Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study (EIOL39)

Jubilee Mission Medical College and Research Institute

Status: Completed

Conditions: Pregnancy Related

Treatments: Other: Elective Induction

Study type: Observational

Funder types: Other

Identifiers

NCT04597528

42/19/IEC/JMMC&RI

U1111-1245-7675 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 315 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

315 participants in 1 patient group

Elective induction group

Description:

Nulliparous singleton gestations 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

Treatment:

Other: Elective Induction