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| Name | Class |
|---|---|
| Botswana Harvard AIDS Institute Partnership | OTHER |
| University of California, San Diego | OTHER |
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To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).
In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing and treatment | Experimental | Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. |
|
| Standard of care | No Intervention | Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert | Other | Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms | This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms. | This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90032 | United States | ||
| DHMT Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39366745 | Derived | Mussa A, Wynn A, Ryan R, Babalola CM, Hansman E, Simon S, Bame B, Moshashane N, Masole M, Wilson ML, Klausner JD, Morroni C. Effect of antenatal Chlamydia trachomatis and Neisseria gonorrhoeae screening on postdelivery prevalence and vertical transmission in Gaborone, Botswana: findings from an exploratory study. Sex Transm Infect. 2025 Mar 24;101(2):81-87. doi: 10.1136/sextrans-2023-055965. | |
| 35255814 |
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No IPD will be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Testing and Treatment | Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert: Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert |
| 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 | Yes | No | No | Study Protocol | Sep 19, 2022 | Nov 13, 2024 |
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Clinic randomized trial evaluating the effectiveness of antenatal CT and NG screening and treatment compared to the standard of care (treatment based on signs and symptoms) on pregnancy and neonatal outcomes.
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| Gaborone |
| Botswana |
| Derived |
| Wynn A, Mussa A, Ryan R, Hansman E, Simon S, Bame B, Moreri-Ntshabele B, Ramogola-Masire D, Klausner JD, Morroni C. Evaluating the diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences in Gaborone, Botswana: protocol for the Maduo study. BMC Infect Dis. 2022 Mar 7;22(1):229. doi: 10.1186/s12879-022-07093-z. |
| FG001 | Standard of Care | Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Testing and Treatment | Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert: Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert |
| BG001 | Standard of Care | Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms | Posted | Count of Participants | Participants | This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery. |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms. | Posted | Count of Participants | Participants | This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery. |
|
Through study completion, an average of 36 weeks.
All adverse events are reported to the IRB and, if appropriate, to the Data and Safety Monitoring Board (DSMB), or other government agencies.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testing and Treatment | Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert: Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert | 0 | 251 | 16 | 251 | 0 | 251 |
| EG001 | Standard of Care | Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. | 1 | 249 | 15 | 249 | 0 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Defined as pregnancy loss before the 20th week of gestation wa identified through self-report by the participants, and through medical record abstraction. |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Defined as fetal death at or after 20 weeks gestation and prior to delivery, was identified through self-report by the participants, and medical record abstraction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey D. Klausner | USC | 415-876-8901 | jdklausner@med.usc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2022 | Jan 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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