Oral Misoprostol Solution in Labor Induction

NCT03927807 | Unknown Phase 2 DMC

• 1 other identifier: misoprostol in induction
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Conditions

Labour,Induced

Keywords

misoprostol

Outcome Measures

Primary Outcomes (1)

• Mode of delivery

  Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.

  24 hours from the first dose of induction till delivery

Secondary Outcomes (2)

• Adverse maternal outcomes

  in 24 hours

• Adverse neonatal outcomes

  24 hours post partum

Study Arms (2)

repetitive hourly dose of oral misoprostol

EXPERIMENTAL

The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.

Drug: Misoprostol

two hourly dose of oral misoprostol

EXPERIMENTAL

The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity.

Drug: Misoprostol

Interventions

Misoprostol DRUG

This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

repetitive hourly dose of oral misoprostol; two hourly dose of oral misoprostol

Eligibility Criteria

• Gender Eligibility Details: 150 pregnant women who fulfill inclusion criteria.these will be subjected to history taking,physical examination,counseling and signing a written consent will be taken from each case.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparas
• Term pregnancy(equal or more than 37 wks)
• Bishop score \<6
• Cephalic presentation
• reassuring fetal heart rate pattern
• Not in labor ( no uterine contractions)
• Clinically adequate pelvis
• Singleton live pregnancy

You may not qualify if:

• Allergic to misoprostol or prostaglandin analogues
• Previous uterine scar( cesarean section,hysterotomy,myomectomy)
• Multiple fetal gestations
• Fetal demise
• Preterm labor
• Malpresentations
• Non reactive cardiotocography at admission
• Cephalo pelvic disproportion
• Fetal macrosomia

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 002, Egypt

RECRUITING

Related Publications (1)

• 27986461

  RESULT

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• essam sa hagag, MBBCh

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

essam sa hagag, MBBCh

CONTACT

01066813830; essamhagag742@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,clinical research

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: April 25, 2019
• Study Start: March 18, 2019
• Primary Completion: December 18, 2019
• Study Completion: January 18, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel.requestors will be required to sign a data access agreement.

Locations

EG (1)