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

NCT ID: NCT03862495

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2024-03-03

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.

Conditions

Chlamydia Trachomatis Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Chlamydia Screening and Treatment

At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.

Group Type: EXPERIMENTAL

C. trachomatis and N. gonorrhoeae

Intervention Type: DIAGNOSTIC_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.

Azithromycin

Intervention Type: DRUG

Azithromycin 1g administered as a single oral dose

Partner notification and treatment

Intervention Type: OTHER

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

Control

This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.

Group Type: EXPERIMENTAL

C. trachomatis and N. gonorrhoeae

Intervention Type: DIAGNOSTIC_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.

Azithromycin

Intervention Type: DRUG

Azithromycin 1g administered as a single oral dose

Partner notification and treatment

Intervention Type: OTHER

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

Interventions

C. trachomatis and N. gonorrhoeae

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.

Intervention Type: DIAGNOSTIC_TEST

Azithromycin

Azithromycin 1g administered as a single oral dose

Intervention Type: DRUG

Partner notification and treatment

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

Intervention Type: OTHER

Other Intervention Names

Roche Cobas Z480; Zithromax, Zmax

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiming Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Dermatology Hospital of Southern Medical Hospital

Guangzhou, Guangdong, China

Nanhai Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-1168

Identifier Type: -

Identifier Source: org_study_id