Clinical trial NCT05118984: Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meconium Stained
Azithromycin
Postpartum Endometritis
Keywords: Azithromycin
Placebo
Postpartum Endometritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participant will be allocated to one of two groups :

Group 1 will be offered Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).

Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, colour and consistency as Azithromycin capsule for 3 days). A single pharmacist will be responsible for manufacturing of placebo capsules and packing all medications into sterile boxes and labelling of them as 1 or 2.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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).

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: within 1 week from delivery
measure: 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 .
timeFrame: within 1 week from delivery
Secondary outcomes:
measure: Fetal necessity for NICU admission and/or mechanical ventilation.
timeFrame: after delivery and within 1 week postartum
measure: Occurrence of meconium aspiration
timeFrame: after delivery and within 1 week postpartum
measure: 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).
timeFrame: wwithin 1 week postpartum
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Gamal GamalEldin Youssef, PHD
role: STUDY_CHAIR
affiliation: Cairo University
name: Eman Aly Hussein Aly, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed Samir Rashwan, PHD
role: STUDY_DIRECTOR
References: