Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes
- Conditions
- AzithromycinMeconium StainedPostpartum Endometritis
- Interventions
- Registration Number
- NCT05118984
- Lead Sponsor
- Cairo University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 324
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azithromycin group Azithromycin capsule (Zithromax, Pfizer) (250 mg) Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days). Placebo group Placebo 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.
- Primary Outcome Measures
Name Time Method 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 . within 1 week from delivery Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever.
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. 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.
- Secondary Outcome Measures
Name Time Method 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock). wwithin 1 week postpartum Mothers follow up for incidence of side effects related to Azithromycin
Fetal necessity for NICU admission and/or mechanical ventilation. after delivery and within 1 week postartum Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF
Occurrence of meconium aspiration 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.
Trial Locations
- Locations (1)
Cairo University
🇪🇬Giza, Egypt