Clinical trial NCT04597528: Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: Elective induction of labour
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 315
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singleton nulliparous gestation undergoing elective induction between 39weeks and 0days -39weeks and 6 days

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).


Eligibility criteria: Inclusion Criteria:

1. Nulliparous - no previous pregnancy beyond 20 weeks
2. Singleton gestation.
3. 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
4. Consenting to be part of the study

Exclusion Criteria:

1. Plan for caesarean delivery or any contraindication to vaginal delivery
2. Foetal demise or known major foetal anomaly

Primary outcomes:
measure: Incidence of Caesarean Section (CS)
timeFrame: Till discharge from hospital or upto 4 days from day of delivery whichever is later
measure: Number of neonates requiring intensive care
timeFrame: 24 hours from birth
Secondary outcomes:
measure: Time to delivery (induction to delivery time )
timeFrame: 24 hours
measure: Number of study participants with chorioamnionitis
timeFrame: Diagnosed at anytime, through delivery, upto 24 hours after birth
measure: Number of participants with Postpartum hemorrhage
timeFrame: Upto 12 weeks from day of delivery
measure: Neonatal Mortality
timeFrame: Antepartum upto 30 days post delivery
measure: APGAR</= 7 at birth
timeFrame: Upto 5 mins after birth
measure: Number of infants with meconium aspiration syndrome (MAS)
timeFrame: Delivery through discharge or upto 4 days post delivery whichever is earlier
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College and Research Institute
state: Kerala
Study officials:
affiliation: Jubilee Mission Medical College and Research Institute
name: Sareena Gilvaz, MD, DGO
role: STUDY_DIRECTOR
affiliation: Jubilee Mission Medical College and Research Institute
name: Bindu Menon, MS
role: STUDY_CHAIR
affiliation: Jubilee Mission Medical College and Research Institute
name: Athulya Shajan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: