Effect Of Azithromycin in Women at Risk of Preterm Labour

Preterm Labor Clinical Trial

Official title:

Effect Of Azithromycin On Pregnancy Prolongation In Women at Risk of Preterm Labour

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05971654
• Other study ID #: Azithromycin preterm
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 30, 2023
• Est. completion date: May 30, 2024

Study information

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

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

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

Locations

Country	Name	City	State
Egypt	Beni-suef university 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	Gestational age at time of delivery	measured in week's days'number	9 months