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Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes

NCT05118984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2021-11-12

No results posted yet for this study

Summary

Meconium stained amniotic fluid increases the risk of maternal complications (e.g., dystocia, operative delivery, and postpartum endometritis) and neonatal complications (e.g., sepsis, admission to the neonatal intensive care unit \[NICU\], and meconium aspiration syndrome). The goal of the study is to compare between Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on maternal and neonatal outcomes.

Conditions

  • Meconium Stained
  • Azithromycin
  • Postpartum Endometritis

Interventions

DRUG

Azithromycin capsule (Zithromax, Pfizer) (250 mg)

Azithromycin, a second generation macrolide, broad-spectrum antibacterial that stops bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose. .Azithromycin has been beneficial in the treatment of influenza and Middle East respiratory syndrome coronavirus (MERS-CoV) and recently has shown to be effective against severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) when used in combination with hydroxychloroquine or chloroquine.

DRUG

Placebo

A treatment that has no active properties

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Gamal GamalEldin Youssef, PHD · Cairo University

  • Eman Aly Hussein Aly, PHD · Cairo University

  • Ahmed Samir Rashwan, PHD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-05-31
Completion
2021-10-04

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118984 on ClinicalTrials.gov