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

NCT04597528 | Completed

• 2 other identifiers: 42/19/IEC/JMMC&RIU1111-1245-7675
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnancy Related

Keywords

Elective induction of labour

Outcome Measures

Primary Outcomes (2)

• 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 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

  24 hours from birth

Secondary Outcomes (6)

• Time to delivery (induction to delivery time )

  24 hours

• Number of study participants with chorioamnionitis

  Diagnosed at anytime, through delivery, upto 24 hours after birth

• 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

Study Arms (1)

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

Interventions

Elective Induction OTHER

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.

Elective induction group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Plan for caesarean delivery or any contraindication to vaginal delivery
• Foetal demise or known major foetal anomaly

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

Location

Study Officials

• Sareena Gilvaz, MD, DGO

  Jubilee Mission Medical College and Research Institute

  STUDY DIRECTOR

• Bindu Menon, MS

  Jubilee Mission Medical College and Research Institute

  STUDY CHAIR

• Athulya Shajan, MBBS

  Jubilee Mission Medical College and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 22, 2020
• Study Start: October 17, 2019
• Primary Completion: April 16, 2021
• Study Completion: May 17, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

IN (1)