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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05118984
• Collaborator: (none)
• Enrollment: 324
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site: 162
• Patients Per Site Per Month: 21.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meconium Stained; Azithromycin; Postpartum Endometritis	Drug: Azithromycin capsule (Zithromax, Pfizer) (250 mg); Drug: Placebo	Phase 4

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Investigator)
• 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.
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: Feb 16, 2021
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: Oct 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Azithromycin group Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).	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 Comparator: 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.	Drug: Placebo; A treatment that has no active properties

Outcome Measures

Primary Outcome Measures

1. 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. [within 1 week from delivery]

   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.

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 neonatal fever , pneumonia and skin infection . [within 1 week from delivery]

   Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever.

Secondary Outcome Measures

1. Fetal necessity for NICU admission and/or mechanical ventilation. [after delivery and within 1 week postartum]

   Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF

2. Occurrence of meconium aspiration [after delivery and within 1 week postpartum]

   Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS.

3. 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock). [wwithin 1 week postpartum]

   Mothers follow up for incidence of side effects related to Azithromycin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	002
2	Cairo University	Giza		Egypt	002

Sponsors and Collaborators

• Cairo University

Investigators

• Study Chair: Gamal GamalEldin Youssef, PHD, Cairo University
• Study Director: Eman Aly Hussein Aly, PHD, Cairo University
• Study Director: Ahmed Samir Rashwan, PHD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Premature Rupture of Membranes: Overview, Premature Rupture of Membranes (at Term), Premature Preterm Rupture of Membranes. Medscape.
• 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.
• Management of meconium-stained newborns in the delivery room.
• Postpartum endometritis
• What Is The Real Risk Of Infection After Waters Break?
• Azithromycin
• 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
• • 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

Publications

None provided.

• Responsible Party: Ahmed Mohamed Kamal Zaghloul, Doctor, Cairo University
• ClinicalTrials.gov Identifier: NCT05118984
• Other Study ID Numbers: Azithromycin in MSAF cases
• First Posted: Nov 12, 2021
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Mohamed Kamal Zaghloul, Doctor, Cairo University: Azithromycin; Placebo; Postpartum Endometritis
• Additional relevant MeSH terms: Endometritis; Azithromycin

Study Results

No Results Posted as of Nov 12, 2021