Effect of Azithromycin in Preventing Premature Labour

Completed

• Conditions: Pregnant With Complication
• Interventions: Drug: Azithromycin

• Registration Number: NCT05465304
• Lead Sponsor: Beni-Suef University

Brief Summary

This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.

The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin

Detailed Description

A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.

The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.

. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-30
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Pregnant women with <34 weeks of gestation,
• Hospitalization for risk of preterm labour,
• Threat of preterm labour, or preterm labour itself.
• Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
• Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes

Exclusion Criteria

• Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required <37 weeks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin plus Clindamycin group	Azithromycin	the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.
Azithromycin group	Azithromycin	the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month

Primary Outcome Measures

Name	Time	Method
Effect of Azithromycin in preventing premature labour	6 monthes	Main outcome was the number of days between diagnosis and composite event, defined as delivery or rupture of membranes or 2nd intervention aimed at prolonging pregnancy (such as cerclage or tocolysis) or censure (maternal death or transfer). The three groups were compared regarding this number of days

Trial Locations

Locations (1)

Beni-Suef University teaching Hospital; 🇪🇬 Banī Suwayf, Beni-Suef, Egypt