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

NCT ID: NCT05118984

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2021-10-04

Brief Summary

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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

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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

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Meconium Stained Azithromycin Postpartum Endometritis

Keywords

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Azithromycin Placebo Postpartum Endometritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Azithromycin group

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

Group Type ACTIVE_COMPARATOR

Azithromycin capsule (Zithromax, Pfizer) (250 mg)

Intervention Type 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.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A treatment that has no active properties

Interventions

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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.

Intervention Type DRUG

Placebo

A treatment that has no active properties

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Kamal Zaghloul

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamal GamalEldin Youssef, PHD

Role: STUDY_CHAIR

Cairo University

Eman Aly Hussein Aly, PHD

Role: STUDY_DIRECTOR

Cairo University

Ahmed Samir Rashwan, PHD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Related Links

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http://emedicine.medscape.com/article/261137-overview#a2

Premature Rupture of Membranes: Overview, Premature Rupture of Membranes (at Term), Premature Preterm Rupture of Membranes. Medscape.

http://doi.org/10.1891/0730-0832.37.3.141

Management of meconium-stained newborns in the delivery room.

http://doi.org/10.1016/j.clp.2005.04.005

Postpartum endometritis

http://www.bellybelly.com.au/birth/what-is-the-real-risk-of-infection-after-waters-break/

What Is The Real Risk Of Infection After Waters Break?

http://doi.org/10.1097/AOG.0000000000001712

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics (2016). Practice Bulletin No. 172: Premature Rupture of Membranes.

http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC6823264&blobtype=pdf

Antibiotics for meconium-stained amniotic fluid in labour for preventing maternal and neonatal infections

Other Identifiers

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Azithromycin in MSAF cases

Identifier Type: -

Identifier Source: org_study_id