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

NCT05118984 | Completed Phase 4

• 1 other identifier: Azithromycin in MSAF cases
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

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.

Conditions

Meconium Stained; Azithromycin; Postpartum Endometritis

Keywords

Azithromycin; Placebo; Postpartum Endometritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Fetal necessity for NICU admission and/or mechanical ventilation.

  after delivery and within 1 week postartum

• Occurrence of meconium aspiration

  after delivery and within 1 week postpartum

• 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).

  wwithin 1 week postpartum

Study Arms (2)

Azithromycin group

ACTIVE COMPARATOR

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

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Azithromycin capsule (Zithromax, Pfizer) (250 mg) DRUG

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.

Azithromycin group

Placebo DRUG

A treatment that has no active properties

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University

Cairo, 002, Egypt

Location

Cairo University

Giza, 002, Egypt

Location

Related Links

• Premature Rupture of Membranes: Overview, Premature Rupture of Membranes (at Term), Premature Preterm Rupture of Membranes. Medscape.
• Management of meconium-stained newborns in the delivery room.
• Postpartum endometritis
• What Is The Real Risk Of Infection After Waters Break?
• • American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics (2016). Practice Bulletin No. 172: Premature Rupture of Membranes.
• Antibiotics for meconium-stained amniotic fluid in labour for preventing maternal and neonatal infections

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Gamal GamalEldin Youssef, PHD

  Cairo University

  STUDY CHAIR

• Eman Aly Hussein Aly, PHD

  Cairo University

  STUDY DIRECTOR

• Ahmed Samir Rashwan, PHD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomized to the 2 study groups according to a 2-block randomization list coded I or II at a 1:1 ratio. The randomization list will be prepared using a computer- generated random table by a statistician not otherwise involved in the study. The allocated groups will be masked in serially numbered sealed opaque envelopes that will be opened only after enrollment. Women who will be recruited give consent and open randomization envelopes in early labor, also the women will be recruited before revealing the allocation, the allocation will be blind to both the recruiter and the participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 12, 2021
• Study Start: February 16, 2021
• Primary Completion: May 31, 2021
• Study Completion: October 4, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

EG (2)