An interventional study of Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert in Chlamydia Trachomatis Infection, Neonatal Infection and Preterm Birth, sponsored by University of Southern California. Completed at 2 sites in 2 countries. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by University of Southern California · Not applicable, Interventional, and Screening
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 500 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
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.
Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
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.
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
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
Time frame: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.
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.
Time frame: This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.
| Milestone | Testing and Treatment | Standard of Care |
|---|---|---|
| Started | 251 | 249 |
| Completed | 220 | 207 |
| Not completed | 31 | 42 |
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
| Participants | Testing and Treatment | Standard of Care |
|---|---|---|
| Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | 2 | 23 |
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.
| Participants | Testing and Treatment | Standard of Care |
|---|---|---|
| Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | 7 | 3 |
Collected over Through study completion, an average of 36 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testing and Treatment | 0/251 (0%) | 16/251 (6.4%) | 0/251 (0%) |
| Standard of Care | 1/249 (0.4%) | 15/249 (6%) | 0/249 (0%) |
| Event | Testing and Treatment | Standard of Care |
|---|---|---|
| MiscarriagePregnancy, puerperium and perinatal conditions | 11/251 | 9/249 |
| StillbirthPregnancy, puerperium and perinatal conditions | 5/251 | 6/249 |
| Age, Categorical(Participants) | Testing and Treatment | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 12 | 13 | 25 |
| Between 18 and 65 years | 239 | 236 | 475 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Testing and Treatment | Standard of Care | Total |
|---|---|---|---|
| Mean | 28 (16 to 42) | 28 (17 to 42) | 28 (16 to 42) |
| Sex: Female, Male(Participants) | Testing and Treatment | Standard of Care | Total |
|---|---|---|---|
| Female | 251 | 249 | 500 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Testing and Treatment | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 251 | 249 | 500 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Testing and Treatment | Standard of Care | Total |
|---|---|---|---|
| Botswana | 251 | 249 | 500 |
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Plan to share: No — No IPD will be shared with other researchers
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