Trial Outcomes & Findings for Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences (NCT NCT04955717)

Last Updated: 2025-02-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

500 participants

Primary outcome timeframe

This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.

Results posted on

2025-02-03

Participant Flow

Unit of analysis: Clinic

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	251 4	249 3
Overall Study COMPLETED	220 4	207 3
Overall Study NOT COMPLETED	31 0	42 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testing and Treatment n=251 Participants 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	Standard of Care n=249 Participants 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.	Total n=500 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	239 Participants n=5 Participants	236 Participants n=7 Participants	475 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28 years n=5 Participants	28 years n=7 Participants	28 years n=5 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	249 Participants n=7 Participants	500 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	251 Participants n=5 Participants	249 Participants n=7 Participants	500 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Botswana	251 participants n=5 Participants	249 participants n=7 Participants	500 participants n=5 Participants

PRIMARY outcome

Timeframe: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.

Outcome measures

Outcome measures
Measure	Testing and Treatment n=206 Participants Participants in the intervention 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 participants 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	Standard of Care n=187 Participants 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.
Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery	2 Participants	23 Participants

SECONDARY outcome

Timeframe: This outcome will be assessed at the first postnatal care visit up to 12 weeks after 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.

Outcome measures

Outcome measures
Measure	Testing and Treatment n=208 Participants Participants in the intervention 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 participants 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	Standard of Care n=187 Participants 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.
Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.	7 Participants	3 Participants

Adverse Events

Testing and Treatment

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 15 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Testing and Treatment n=251 participants at risk 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	Standard of Care n=249 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Miscarriage	4.4% 11/251 • Number of events 11 • 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.	3.6% 9/249 • Number of events 9 • 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.
Pregnancy, puerperium and perinatal conditions Stillbirth	2.0% 5/251 • Number of events 5 • 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.	2.4% 6/249 • Number of events 6 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey D. Klausner

USC

Phone: 415-876-8901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place