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

NCT04597528 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 315

Last updated 2022-03-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jubilee Mission Medical College and Research Institute

    lead OTHER

Principal Investigators

  • Sareena Gilvaz, MD, DGO · Jubilee Mission Medical College and Research Institute

  • Bindu Menon, MS · Jubilee Mission Medical College and Research Institute

  • Athulya Shajan, MBBS · Jubilee Mission Medical College and Research Institute

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2021-04-16
Completion
2021-05-17

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597528 on ClinicalTrials.gov