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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Postpartum Endometritis; Azithromycin; Meconium Stained

Treatments: Drug: Placebo; Drug: Azithromycin capsule (Zithromax, Pfizer) (250 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT05118984

Azithromycin in MSAF cases

Details and patient eligibility

About

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.

Full 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).

Enrollment: 324 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 2 patient groups, including a placebo group

Azithromycin group

Active Comparator group

Description:

Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).

Treatment:

Drug: Azithromycin capsule (Zithromax, Pfizer) (250 mg)

Placebo group

Placebo Comparator group

Description:

placebo capsules (manufactured in pharmacy department with the same shape, color and consistency as Azithromycin capsule every 12hrs 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.

Treatment:

Drug: Placebo