Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

University of North Carolina, Chapel Hill200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Chlamydia Trachomatis Infection

Interventions

C. trachomatis and N. gonorrhoeaeDIAGNOSTIC_TEST

In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.

AzithromycinDRUG

Azithromycin 1g administered as a single oral dose

Partner notification and treatmentOTHER

Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Dermatology Hospital of Southern Medical Hospital

Guangzhou, Guangdong, China

Nanhai Hospital of Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Response Rate at Recruitment

Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment

Time frame: at the time of enrollment

Compliance to Receive CT or NG Treatment

Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results

Time frame: Within 1 week after the notification of positive test results

Number of Participants Considered as Cured After Treatment

Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment

Time frame: 1 or 3 months after the treatment

Number of Participants With Adverse Pregnancy Outcomes

Number of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (\<2500g), smaller than gestational age, preterm birth (\<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Number of Participants Considered as Cured at 1 Month After the Treatment

Number of women who get tested for CT and NG 1 month after the treatment divided by the number of women who receive CT or NG treatment.

Data from ClinicalTrials.gov

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