Effect Of Azithromycin in Women at Risk of Preterm Labour

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05971654
Study type	Interventional
Source	Beni-Suef University
Contact
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	July 30, 2023
Completion date	May 30, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.