Induced Vaginal Delivery
Conditions
Brief summary
This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility & enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.
Interventions
induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women at 40 weeks or beyond * singleton pregnancy * Bishop score 4 or more * fetus in a cephalic presentation * Adequate fetal biophysical profile
Exclusion criteria
* Any signs of labour (Prelabor rupture of membranes) * Grand Multiparous women (parity of 4 or more) * IUFD * fetal weight \> 4 kg * BMI \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sucess of induction | number of women who delivered vaginally after induction | percentage of women with a successful vaginal delivery |
| Induction to delivery time | time from start of induction till delivery of the fetus | time lapse from receiving first dose of induction till delivery of the fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum hemorrhage | after delivery of the placenta | quantification of amount of postpartum bleeding |
| neonatal outcomes | at 1 and 5 minutes of delivery | Apgar Score at 1 and 5 minutes |
Countries
Egypt
Outcome results
None listed