A Phase 4 interventional study of Azithromycin capsule (Zithromax, Pfizer) (250 mg) and Placebo in Meconium Stained, Azithromycin and Postpartum Endometritis, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-12.
Sponsored by Cairo University · Phase 4, Interventional, and Prevention
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.
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).
53 studies on the registry are indexed under Endometritis; 9 are open to participants now.
This study's enrollment of 324 is above the median of 202 across 40 interventional studies indexed under Endometritis.
Browse Endometritis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).
Drug: Azithromycin capsule (Zithromax, Pfizer) (250 mg)
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.
Drug: Placebo
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.
A treatment that has no active properties
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.
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.
Time frame: within 1 week from delivery
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 .
Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever.
Time frame: within 1 week from delivery
Fetal necessity for NICU admission and/or mechanical ventilation.
Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF
Time frame: after delivery and within 1 week postartum
Occurrence of meconium aspiration
Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS.
Time frame: after delivery and within 1 week postpartum
2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).
Mothers follow up for incidence of side effects related to Azithromycin
Time frame: wwithin 1 week postpartum
Plan to share: Undecided
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University