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

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Elective Induction

• Registration Number: NCT04597528
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-17
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2021-04-16
• Study Completion: 2021-05-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 315

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective induction group	Elective Induction	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

Primary Outcome Measures

Name	Time	Method
Incidence of Caesarean Section (CS)	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	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 Outcome Measures

Name	Time	Method
Number of study participants with chorioamnionitis	Diagnosed at anytime, through delivery, upto 24 hours after birth	Chorioamnionitis, documented as a clinical diagnosis before delivery
Number of infants with meconium aspiration syndrome (MAS)	Delivery through discharge or upto 4 days post delivery whichever is earlier	Number of infants with MAS
Time to delivery (induction to delivery time )	24 hours	Time taken from induction of delivery to delivery of the baby measured in hours and minutes
Number of participants with Postpartum hemorrhage	Upto 12 weeks from day of delivery	Postpartum hemorrhage, defined as answering "yes" for any of the questions as per a predefined checklist for
Neonatal Mortality	Antepartum upto 30 days post delivery	Number of neonatal deaths
APGAR</= 7 at birth	Upto 5 mins after birth	The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

Trial Locations

Locations (1)

Jubilee Mission Medical College and Research Institute; 🇮🇳 Thrissur, Kerala, India