NCT05465304

Effect of Azithromycin in Preventing Premature Labour

Effect of Azithromycin on Pregnancy Prolongation in Women at Risk for Premature Labour

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 18 Years – 32 Years
• Healthy volunteers: —

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.

Conditions

• Pregnant With Complication

Interventions

Type	Name	Description
DRUG	Azithromycin	The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-30
• First posted: 2022-07-19
• Last updated: 2023-05-17

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study