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This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity
Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.
Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women with term prolonged>18h rupture of membrane | Active Comparator | women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery |
|
| women with preterm labor | Active Comparator | women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin Only Product | Drug | women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| endometritis rate | up to 6 weeks postpartum | |
| chorioamnionitis rate | during labor (up to delivery of the newborn) |
| Measure | Description | Time Frame |
|---|---|---|
| cord blood pH | immediately after delivery of the placenta | |
| maternal intrapartum fever | body temperature, | during labor (up to delivery of the newborn) |
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Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery
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Exclusion Criteria:
women 18 years or older with singleton pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Wolf, MD | Contact | 972-50-7887800 | mayaw@gmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galil Medical Center | Recruiting | Nahariya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17365450 | Background | Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644. | |
| 28742677 | Background | Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236. |
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women with prolonged premature rupture of membrane>18 h or women in preterm delivery will be randomized to receive one of two prophylactic antibiotic treatment
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| ampicillin plus gentamicin | Drug | women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin |
|
| NICU (neonatal intensive care unit) hospitalization length, | days | up to 3 month from delivery |
| rate of neonatal early onset sepsis | positive blood culture | up to one week from delivery |
| Rate of participants treated with antibiotics during the postpartum period | 6 week postpartum |
| maternal postpartum hospitalization length | up to 6 weeks post partum |
| Number of neonate with ventilation support | one week from delivery |
| Number of neonate treated with antibiotics | one week from delivery |
| 31783982 | Background | Kachikis A, Eckert LO, Walker C, Bardaji A, Varricchio F, Lipkind HS, Diouf K, Huang WT, Mataya R, Bittaye M, Cutland C, Boghossian NS, Mallett Moore T, McCall R, King J, Mundle S, Munoz FM, Rouse C, Gravett M, Katikaneni L, Ault K, Klein NP, Roberts DJ, Kochhar S, Chescheir N; Brighton Collaboration Chorioamnionitis Working Group. Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7610-7622. doi: 10.1016/j.vaccine.2019.05.030. No abstract available. |
| 11717646 | Background | Yoon BH, Romero R, Moon JB, Shim SS, Kim M, Kim G, Jun JK. Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001 Nov;185(5):1130-6. doi: 10.1067/mob.2001.117680. |
| 8765246 | Background | Soper DE, Mayhall CG, Froggatt JW. Characterization and control of intraamniotic infection in an urban teaching hospital. Am J Obstet Gynecol. 1996 Aug;175(2):304-9; discussion 309-10. doi: 10.1016/s0002-9378(96)70139-4. |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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