search
Back to results

Effect Of Azithromycin in Women at Risk of Preterm Labour

Primary Purpose

Preterm Labor

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
azithromycin
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor focused on measuring preterm delivery, Azithromycin

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beni-suef university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Azithromycin

control

Arm Description

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

pregnant woman at risk of preterm delivery

Outcomes

Primary Outcome Measures

Gestational age at time of delivery
measured in week's days'number

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
July 25, 2023
Sponsor
Beni-Suef University
search

1. Study Identification

Unique Protocol Identification Number
NCT05971654
Brief Title
Effect Of Azithromycin in Women at Risk of Preterm Labour
Official Title
Effect Of Azithromycin On Pregnancy Prolongation In Women at Risk of Preterm Labour
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
preterm delivery, Azithromycin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
azithromycin.:500 mg PO once for 5 days every month
Arm Title
control
Arm Type
No Intervention
Arm Description
pregnant woman at risk of preterm delivery
Intervention Type
Drug
Intervention Name(s)
azithromycin
Other Intervention Name(s)
zisrocin
Intervention Description
azithromycin.:500 mg PO once for 5 days every month
Primary Outcome Measure Information:
Title
Gestational age at time of delivery
Description
measured in week's days'number
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beni-suef university Hospital
City
Banī Suwayf
State/Province
Beni Suef
ZIP/Postal Code
62521
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect Of Azithromycin in Women at Risk of Preterm Labour

We'll reach out to this number within 24 hrs