 Jul 3. |
| 42133947 | Derived | Ramani M, Carlo WA, Mwenechanya M, Chomba E, Goudar SS, Derman RJ, Metgud MC, Kavi A, Bauserman M, Patterson J, Tshefu AK, Lokangaka AL, Krebs NF, Mazariegos M, Barrientos D, Patel AB, Hibberd PL, Bhargav S, Andelkar A, Saleem S, Goldenberg RL, Tikmani SS, Yasmin H, Babineau DC, Hemingway-Foday JJ, Trotta M, Rasco C, McClure EM, Gustafson KE; ABC Study Group. Neurodevelopmental Pediatric Follow-Up After the Azithromycin Prevention in Labor Use Study. Obstet Gynecol. 2026 May 14. doi: 10.1097/AOG.0000000000006301. Online ahead of print. |
| 41527950 | Derived | Sidze L, Moore JL, Carlo WA, Mwenechanya M, Chomba E, Hemingway-Foday JJ, Kavi A, Metgud MC, Goudar SS, Derman R, Lokangaka AL, Tshefu AK, Bauserman MS, Bose CL, Shivkumar P, Waikar M, Patel AB, Hibberd PL, Nyongesa P, Esamai F, Ekhaguere OA, Bucher SL, Jessani S, Tikmani SS, Saleem S, Goldenberg RL, Billah SM, Lennox R, Haque R, Petri WA, Figueroa L, Mazariegos M, Krebs NF, Nolen TL, Koso-Thomas M, McClure EM, Tita ATN; A-PLUS Trial Group. Intrapartum oral azithromycin for maternal infection prophylaxis and the risk of postpartum hemorrhage: A secondary analysis of the A-PLUS trial. Int J Gynaecol Obstet. 2026 Jun;173(3):1562-1568. doi: 10.1002/ijgo.70777. Epub 2026 Jan 13. |
| 40155106 | Derived | Carlo WA, Tita ATN, Moore JL, Mwenechanya M, Chomba E, Hemingway-Foday JJ, Kavi A, Metgud MC, Goudar SS, Derman RJ, Lokangaka A, Tshefu A, Bauserman M, Patterson JK, Shivkumar P, Waikar M, Patel A, Hibberd PL, Nyongesa P, Esamai F, Ekhaguere OA, Bucher S, Jessani S, Tikmani SS, Saleem S, Goldenberg RL, Billah SM, Lennox R, Haque R, Petri W, Mazariegos M, Krebs NF, Babineau DC, McClure EM, Koso-Thomas M; A-PLUS Trial Group. Effectiveness of intrapartum azithromycin to prevent infections in planned vaginal births in low-income and middle-income countries: a post-hoc analysis of data from a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2025 Apr;13(4):e689-e697. doi: 10.1016/S2214-109X(24)00562-X. |
| 40155105 | Derived | Patterson JK, Neuwahl S, Kirsch S, Moore JL, Tita ATN, Carlo WA, Lokangaka A, Tshefu A, Mwenechanya M, Chomba E, Kavi A, Metgud MC, Goudar SS, Derman RJ, Shivkumar P, Waikar M, Patel A, Hibberd PL, Nyongesa P, Esamai F, Ekhaguere OA, Bucher S, Jessani S, Tikmani SS, Saleem S, Wylie BJ, Goldenberg RL, Billah SM, Lennox R, Haque R, Petri WA, Mazariegos M, Krebs NF, Hemingway-Foday JJ, Babineau D, Koso-Thomas M, McClure EM, Bauserman M. Cost-effectiveness of intrapartum azithromycin to prevent maternal infection, sepsis, or death in low-income and middle-income countries: a modelling analysis of data from a randomised, multicentre, placebo-controlled trial. Lancet Glob Health. 2025 Apr;13(4):e679-e688. doi: 10.1016/S2214-109X(24)00517-5. |
| 37648383 | Derived | Hemingway-Foday J, Tita A, Chomba E, Mwenechanya M, Mweemba T, Nolen T, Lokangaka A, Tshefu Kitoto A, Lomendje G, Hibberd PL, Patel A, Das PK, Kurhe K, Goudar SS, Kavi A, Metgud M, Saleem S, Tikmani SS, Esamai F, Nyongesa P, Sagwe A, Figueroa L, Mazariegos M, Billah SM, Haque R, Shahjahan Siraj M, Goldenberg RL, Bauserman M, Bose C, Liechty EA, Ekhaguere OA, Krebs NF, Derman R, Petri WA, Koso-Thomas M, McClure E, Carlo WA. Prevention of maternal and neonatal death/infections with a single oral dose of azithromycin in women in labour in low-income and middle-income countries (A-PLUS): a study protocol for a multinational, randomised placebo-controlled clinical trial. BMJ Open. 2023 Aug 30;13(8):e068487. doi: 10.1136/bmjopen-2022-068487. |
| 36757318 | Derived | Tita ATN, Carlo WA, McClure EM, Mwenechanya M, Chomba E, Hemingway-Foday JJ, Kavi A, Metgud MC, Goudar SS, Derman R, Lokangaka A, Tshefu A, Bauserman M, Bose C, Shivkumar P, Waikar M, Patel A, Hibberd PL, Nyongesa P, Esamai F, Ekhaguere OA, Bucher S, Jessani S, Tikmani SS, Saleem S, Goldenberg RL, Billah SM, Lennox R, Haque R, Petri W, Figueroa L, Mazariegos M, Krebs NF, Moore JL, Nolen TL, Koso-Thomas M; A-PLUS Trial Group. Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth. N Engl J Med. 2023 Mar 30;388(13):1161-1170. doi: 10.1056/NEJMoa2212111. Epub 2023 Feb 9. |
| FG001 | Azithromycin Intervention (Neonates) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. |
| FG002 | Placebo (Mothers) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. |
| FG003 | Placebo (Neonates) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. |
| Treated |
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| Included in Intention to Treat (ITT) Analysis |
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| COMPLETED |
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| NOT COMPLETED |
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Women who were eligible according to the intention-to-treat (ITT) criteria and included in the ITT analysis. Includes baseline data for neonates of randomized maternal participants. Baseline data was not collected for the 115 stillbirths. The number of neonates is larger than the number of maternal participants randomized due to multiple births.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin Intervention (Mothers) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. |
| BG001 | Azithromycin Intervention (Neonates) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. |
| BG002 | Placebo (Mothers) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. |
| BG003 | Placebo (Neonates) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Maternal age at enrollment (years) | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Median | Inter-Quartile Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital status | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Maternal education | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Primiparous | Primiparous indicates a parity=0. Parity is defined as the number of pregnancies reaching 20 weeks and 0 days of gestation or beyond, regardless of the number of fetuses or outcomes. In cases of multiple pregnancies, parity is only increased with birth of the last fetus. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Multiple birth | Multiple birth is the delivery of more than one offspring in a single birth event. For example, twin and triplet deliveries are considered multiple births. | Count of Participants | Participants |
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| Any maternal infection during pregnancy | Maternal infections during pregnancy include group B strep, pneumonia, pyelonephritis, rubella, chlamydia, herpes, syphilis, gonorrhea, HIV, hepatitis B, malaria, urinary tract infection or other infection. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Any maternal condition during pregnancy | Maternal conditions during pregnancy include diabetes, chronic hypertension, hypertensive disorders of pregnancy or other condition. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Gestational age < 37 weeks | Count of Participants | Participants |
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| Type of labor onset | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| High risk for sepsis before randomization | High risk for sepsis is defined as women who experience prolonged labor (time from labor to randomization >= 18 hours) or prolonged membrane rupture (time from rupture of membranes to randomization >=8 hours). This measure applies to mothers randomized and does not apply to neonates/stillbirths. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Prolonged labor >= 18 hours before randomization | Prolonged labor occurs when randomization is 18 or more hours after the onset of labor. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Prolonged rupture of membranes >= 8 hours before randomization | Prolonged rupture of membranes occurs when randomization is 8 or more hours after rupture of membranes. | This measure applies to mothers randomized and does not apply to neonates/stillbirths. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Death or Sepsis Within 6 Weeks (42 Days) Post-delivery in Intervention vs. Placebo Group. | Maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | Intention to treat (ITT) | Posted | Count of Participants | Participants | Within 6 weeks (42 days) |
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| Primary | Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group | Intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among stillbirths and neonates with 28-day status available born to women randomized. The study includes multiple births so there are more stillbirths and neonates than participants enrolled. | Intention to treat (ITT) | Posted | Count of Participants | Participants | Within 4 weeks (28 days) post-delivery |
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| Secondary | Maternal Sepsis | Maternal sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Maternal sepsis required a diagnosis of sepsis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Maternal Death Due to Sepsis | Maternal death due to sepsis using the Global Network algorithm for cause of death | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Maternal death due to sepsis required maternal status at 42-days to be included in the denominator. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Chorioamnionitis | Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery. | Intention to treat (ITT) | Posted | Count of Participants | Participants | Between date/time of randomization and date/time of delivery (up to 120 hours before delivery) |
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| Secondary | Endometritis | Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery. | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Endometritis required a diagnosis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Cesarean Wound Infection | Wound infection (Purulent infection of a Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); | Intention to treat (ITT). This outcome variable is analyzed for the subgroup of women with a cesarean delivery. Numbers differ from the participant flow ITT population due to this subgroup analysis and missing data specific to this secondary outcome. Cesarean wound infection required a diagnosis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Perineal Wound Infection | Wound infection (Purulent infection of a perineal wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); | Intention to treat (ITT). This outcome variable analyzed for the subgroup of women with a vaginal delivery. Numbers differ from the participant flow ITT population due to this subgroup analysis and missing data specific to this secondary outcome. Perineal wound infection required a diagnosis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Other Infections | Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage). Other bacterial infection. | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Other infections required a diagnosis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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| Secondary | Use of Subsequent Maternal Antibiotic Therapy | Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason. | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Use of subsequent maternal antibiotic therapy required a yes response or a no response on follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | After randomization to 42 days post-delivery. Randomization occurs between labor onset and delivery (0 to 120 hours before delivery). 42 participants were randomized >120 hours before delivery due to false labor. |
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| Secondary | Maternal Initial Hospital Length of Stay | Time from drug administration until initial discharge after delivery (time may vary by site). | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Time from drug administration until initial discharge after delivery required non-missing date and time variables for discharge after delivery. | Posted | Mean | Standard Deviation | days | Time from drug administration (which occurs between onset of labor and delivery) and discharge from delivery hospital (0 to 45 days) |
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| Secondary | Maternal Readmissions | Maternal readmissions after delivery discharge and within 42 days of delivery | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Maternal readmissions required non-missing date of delivery discharge and a readmission or no indication of a readmission and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | After delivery discharge and within 42 days post-delivery |
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| Secondary | Maternal Admission to Special Care Units | Maternal admission to special care units | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Maternal admission to special care units required a yes response or a no response on follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery (reported during study) |
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| Secondary | Maternal Unscheduled Visit for Care | Maternal unscheduled visit for care | Intention to treat (ITT). Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Maternal unscheduled visit for care required a visit for unscheduled care or a no visit reported on follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery (reported during study) |
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| Secondary | Maternal GI Symptoms | Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects. | Safety population. This is the Treated row of the participant flow. | Posted | Count of Participants | Participants | Within 42 days post-delivery (reported during study) |
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| Secondary | Neonatal Sepsis | Neonatal sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Neonatal sepsis is defined among live births so excludes stillbirths. Neonatal sepsis required a diagnosis of sepsis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 28 days post-delivery |
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| Secondary | Neonatal Death Due to Sepsis | Neonatal death due to sepsis using the Global Network algorithm for causes of death. This outcome is measured among neonates with 28-day status available born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Neonatal death due to sepsis is defined among live births so excludes stillbirths. Neonatal death due to sepsis required status at 28 days. | Posted | Count of Participants | Participants | Within 28 days post-delivery |
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| Secondary | Other Neonatal Infections | Other neonatal infections (e.g. eye infection, skin infection). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Other neonatal infections is defined among live births so excludes stillbirths. Other neonatal infections required a diagnosis according to the study algorithm or no diagnosis and follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 28 days post-delivery |
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| Secondary | Neonatal Initial Hospital Length of Stay | Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Neonatal initial hospital length of stay is defined among live births so excludes stillbirths. Neonatal initial hospital length of stay required non-missing date and time of hospital discharge. | Posted | Mean | Standard Deviation | days | Time from delivery to discharge from delivery hospital (0 to 62 days) |
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| Secondary | Neonatal Readmissions | Neonatal readmissions to facility after delivery discharge and within 42 days of delivery. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) | Posted | Count of Participants | Participants | After delivery discharge and within 42 days of delivery |
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| Secondary | Neonatal Admission to Special Care Units | Neonatal admission to special care units. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Neonatal admission to special care units is defined among live births so excludes stillbirths. Neonatal admission to special care units required a yes response or a no response on follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery (reported during study) |
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| Secondary | Neonatal Unscheduled Visit for Care | Neonatal unscheduled visit for care. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Intention to treat (ITT) for live births. Numbers differ from the participant flow ITT population due to missing data specific to this secondary outcome. Neonatal unscheduled visit for care is defined among live births so excludes stillbirths. Neonatal unscheduled visit for care required a reported unplanned care visit or no unplanned care reported on follow-up data on/beyond 7 days. | Posted | Count of Participants | Participants | Within 42 days post-delivery (reported during study) |
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| Secondary | Pyloric Stenosis Within 42 Days of Delivery | Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled. | Safety population for live births. Numbers differ from Treated in the participant flow because they are live births among treated mothers. | Posted | Count of Participants | Participants | Within 42 days post-delivery |
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Adverse events were monitored continuously throughout the study from time of randomization (between onset of labor and delivery) through 6-weeks post delivery.
Surveillance of maternal side effects potentially associated with azithromycin was conducted during labor and postpartum. For infants, findings suggestive of pyloric stenosis were assessed during the follow up visits. Maternal and neonatal surveillance included assessment of unintended medical visits and death. Potential side effects with azithromycin use were monitored and reported as a serious adverse event. Adverse events are reported among the Safety population (Treated).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin Intervention (Mothers) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. | 12 | 14,589 | 3 | 14,589 | 1,022 | 14,589 |
| EG001 | Azithromycin Intervention (Neonates) | The study intervention is a single 2 g dose of directly observed oral azithromycin. Azithromycin: The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered to maternal participants as four 500 mg pills or tablets directly after randomization which occurs between the onset of labor and delivery. By random allocation, participants will receive 2 g of oral azithromycin. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. | 291 | 14,686 | 11 | 14,686 | 8 | 14,686 |
| EG002 | Placebo (Mothers) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. | 11 | 14,687 | 3 | 14,687 | 1,110 | 14,687 |
| EG003 | Placebo (Neonates) | By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization. Placebo: Identical appearing placebo, administered to maternal participants as a single oral dose directly after randomization, which occurs between the onset of labor and delivery. Stillbirths and live births of maternal participants randomized are considered enrolled to the arm which their mother was randomized. | 286 | 14,781 | 8 | 14,781 | 3 | 14,781 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
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| Other maternal serious adverse event | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This event applies to neonates only (stillbirth or live birth) and not mothers. |
| |
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This event applies to neonates only (stillbirth or live birth) and not mothers. |
| |
| Other neonatal serious adverse event | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This event applies to neonates only (stillbirth or live birth) and not mothers. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomited within 15 minutes after study drug administration | Gastrointestinal disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Feeling faint or dizzy | Cardiac disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Diarrhea/loose stools | Gastrointestinal disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Severe abdominal or uterine pain | General disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Foul-smelling vaginal discharge | General disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Severe vaginal pain | General disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| GI symptoms and other reported side effects | Gastrointestinal disorders | Systematic Assessment | This event applies to mothers only and not neonates (stillbirth or live birth). |
| |
| Pyloric stenosis | Gastrointestinal disorders | Systematic Assessment | This event applies to neonates (stillbirth or live birth) and not mothers. |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth McClure | RTI International | 919-316-3773 | mcclure@rti.org |
| Jul 17, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D063130 | Maternal Death |
| D000071074 | Neonatal Sepsis |
| D066087 | Perinatal Death |
| D011645 | Puerperal Infection |
| D011251 | Pregnancy Complications, Infectious |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
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| Congo, The Democratic Republic of the |
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