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

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

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 Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Elective Induction

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 680005
      • Jubilee Mission Medical College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Singleton nulliparous gestation undergoing elective induction between 39weeks and 0days -39weeks and 6 days

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Elective induction group; 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

Other: Elective Induction; All patients admitted to the labour room would be approached to be enrolled in the study. Those satisfying the inclusion and exclusion criteria would be prospectively enrolled to the study after procuring an informed consent. If a patient appears to meet the criteria for the study, she will be told about the study and asked for written informed consent to participate. Consent may be obtained anytime from 34 weeks 0 days to 38 weeks 6 days of gestation. Data would be procured on a pre set proforma, entered in real time and safely stored. The data would later be abstracted to an excel sheet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Caesarean Section (CS)	Number of participants who underwent CS measured in percentage	Till discharge from hospital or upto 4 days from day of delivery whichever is later
Number of neonates requiring intensive care	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; Cardiopulmonary resuscitation (CPR); invasive mechanical ventilatory care with a definitive airway; high flow nasal cannula (HFNC); nasal continuous positive airway pressure (CPAP)ventilation	24 hours from birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to delivery (induction to delivery time )	Time taken from induction of delivery to delivery of the baby measured in hours and minutes	24 hours
Number of study participants with chorioamnionitis	Chorioamnionitis, documented as a clinical diagnosis before delivery	Diagnosed at anytime, through delivery, upto 24 hours after birth
Number of participants with Postpartum hemorrhage	Postpartum hemorrhage, defined as answering "yes" for any of the questions as per a predefined checklist for	Upto 12 weeks from day of delivery
Neonatal Mortality	Number of neonatal deaths	Antepartum upto 30 days post delivery
APGAR</= 7 at 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.	Upto 5 mins after birth
Number of infants with meconium aspiration syndrome (MAS)	Number of infants with MAS	Delivery through discharge or upto 4 days post delivery whichever is earlier

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute
• Investigators: Study Director: Sareena Gilvaz, MD, DGO, Jubilee Mission Medical College and Research Institute; Study Chair: Bindu Menon, MS, Jubilee Mission Medical College and Research Institute; Principal Investigator: Athulya Shajan, MBBS, Jubilee Mission Medical College and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): May 17, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Elective induction of labour
• Other Study ID Numbers: 42/19/IEC/JMMC&RI; U1111-1245-7675 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No