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

Primary Purpose

Meconium Stained, Azithromycin, Postpartum Endometritis

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Azithromycin capsule (Zithromax, Pfizer) (250 mg)
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meconium Stained focused on measuring Azithromycin, Placebo, Postpartum Endometritis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Cairo University
  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Azithromycin group

Placebo group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Fetal necessity for NICU admission and/or mechanical ventilation.
Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF
Occurrence of meconium aspiration
Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS.
2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).
Mothers follow up for incidence of side effects related to Azithromycin

Full Information

First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05118984
Brief Title
Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Stained, Azithromycin, Postpartum Endometritis
Keywords
Azithromycin, Placebo, Postpartum Endometritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin group
Arm Type
Active Comparator
Arm Description
Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin capsule (Zithromax, Pfizer) (250 mg)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A treatment that has no active properties
Primary Outcome Measure Information:
Title
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.
Description
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
Title
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 .
Description
Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever.
Time Frame
within 1 week from delivery
Secondary Outcome Measure Information:
Title
Fetal necessity for NICU admission and/or mechanical ventilation.
Description
Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF
Time Frame
after delivery and within 1 week postartum
Title
Occurrence of meconium aspiration
Description
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
Title
2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock).
Description
Mothers follow up for incidence of side effects related to Azithromycin
Time Frame
wwithin 1 week postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal GamalEldin Youssef, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eman Aly Hussein Aly, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Samir Rashwan, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://emedicine.medscape.com/article/261137-overview#a2
Description
Premature Rupture of Membranes: Overview, Premature Rupture of Membranes (at Term), Premature Preterm Rupture of Membranes. Medscape.
URL
http://doi.org/10.4038/sljog.v42i1.7927
Description
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.
URL
http://doi.org/10.1891/0730-0832.37.3.141
Description
Management of meconium-stained newborns in the delivery room.
URL
http://doi.org/10.1016/j.clp.2005.04.005
Description
Postpartum endometritis
URL
http://www.bellybelly.com.au/birth/what-is-the-real-risk-of-infection-after-waters-break/
Description
What Is The Real Risk Of Infection After Waters Break?
URL
http://doi.org/10.1155/2018/7162478
Description
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
URL
http://doi.org/10.1097/AOG.0000000000001712
Description
• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics (2016). Practice Bulletin No. 172: Premature Rupture of Membranes.
URL
http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC6823264&blobtype=pdf
Description
Antibiotics for meconium-stained amniotic fluid in labour for preventing maternal and neonatal infections

Learn more about this trial

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

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