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

NCT03862495 | Completed Results FDA Device

• 1 other identifier: 18-1168
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Chlamydia Trachomatis Infection

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

  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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

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

  1 month after the treatment

• Number of Participants Considered Cured at 3 Months After the Treatment

  3 months after the treatment

• Number of People Who Completed Follow-up

  through study completion, an average of 1 year

Study Arms (2)

Chlamydia Screening and Treatment

EXPERIMENTAL

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; Drug: Azithromycin; Other: Partner notification and treatment

Control

EXPERIMENTAL

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; Drug: Azithromycin; Other: Partner notification and treatment

Interventions

C. trachomatis and N. gonorrhoeae 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.

Also known as: Roche Cobas Z480

Chlamydia Screening and Treatment; Control

Azithromycin DRUG

Azithromycin 1g administered as a single oral dose

Also known as: Zithromax, Zmax

Chlamydia Screening and Treatment; Control

Partner notification and treatment OTHER

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

Chlamydia Screening and Treatment; Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
• comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Southern Medical University, China: collaborator

Study Sites (2)

Dermatology Hospital of Southern Medical Hospital

Guangzhou, Guangdong, China

Location

Nanhai Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Azithromycin; Contact Tracing; Therapeutics

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Epidemiologic Methods; Investigative Techniques; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice

Results Point of Contact

• Title: Deputy Chief Physician Li Changchang
• Organization: Skin Disease Hospital of Southern Medical University

lichch8@mail2.sysu.edu.cn

18585239166

Study Officials

• Weiming Tang, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 5, 2019
• Study Start: May 21, 2020
• Primary Completion: March 3, 2024
• Study Completion: March 3, 2024
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From December 2020 to May 2023
• 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.

Locations

CN (2)