Oral Misoprostol Solution in Labor Induction

A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction

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.

Study Overview

• Status: Unknown
• Conditions: Labour,Induced
• Intervention / Treatment: Drug: Misoprostol

Detailed Description

Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 002
      • Recruiting
      • Ain Shams University
      • Contact: esam sa hagag, MBBCh; Phone Number: 01066813830; Email: essamhagag742@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: repetitive hourly dose of oral misoprostol; 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; 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.
Experimental: two hourly dose of oral misoprostol; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse maternal outcomes	As uterine hyper stimulation,fever,vomiting,shivering,nausea	in 24 hours
Adverse neonatal outcomes	As neonatal intensive care unit admission,non reassuring fetal heart rate	24 hours post partum

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: essam sa hagag, MBBCh, Ain Shams University

Publications and helpful links

General Publications

• 27986461

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Anticipated): December 18, 2019
• Study Completion (Anticipated): January 18, 2020

Study Registration Dates

• First Submitted: April 20, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: misoprostol in induction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No