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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
50 μg misoprostol was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.
3 mg dinoprostone was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.
Mayo Hospital, Lahore
Lahore, Punjab Province, Pakistan
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.
Time frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 48 hours after delivery.
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