Maternal and Perinatal Outcome After Elective Induction of Labour at Thirty Nine Weeks and Zero Days Upto Thirty Nine Weeks and Six Days in Nulliparous Singleton Pregnancies :a Prospective Observational Study in a Tertiary Care Centre
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 315
- Locations
- 1
- Primary Endpoint
- Incidence of Caesarean Section (CS)
Study Overview
Brief Summary
Adverse events are considered to increase in pregnancies extending beyond 39 weeks.
For multiparous patients, especially those with a favourable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of caesarean section.
However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation with the exception perhaps of the recent A Randomized Trial of Induction Versus Expectant Management (ARRIVE) trial. Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. There is a trend towards an increased rate of elective labour induction in pregnancies at 39 weeks, indicating that practitioners are more commonly using elective induction at this gestational age. The practice in India varies slightly from institute to institute.
The investigator intend to study the maternal and perinatal outcome, after elective induction of labour, at thirty nine weeks and zero days upto thirty nine and six days, amongst nulliparous singleton pregnancies followed up for the duration of their hospital stay, in Jubilee Mission Medical College and Research Institute (JMMC and RI).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Nulliparous - no previous pregnancy beyond 20 weeks
- •Singleton gestation.
- •Undergoing elective induction between 39weeks and 0days -39weeks and 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age
- •Consenting to be part of the study
Exclusion Criteria
- •Plan for caesarean delivery or any contraindication to vaginal delivery
- •Foetal demise or known major foetal anomaly
Outcomes
Primary Outcomes
Incidence of Caesarean Section (CS)
Time Frame: Till discharge from hospital or upto 4 days from day of delivery whichever is later
Number of participants who underwent CS measured in percentage
Number of neonates requiring intensive care
Time Frame: 24 hours from birth
Incidence of admission to neonatal intensive care unit (NICU) requiring cardio respiratory support within the first 24 hours of birth. Cardio respiratory support defined as needing any of the following within the first 24 hours of birth 1. Cardiopulmonary resuscitation (CPR) 2. invasive mechanical ventilatory care with a definitive airway 3. high flow nasal cannula (HFNC) 4. nasal continuous positive airway pressure (CPAP)ventilation
Secondary Outcomes
- Number of study participants with chorioamnionitis(Diagnosed at anytime, through delivery, upto 24 hours after birth)
- Number of infants with meconium aspiration syndrome (MAS)(Delivery through discharge or upto 4 days post delivery whichever is earlier)
- Time to delivery (induction to delivery time )(24 hours)
- Number of participants with Postpartum hemorrhage(Upto 12 weeks from day of delivery)
- Neonatal Mortality(Antepartum upto 30 days post delivery)
- APGAR</= 7 at birth(Upto 5 mins after birth)
Investigators
Athulya Shajan
Junior Resident
Jubilee Mission Medical College and Research Institute