Effect of Azithromycin in Preventing Premature Labour

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

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

Study Overview

• Status: Completed
• Conditions: Pregnant With Complication
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Beni-Suef
    • Banī Suwayf, Beni-Suef, Egypt, 62511
      • Beni-Suef University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Randomized Controlled prospective study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; 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.
Azithromycin group; 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	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
Azithromycin plus Clindamycin group; the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Azithromycin in preventing premature labour	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	6 monthes

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Raghda R.S Hussein, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Obstetric Labor Complications; Pregnancy Complications; Obstetric Labor, Premature; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: REC-H-PhBSU-21022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pregnant women with risk for pre mature labour will adiminster azithromycin as monotherapy or polytherapy with clindamycin vaginal cream ,The efficacy of Azithromycin in preventing premature mature labour will be assessed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No