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

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: Active, not recruiting
• Conditions: Labor, Induced; Term Pregnancy; Cervical Ripening
• Intervention / Treatment: Drug: Misoprostol; Drug: Dinoprostone 3 mg

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Interval From First Treatment to Vaginal Delivery	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	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	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

• Sponsor: Mayo Hospital Lahore
• Investigators: Principal Investigator: Saher Anam, Mayo Hospital Lahore

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): April 29, 2026
• Study Completion (Estimated): April 29, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Induction of labor; Cervical ripening; Vaginal delivery; Term pregnancy; Vaginal misoprostol; Vaginal dinoprostone; Primigravid women
• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E; Prostaglandins E, Synthetic; Misoprostol; Dinoprostone
• Other Study ID 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