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NCT Number: NCT07559812

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

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

Dinoprostone 3 mg

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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