CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Azithromycin +2 moredrug
Likely dose
Azithromycin 1g as a single oral doseAI-extracted
Key inclusion· 3
  • Pregnant women presenting on their first visit to the hospital
  • Age 18 years or older
  • Willing to participate and provide informed consent
Key exclusion· 3
  • Systemic or topical vaginal antibiotic use within 2 weeks prior to first perinatal visit
  • Comorbidities known to be related to adverse pregnancy outcomes, such as diabetes or hypertension
  • Diagnosed adverse pregnancy outcomes at recruitment, e.g., stillbirth

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03862495
NCT03862495N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Mar 5, 2019·Updated Sep 5, 2024

In Brief

A clinical study evaluating C. trachomatis and N. gonorrhoeae, Azithromycin, and 1 other intervention for Chlamydia Trachomatis Infection. Completed, enrolled 200 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartMay 21, 2020
Primary CompletionMar 3, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.3 years ago

Interventions

C. trachomatis and N. gonorrhoeaeother

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