Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol

NCT05215873 | Completed Phase 4 DMC

• 1 other identifier: FMASU MS 733/2020/2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to compare the efficacy and safety of oral misoprostol versus oxytocin in induction of labor in pregnant women with prelabor rupture of membranes at term.

Conditions

Prelabor Rupture of Membranes

Keywords

oxytocin; misoprostol

Outcome Measures

Primary Outcomes (1)

• vaginal delivery

  rate of successful vaginal delivery

  immediately after the intervention

Secondary Outcomes (5)

• induction to active phase time

  during the intervention

• Induction to delivery time

  during the intervention

• Apgar score

  The score is reported at 1 minute and 5 minutes after birth for all infants

• NICU admission

  within 24hours after birth

• maternal side effects

  during labour and within 24hours after birth

Study Arms (2)

misoprostol group

ACTIVE COMPARATOR

25µg misoprostol oral tablet every 4 hours with maximum200 µg

Drug: Misoprostol

oxytocin group

ACTIVE COMPARATOR

oxytocin infusion according to ASUMH local protocol: Put 3IU oxytocin (3000mIU) +50ml of normal saline in syringe pump= (60mIU/ml). Commence at 1ml/hour (1mIU/min) for 1/2 hour. * If contractions inadequate +fetal monitor healthy 2 ml/hour for 1/2 hour. * If contractions inadequate +fetal monitor healthy 4 ml/hour for 1/2 hour. * If contractions inadequate +fetal monitor healthy 6 ml/hour for 1/2 hour. * If contractions inadequate +fetal monitor healthy increase by 2ml/hr. for max. 27ml/hour. At any point there's fetal or maternal distress (e.g. pathological FHR pattern, antepartum hemorrhage, etc.) the study intervention will be stopped, and the maternal/fetal condition will be managed by cesarean section.

Drug: Syntocinon

Interventions

Misoprostol DRUG

a synthetic prostaglandin E1 analogue

Also known as: vagiprost

misoprostol group

Syntocinon DRUG

synthetic oxytocin

Also known as: oxytocin

oxytocin group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age (36-42 weeks).
• Prelabor rupture of membranes within the last 24hours
• Vertex presentation

You may not qualify if:

• History of medical diseases (HTN, diabetes milletus, systemic lupus erythematosus, cardiac, etc.).
• Antepartum hemorrhage
• Chorioamnionitis / prelabor rupture of membranes \>24hours
• Multiple pregnancy.
• Abnormal fetal heart rate pattern upon admission
• Intrauterine growth restriction
• Fetal malpresentation.
• Previous uterine scar.
• Estimated fetal weight more than 4kg.
• Patients already in labor
• Contraindication for prostaglandin/oxytocin use (allergy,..)

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Related Publications (3)

• Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2014 Jun 13;2014(6):CD001338. doi: 10.1002/14651858.CD001338.pub3.

  PMID: 24924489 BACKGROUND

• Zeteroglu S, Engin-Ustun Y, Ustun Y, Guvercinci M, Sahin G, Kamaci M. A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term. J Matern Fetal Neonatal Med. 2006 May;19(5):283-7. doi: 10.1080/14767050600589807.

  PMID: 16753768 BACKGROUND

• Ahmed RHM, Sweed MSE, El-Bishry GA, Hassan RK. Oxytocin Versus Oral Misoprostol for Induction of Labor in Pregnant Women with Term Prelabor Rupture of Membranes: a Randomized Clinical Trial. Reprod Sci. 2023 Dec;30(12):3507-3514. doi: 10.1007/s43032-023-01290-0. Epub 2023 Jul 13.

  PMID: 37442883 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed S Sweed, MD

  Professor

  STUDY DIRECTOR

• Gasser A Elbishry, MD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * 1st group (misoprostol group): induction of labor by 25µg misoprostol oral tablet every 4 hours with maximum200 µg. * 2nd group (oxytocin group:control group): induction of labor done by administration of oxytocin infusion according to ASUMH local protocol.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 31, 2022
• Study Start: February 1, 2021
• Primary Completion: January 15, 2022
• Study Completion: May 16, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After study completion and for 6months later
• Access Criteria: However, the repository is not decided upon yet

Locations

EG (1)