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Completed

NCT Number: NCT04597528

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

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).

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Key information

Conditions

Pregnancy Related

Sex eligibility

Female

Study type

Observational

Primary location

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Caesarean Section (CS)

    Time frame: Till discharge from hospital or upto 4 days from day of delivery whichever is later

    Number of participants who underwent CS measured in percentage

  2. Number of neonates requiring intensive care

    Time frame: 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

    • Cardiopulmonary resuscitation (CPR)
    • invasive mechanical ventilatory care with a definitive airway
    • high flow nasal cannula (HFNC)
    • nasal continuous positive airway pressure (CPAP)ventilation

Secondary outcomes

  1. Time to delivery (induction to delivery time )

    Time frame: 24 hours

    Time taken from induction of delivery to delivery of the baby measured in hours and minutes

  2. Number of study participants with chorioamnionitis

    Time frame: Diagnosed at anytime, through delivery, upto 24 hours after birth

    Chorioamnionitis, documented as a clinical diagnosis before delivery

  3. Number of participants with Postpartum hemorrhage

    Time frame: Upto 12 weeks from day of delivery

    Postpartum hemorrhage, defined as answering "yes" for any of the questions as per a predefined checklist for

  4. Neonatal Mortality

    Time frame: Antepartum upto 30 days post delivery

    Number of neonatal deaths

  5. APGAR</= 7 at birth

    Time frame: 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.

  6. Number of infants with meconium aspiration syndrome (MAS)

    Time frame: Delivery through discharge or upto 4 days post delivery whichever is earlier

    Number of infants with MAS

Sponsors and collaborators

Lead sponsor

Jubilee Mission Medical College and Research Institute

Other

Registry information

Official study 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

Acronym: EIOL39

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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