Elective induction of labor at 39 weeks versus expectant management in low risk nulliparous women : a pilot randomized controlled trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Effect of elective induction of labour in low risk nulliparous women on caesarean delivery rates.
Study Overview
Brief Summary
Induction of labour is an intervention used to achieve vaginal delivery before spontaneous onset of labour. The objective of the present study to determine the effect of elective induction of labour in low risk nulliparous women on caesarean delivery rates. In this pilot randomized controlled trial a total of 60 women with low risk pregnancy will be randomised into 1:1 ratio aged 18 to 30 years at 38 weeks gestation from Department of Obstetrics & Gynaecology, RIMS, Ranchi. The intervention arm will receive Induction protocol at 39 weeks and control arm will receive the expectant management till 41 weeks or when medical indication arises. Women in both arms follow up will be done from the time of randomisation till discharge from hospital after delivery. Neonates will also be followed from delivery to the time of discharge. The primary outcome of the study will be number of participants with cesarean delivery and secondary outcome will be a composite of neonatal morbidity and perinatal mortality. The study will help to determine the effect of induction of labour for low risk nulliparous women in lowering the caesarean delivery rate.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Gestational age of 39 weeks to 39weeks + 5days (based on clinical information on LMP and USG in first trimester).
- •2.Nulliparous no prior history of delivery >20 weeks.
- •3.Singelton pregnancy with vertex presentation.
- •4.Those who give consent for elective induction of labour.
Exclusion Criteria
- •1.Malpresentation 2.Previous history of delivery >20 weeks.
- •3.Plan for caesarean delivery or contraindication to labour.
- •4.Signs of established labour.
- •5.Fetal demise or congenital malformation.
- •6.History of heparin or LMW heparin during current pregnancy.
- •7.Placenta previa, accrete.
- •8.Ruptured membranes.
- •9.Circlage in current pregnancy.
- •10.Known HIV positive.
- •11.Known oligohydramnios AFI <5, MVP <
- •12.Major medical illness e.g,diabetes mellitus adversely effecting pregnancy outcomes.
- •13.Fetal growth restriction , EFW< 10th percentile.
Outcomes
Primary Outcomes
Effect of elective induction of labour in low risk nulliparous women on caesarean delivery rates.
Time Frame: From delivery to Discharge
Secondary Outcomes
- Composite of severe neonatal morbidity and perinatal mortality.(From delivery to Discharge)