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Completed

NCT Number: NCT05118984

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

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.

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Key information

Conditions

Meconium Stained Azithromycin Postpartum Endometritis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University, Cairo, Egypt

Loading trial locations.

About this study

Meconium stained amniotic fluid, a troublesome situation both for obstetrician and pediatrician, it is associated with high rates of caesarean section, perinatal morbidity and mortality. The rate of meconium-stained amniotic fluid varies from 12 to 20%.It is higher in underdeveloped countries.Our study design would be a prospective randomized trial. Consented, eligible pregnant women presenting during the first stage of labor at or more than 37 weeks of gestation with meconium stained amniotic fluid will be randomized to receive Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12hrs on empty stomach for 3 days)(Group 1).Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, color and consistency as Azithromycin capsule for 3 days).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multigravida pregnant women with meconium stained amniotic fluid encountered either by spontaneous/artificial amniotomy during the first stage of labor in the ward provided that the gestational age at delivery is 37 weeks of gestation or more.
  • Singleton living gestation
  • Cephalic presentation
  • Adequate pelvis
  • An informed written consent for the proposed study.

Exclusion criteria

  • Primigravids
  • Women with previous cesarean section
  • Multifetal gestation
  • Intrauterine fetal death
  • Malpresentations
  • Prematurity (<37 weeks )
  • Abnormally invasive placenta during the current pregnancy
  • Medical disorders with pregnancy
  • Contracted pelvis
  • Evidence of maternal infection
  • Allergy to azithromycin or other macrolides that is self-reported or documented in the medical record.

Treatment and study plan

Azithromycin capsule (Zithromax, Pfizer) (250 mg)

Drug

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.

Placebo

Drug

A treatment that has no active properties

Primary outcomes

  1. Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on occurrence of maternal fever, postpartum endometritis and skin (episiotomy/tear) infection.

    Time frame: within 1 week from delivery

    Mothers will be followed up during her stay in the postnatal ward regarding signs of infection (fever, maternal tachycardia, offensive vaginal discharge, uterine tenderness). Postpartum follow up visit 1 week after delivery will be conducted.

  2. Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on occurrence of neonatal fever , pneumonia and skin infection .

    Time frame: within 1 week from delivery

    Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever.

Secondary outcomes

  1. Fetal necessity for NICU admission and/or mechanical ventilation.

    Time frame: after delivery and within 1 week postartum

    Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF

  2. Occurrence of meconium aspiration

    Time frame: after delivery and within 1 week postpartum

    Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS.

  3. 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).

    Time frame: wwithin 1 week postpartum

    Mothers follow up for incidence of side effects related to Azithromycin

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison 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, a Double-blind, Placebo-controlled Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2021
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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