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OpenTrials
Completed

NCT Number: NCT05465304

Effect of Azithromycin in Preventing 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

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Key information

Age range

18 year–32 year

Sex eligibility

Female

Study type

Observational

Primary location

Beni-Suef University teaching Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated

Primary outcomes

  1. Effect of Azithromycin in preventing premature labour

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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