Cervical Ripening, Labor, Induced, Term Pregnancy
Conditions
Keywords
Induction of labor, Vaginal misoprostol, Vaginal dinoprostone, Primigravid women, Term pregnancy, Vaginal delivery, Cervical ripening
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.
Interventions
DRUGMisoprostol
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.
Sponsors
Mayo Hospital Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Vaginal Delivery | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | The time interval from administration of the assigned vaginal insert to vaginal delivery was measured in hours among participants who achieved successful vaginal delivery. |
| Peripartum Hemorrhage | 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. |
| Neonatal Intensive Care Unit Admission | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORSaher Anam
Mayo Hospital Lahore
Outcome results
None listed