Clinical trial NCT03862495: Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Official title: Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2019-03-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes.

Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.

Detailed description: Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.

Qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.

Eligibility criteria: Inclusion Criteria:

1. pregnant women on their first visit to the hospital (regardless of gestational age);
2. aged 18 or above;
3. agree to participate and sign an informed consent.

Exclusion Criteria:

1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
3. diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.

Primary outcomes:
measure: Response Rate at Recruitment
timeFrame: at the time of enrollment
measure: Compliance to Receive CT or NG Treatment
timeFrame: Within 1 week after the notification of positive test results
measure: Number of Participants Considered as Cured After Treatment
timeFrame: 1 or 3 months after the treatment
measure: Number of Participants With Adverse Pregnancy Outcomes
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Participants Considered as Cured at 1 Month After the Treatment
timeFrame: 1 month after the treatment
measure: Number of Participants Considered Cured at 3 Months After the Treatment
timeFrame: 3 months after the treatment
measure: Number of People Who Completed Follow-up
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanhai Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Weiming Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: