Effect Of Azithromycin in Women at Risk of Preterm Labour

Phase 2

Not yet recruiting

• Conditions: Preterm Labor
• Interventions: Drug: azithromycin

• Registration Number: NCT05971654
• Lead Sponsor: Beni-Suef University

Brief Summary

The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

Detailed Description

Study Design:

Comparative controlled study.

Study site :

The study will be conducted at the department of Obstetrics and Gynecology at Beni-Suef University Hospital.

Study period:

The study will be conducted from 15th September 2022 till reaching the target number.

Study Population 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 prophylactic azithromycin.:500 mg PO once for 5 days every month.

Sample size:

The sample size was determined using G\*Power Version 3.1.9.2 \[computer software\] (Franz Faul, Kiel, Germany),Power analysis for a chi-square test was conducted in G-POWER to determine a sufficient sample size using an alpha error of probability of 0.05, power of 0.95, a medium effect size (w = 0.3) and 1 degree of freedom. Based on the aforementioned assumptions, the desired sample size is 145. By calculating 25% drop out, so the least total sample size in both groups will be 200 patients (95 patients in each group).

Each patient will be subjected to:

Thorough history taking and examination. Investigations: Complete blood picture (CBC), bleeding profile , kidney function tests and liver function tests will be done.

Ultrasound: 2D Ultrasound assessing :

It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital, ultrasonography criteria: Ultrasound biometry of the fetus is now the gold standard for assessing fetal growth. The measurements most commonly used are the biparietal diameter, head circumference, abdominal circumference and femur length

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study Start: 2023-07-30
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2023-09-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

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

Inclusion Criteria

• 24 < Pregnancy <37 weeks of gestation.
• Threat or history of preterm labour.
• Preterm labour itself (Non established)

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Exclusion Criteria

• antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus B prophylaxis);
• PPROM; and fetal extraction required <37 weeks.
• Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ).
• Adverse perinatal outcome due to abdominal trauma.
• Structural fetal anomalies detected during anomaly scan.
• Allergy to Azithromycin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin	azithromycin	azithromycin.:500 mg PO once for 5 days every month

Primary Outcome Measures

Name	Time	Method
Gestational age at time of delivery	9 months	measured in week's days'number

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt