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

Pregnancy Related Clinical Trial

— EIOL39  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597528
• Other study ID #: 42/19/IEC/JMMC&RI
• Secondary ID: U1111-1245-7675
• Status: Completed
• Start date: October 17, 2019
• Est. completion date: May 17, 2021

Study information

• Verified date: March 2022
• Source: Jubilee Mission Medical College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: May 17, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
India	Jubilee Mission Medical College and Research Institute	Thrissur	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of study participants with chorioamnionitis	Chorioamnionitis, documented as a clinical diagnosis before delivery	Diagnosed at anytime, through delivery, upto 24 hours after birth
Secondary	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
Secondary	Neonatal Mortality	Number of neonatal deaths	Antepartum upto 30 days post delivery
Secondary	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
Secondary	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