Meconium StainedPhase 4NCT05118984
Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes
A Phase 4 study testing Azithromycin capsule (Zithromax, Pfizer) (250 mg) in people with Meconium Stained and Azithromycin, run by Cairo University at 2 sites in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meconium Stained, Azithromycin, Postpartum Endometritis
- What is being tested?
- Azithromycin capsule (Zithromax, Pfizer) (250 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Feb 2021to 4 Oct 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Primigravids
- Women with previous cesarean section
- Multifetal gestation
- Intrauterine fetal death
- Malpresentations
- Prematurity (<37 weeks )
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Meconium Stained, Azithromycin, Postpartum Endometritis
- Being tested
- Azithromycin capsule (Zithromax, Pfizer) (250 mg), Placebo
- Keywords
- Azithromycin, Placebo, Postpartum Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
A treatment that has no active properties
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin group | Active comparator | Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 1 week from delivery
Secondary outcomes (3)
Fetal necessity for NICU admission and/or mechanical ventilation.
Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF
Measured: 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.
Measured: 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
Measured: wwithin 1 week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start16 Feb 2021
- Primary completion31 May 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium StainedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Kamal Zaghloul, Cairo University
- Investigators
- Gamal GamalEldin Youssef, PHD, Study chair, Cairo UniversityEman Aly Hussein Aly, PHD, Study director, Cairo UniversityAhmed Samir Rashwan, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118984
- Sponsor's protocol ID
- Azithromycin in MSAF cases
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided