Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

February 17, 2014 updated by: Sherif Essam, Ain Shams University

Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial

To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
  • Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
  • Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11666
        • Recruiting
        • New Maternity Hospital - Ain Shams university
        • Contact:
        • Principal Investigator:
          • Sherif E Daoud, MB.Bch. Msc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Single vertex presentation.
  • Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
  • Bishop score <8 .
  • Not in labor.
  • Reassuring fetal heart rate (CTG for 20 min on the day of induction).
  • Valid indication for Induction of labor.

Exclusion Criteria:

  • Gestational age <37 weeks.
  • Patients with rupture of membranes.
  • Previous uterine scar.
  • Fetal malpresentation.
  • Multiple pregnancy.
  • Significant antepartum hemorrhage
  • Uncontrolled DM.
  • Severe Pre-eclampsia or Eclampsia
  • If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,…..etc.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cases
A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy.
Drug: Misotac® Sigma Pharmaceutical Industries
The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.
Other Names:
  • Misotac (Misoprostol)
Active Comparator: Control
Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
Drug: Dinoprostone 3 mg
Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
Other Names:
  • Dinoglandin®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Induction delivery interval i.e. Time from start of medication till delivery
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients delivered vaginally within the first 24 hours
Time Frame: 24 hours
24 hours
Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor
Time Frame: 12 hours
12 hours
Duration of 1st,2nd and 3rd stages of labor
Time Frame: 24 hours
24 hours
Maternal complications
Time Frame: 24 hours
uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.
24 hours
Mode of delivery
Time Frame: 24 hours
Vaginal , instrumental or Cesarean section
24 hours
Neonatal outcome
Time Frame: 24 hours
Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Amr H Yehia, MD, MRCOG, Ain Shams University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • elkont1984

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