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

Postpartum Endometritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118984
• Other study ID #: Azithromycin in MSAF cases
• Status: Completed
• Phase: Phase 4
• Start date: February 16, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: October 4, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Azithromycin
• Endometritis
• Postpartum Endometritis

Intervention

Drug:
• Azithromycin capsule (Zithromax, Pfizer) (250 mg)
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.
• Placebo
A treatment that has no active properties

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 1 week from delivery
Primary	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.	within 1 week from delivery
Secondary	Fetal necessity for NICU admission and/or mechanical ventilation.	Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF	after delivery and within 1 week postartum
Secondary	Occurrence of meconium aspiration	Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS.	after delivery and within 1 week postpartum
Secondary	2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).	Mothers follow up for incidence of side effects related to Azithromycin	wwithin 1 week postpartum

External Links

•   • American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics (2016). Practice Bulletin No. 172: Premature Rupture of Membranes.
•   A Retrospective Study on the Risk of Respiratory Distress Syndrome in Singleton Pregnancies with Preterm Premature Rupture of Membranes between 24+0 and 36+6 Weeks, Using Regression Analysis for Various Factors
•   Antibiotics for meconium-stained amniotic fluid in labour for preventing maternal and neonatal infections
•   Antibiotics for women with prelabour rupture of membranes at term, undergoing induction of labour after 12 hours - A randomized controlled trial. Sri Lanka Journal of Obstetrics and Gynaecology, 42(1), 12-20.
•   Azithromycin
•   Management of meconium-stained newborns in the delivery room.
•   Postpartum endometritis
•   Premature Rupture of Membranes: Overview, Premature Rupture of Membranes (at Term), Premature Preterm Rupture of Membranes. Medscape.
•   What Is The Real Risk Of Infection After Waters Break?