Health Condition 1: null- uncomplicated singleton pregnant women at 40 weeks of gestation
Conditions
Interventions
Intervention1: Misoprostol: Single low dose (25 µg) misoprostol vaginally given on outpatient basis at 40 completed weeks of gestation
Control Intervention1: nil: no intervention
Sponsors
University College of Medical Sciences and Guru Teg Bahadur HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: Total number of 130 subjects of uncomplicated singleton pregnancy at 40 completed weeks (gestational age based on LMP or scan before 20 weeks of gestation) of gestation with vertex presentation with Bishop score ï?£5. • Intact membranes or no leaking per-vaginum • No contraindication for vaginal delivery • Normal Biophysical profile
Exclusion criteria
Exclusion criteria: • Grand multiparity (ï?³5) • Any maternal systemic disease • Previous LSCS / uterine scar • Unexplained vaginal bleeding • EFW >3.5 kg • Fetal growth restriction, oligohydramnios (AFI ï?£5) • Fetal anomalies • Contraindications for misoprostol (allergy, cardiovascular diseases, renal impairment etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Number of women entering spontaneous labor between 40 to 41 weeks of gestationTimepoint: 41 weeks of gestation or spontaneous labor (which ever is earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Time from enrolment in study till delivery â?¢ Need for cesarean section â?¢ Neonatal outcome in early neonatal age (Apgar score at 1 and 5 minutes, meconium stained liquor, neonatal morbidity and mortality) â?¢ Side effects of misoprostol in mother (nausea, vomiting, diarrhea, fever and abnormal uterine activity, etc.) Timepoint: one week | — |
Countries
India
Contacts
Public ContactNIKITA JINDAL
DEPARTMENT OF OBG, UCMS & GTB HOSPITAL
Outcome results
None listed