Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy

April 27, 2026 updated by: Adeel Ahmed, Mayo Hospital Lahore
This randomized controlled trial was conducted to compare vaginal misoprostol and vaginal PGE2 (dinoprostone) for induction of labour in primigravid women with term pregnancy. Labour induction is commonly required when pregnancy reaches term but spontaneous labour has not started. Different medicines are used to soften the cervix and start uterine contractions, but their effectiveness may vary. A total of 240 primigravid women with singleton pregnancy at 40 weeks or more of gestation, who were not in spontaneous labour and were planned for induction of labour, were included. Participants were allocated into two equal groups. Women in Group M received a 50 μg vaginal misoprostol insert, while women in Group D received a 3 mg vaginal dinoprostone insert. Both medicines were given under aseptic conditions in the inpatient obstetrics setting. The main purpose of the study was to compare the proportion of women who achieved successful vaginal delivery after induction. The study also assessed the time interval from first treatment to vaginal delivery among successful cases. Additional maternal and neonatal outcomes included peripartum hemorrhage, premature rupture of membranes, and admission of the newborn to the neonatal intensive care unit within 48 hours after delivery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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 (Actual)

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.
240

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.
  • Not Applicable

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

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Mayo Hospital, Lahore

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women age 18-45 years, primigravida, undergoing induction of labour at Gestational age ≥ 40 weeks by last menstrual period (LMP)
  • Not having spontaneous labor at 40 weeks of gestation by last menstrual period (LMP)

Exclusion Criteria:

  • Absent fetal cardiac activity on CTG
  • Non-reassuring CTG on admission
  • Anomalous fetus on ante-natal ultrasound record.
  • Not willing to participate.

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: Single

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: Group M Misoprostol
Participants in this group received 50 μg vaginal misoprostol insert under aseptic conditions for induction of labour.
Drug: Misoprostol
50 μg misoprostol was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.
Active Comparator: Group D Dinoprostone
Participants in this group received 3 mg vaginal dinoprostone insert under aseptic conditions for induction of labour
Drug: Dinoprostone 3 mg
3 mg dinoprostone was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.

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
Measure Description
Time Frame
Successful Vaginal Delivery
Time Frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Successful vaginal delivery was assessed as the proportion of participants who achieved vaginal delivery after induction of labour with the assigned study drug.
From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.

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
Time Interval From First Treatment to Vaginal Delivery
Time Frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
The time interval from administration of the assigned vaginal insert to vaginal delivery was measured in hours among participants who achieved successful vaginal delivery.
From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Peripartum Hemorrhage
Time Frame: From delivery until 3 days after delivery.
Peripartum hemorrhage was recorded as Yes when excessive blood loss was associated with both blood transfusion during or within 3 days after delivery and a fall in hemoglobin of ≥2 g/dL from baseline. Baseline hemoglobin was measured at admission to the labour room and post-delivery hemoglobin was assessed 48 hours after delivery.
From delivery until 3 days after delivery.
Neonatal Intensive Care Unit Admission
Time Frame: Within 48 hours after delivery.
Neonatal intensive care unit admission was assessed as the proportion of newborns admitted to the neonatal intensive care unit after delivery.
Within 48 hours after delivery.

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.
Mayo Hospital Lahore

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.
  • Principal Investigator: Saher Anam, Mayo Hospital Lahore

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)

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.
October 29, 2025

Primary Completion (Estimated)

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.
April 29, 2026

Study Completion (Estimated)

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.
April 29, 2026

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).
April 21, 2026

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.
April 27, 2026

First Posted (Actual)

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.
April 30, 2026

Study Record Updates

Last Update Posted (Actual)

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.
April 30, 2026

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.
April 27, 2026

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.
April 1, 2026

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.
  • Mayo5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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