Overview

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

Status:
Completed
Trial end date:
2021-10-04
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cairo University
Treatments:
Azithromycin
Criteria
Inclusion Criteria:

1. 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.

2. Singleton living gestation

3. Cephalic presentation

4. Adequate pelvis

5. An informed written consent for the proposed study.

Exclusion Criteria:

1. Primigravids

2. Women with previous cesarean section

3. Multifetal gestation

4. Intrauterine fetal death

5. Malpresentations

6. Prematurity (<37 weeks )

7. Abnormally invasive placenta during the current pregnancy

8. Medical disorders with pregnancy

9. Contracted pelvis

10. Evidence of maternal infection

11. Allergy to azithromycin or other macrolides that is self-reported or documented in the
medical record.