Effect Of Azithromycin in Women at Risk of Preterm Labour

NCT ID: NCT05971654

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2024-05-30

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

Conditions

Preterm Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Azithromycin

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

Group Type: EXPERIMENTAL

azithromycin

Intervention Type: DRUG

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

control

pregnant woman at risk of preterm delivery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

azithromycin

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

Intervention Type: DRUG

Other Intervention Names

zisrocin

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Countries

Egypt

Other Identifiers

Azithromycin preterm

Identifier Type: -

Identifier Source: org_study_id