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

NCT ID: NCT04597528

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2021-05-17

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Elective Induction

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jubilee Mission Medical College and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Athulya Shajan

Junior Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sareena Gilvaz, MD, DGO

Role: STUDY_DIRECTOR

Jubilee Mission Medical College and Research Institute

Bindu Menon, MS

Role: STUDY_CHAIR

Jubilee Mission Medical College and Research Institute

Athulya Shajan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Jubilee Mission Medical College and Research Institute

Locations

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, India

Countries

India

Other Identifiers

U1111-1245-7675

Identifier Type: OTHER

Identifier Source: secondary_id

42/19/IEC/JMMC&RI

Identifier Type: -

Identifier Source: org_study_id