Effect of Azithromycin in Preventing Premature Labour

Pregnant With Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465304
• Other study ID #: REC-H-PhBSU-21022
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2022
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Pregnancy Complications
• Pregnant With Complication

Intervention

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

Locations

Country	Name	City	State
Egypt	Beni-Suef University teaching Hospital	Bani Suwayf	Beni-Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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