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

August 8, 2023 updated by: University of North Carolina, Chapel Hill

Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Dermatology Hospital of Southern Medical Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanhai Hospital of Southern Medical University
        • Contact:
          • Tao Liu
          • Phone Number: +86-18927588462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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.
Other Names:
  • Roche Cobas Z480
Drug: Azithromycin
Azithromycin 1g administered as a single oral dose
Other Names:
  • Zithromax, Zmax
Other: Partner notification and treatment
Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
Experimental: 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.
Diagnostic test: 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.
Other Names:
  • Roche Cobas Z480
Drug: Azithromycin
Azithromycin 1g administered as a single oral dose
Other Names:
  • Zithromax, Zmax
Other: Partner notification and treatment
Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate at recruitment
Time Frame: at the time of enrollment
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
at the time of enrollment
Compliance to receive CT or NG treatment
Time Frame: Within 1 week after the notification of positive test results
Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results
Within 1 week after the notification of positive test results
Rate of cure after treatment
Time Frame: 1 or 3 months after the 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
1 or 3 months after the treatment
Incidence of adverse pregnancy outcomes
Time Frame: through study completion, an average of 1 year
Frequency of any adverse pregnancy outcomes, including stillbirth, fetal death, infant death, miscarriage, preeclampsia, smaller than gestational age, preterm birth, birth defect, and premature rupture of membrane in both groups through study completion
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test for cure rate at 1 month after the treatment
Time Frame: 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.
1 month after the treatment
Test for cure rate at 3 months after the treatment
Time Frame: 3 months after the treatment
Number of women who get tested for CT and NG 3 months after the treatment divided by the number of women who re-tested CT or NG positive at 1 month after the treatment
3 months after the treatment
Follow-up rate
Time Frame: through study completion, an average of 1 year
Number of women who are followed-up by the end of pregnancy or in the event of adverse pregnancy outcomes divided the number of women who are enrolled at the recruitment.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Southern Medical University, China

Investigators

  • Principal Investigator: Weiming Tang, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

From December 2020 to May 2023

IPD Sharing Access Criteria

Investigator who proposes to use the data should have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chlamydia Trachomatis Infection

Clinical Trials on C. trachomatis and N. gonorrhoeae

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe