Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction

February 9, 2018 updated by: Oihane Lapuente Ocamica

Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial

This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women over 18
  • single pregnancy
  • cephalic presentation
  • intact membranes
  • unfavorable cervix ( less than 6 Bishop )
  • CTGR not reactive decelerative
  • Signed informed consent by the patient.

Exclusion Criteria:

  • prior Cesarean section or previous uterine surgery .
  • Allergy or intolerance to any of the study drugs
  • stillbirth
  • uterine growth restricted fetuses
  • contraindication for vaginal delivery
  • Anterior placenta
  • Multiparity
  • moderate to severe heart disease
  • hypertensive disorders of pregnancy
  • Suspected chorioamnionitis
  • Coagulation disorders
  • history of epileptic seizures
  • liver or kidney disease
  • Cognitive impairment or bad knowledge of Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral misoprostol
Administration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment
Drug: Oral misoprostol
hourly titrated misoprostol
Active Comparator: Vaginal misoprostol
vaginal misoprostol, 25 microgs every 4 hours
Drug: Vaginal misoprostol
Administration of 25 microgs every 6 hours, maximum 150 microgr
Active Comparator: Vaginal dinoprostone
vaginal dinoprostone, 10 mg during 24 hours (maximum)
Drug: Vaginal dinoprostone
Vaginal delivery system of 10mg of dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group
Time Frame: 12 hours
12 hours
The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group
Time Frame: 24 hours
24 hours
The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group
Time Frame: 12 hours
12 hours
Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time Frame: 24 hours
24 hours
The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time Frame: 24 hours
24 hours
Compare the percentage of women requiring oxytocin in each group
Time Frame: 24 hours
24 hours
The percentage of women in each group having tachysystole
Time Frame: 24 hours
24 hours
Compare the number of women suffering from uterine rupture in each group
Time Frame: 24 hours
24 hours
The percentage of women in each branch having uterine hypertonia
Time Frame: 24 hours
24 hours
Maternal morbility-mortality among pregnant participants
Time Frame: up to 180 days
up to 180 days
Compare fetal or neonatal morbility-mortality among the 3 groups
Time Frame: up to 180 days
up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oihane Lapuente Ocamica

Investigators

  • Principal Investigator: Oihane Lapuente Ocamica, OIHANE.LAPUENTEOCAMICA@osakidetza.eus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV-MV-MO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor, Induced

Clinical Trials on Oral misoprostol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe