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

NCT07559812 | Active Not Recruiting

• 1 other identifier: Mayo5
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor, Induced; Cervical Ripening; Term Pregnancy

Keywords

Induction of labor; Vaginal misoprostol; Vaginal dinoprostone; Primigravid women; Term pregnancy; Vaginal delivery; Cervical ripening

Outcome Measures

Primary Outcomes (1)

• Successful Vaginal Delivery

  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 Outcomes (3)

• Time Interval From First Treatment to Vaginal Delivery

  From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.

• Peripartum Hemorrhage

  From delivery until 3 days after delivery.

• Neonatal Intensive Care Unit Admission

  Within 48 hours after delivery.

Study Arms (2)

Group M Misoprostol

EXPERIMENTAL

Participants in this group received 50 μg vaginal misoprostol insert under aseptic conditions for induction of labour.

Drug: Misoprostol

Group D Dinoprostone

ACTIVE COMPARATOR

Participants in this group received 3 mg vaginal dinoprostone insert under aseptic conditions for induction of labour

Drug: Dinoprostone 3 mg

Interventions

Misoprostol DRUG

50 μg misoprostol was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.

Group M Misoprostol

Dinoprostone 3 mg DRUG

3 mg dinoprostone was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.

Group D Dinoprostone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Misoprostol; Dinoprostone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Saher Anam

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 30, 2026
• Study Start: October 29, 2025
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

PA (1)