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

Chlamydia Trachomatis Infection Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862495
• Other study ID #: 18-1168
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: October 2023

Study information

• Verified date: February 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Juan Nie, MPH
• Phone: 13802994274
• Email: niejuan[@]seshglobal.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection

Intervention

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.

Drug:
• Azithromycin
Azithromycin 1g administered as a single oral dose

Other:
• Partner notification and treatment
Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses

Locations

Country	Name	City	State
China	Dermatology Hospital of Southern Medical Hospital	Guangzhou	Guangdong
China	Nanhai Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at the time of enrollment
Primary	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	Within 1 week after the notification of positive test results
Primary	Rate of cure 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	1 or 3 months after the treatment
Primary	Incidence of adverse pregnancy outcomes	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	Test for cure rate 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.	1 month after the treatment
Secondary	Test for cure rate at 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
Secondary	Follow-up rate	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