Pregnancy RelatedEIOL39NCT04597528
Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study
An observational study of Pregnancy Related, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Elective Induction
- How many people
- 315 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2019to 17 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Singleton nulliparous gestation undergoing elective induction between 39weeks and 0days -39weeks and 6 days
Who may be able to join
- 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
Who cannot join
- Plan for caesarean delivery or any contraindication to vaginal delivery
- Foetal demise or known major foetal anomaly
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005
About this study
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
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.
Read more
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
- Being tested
- Elective Induction
- Keywords
- Elective induction of labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective InductionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Elective Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Caesarean Section (CS)
Number of participants who underwent CS measured in percentage
Measured: 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
- Cardiopulmonary resuscitation (CPR)
- invasive mechanical ventilatory care with a definitive airway
- high flow nasal cannula (HFNC)
- nasal continuous positive airway pressure (CPAP)ventilation
Measured: 24 hours from birth
Secondary outcomes (6)
Time to delivery (induction to delivery time )
Time taken from induction of delivery to delivery of the baby measured in hours and minutes
Measured: 24 hours
Number of study participants with chorioamnionitis
Chorioamnionitis, documented as a clinical diagnosis before delivery
Measured: Diagnosed at anytime, through delivery, upto 24 hours after birth
Number of participants with Postpartum hemorrhage
Postpartum hemorrhage, defined as answering "yes" for any of the questions as per a predefined checklist for
Measured: Upto 12 weeks from day of delivery
Neonatal Mortality
Number of neonatal deaths
Measured: Antepartum upto 30 days post delivery
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.
Measured: Upto 5 mins after birth
Number of infants with meconium aspiration syndrome (MAS)
Number of infants with MAS
Measured: Delivery through discharge or upto 4 days post delivery whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start17 Oct 2019
- Primary completion16 Apr 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athulya Shajan, Jubilee Mission Medical College and Research Institute
- Investigators
- Sareena Gilvaz, MD, DGO, Study director, Jubilee Mission Medical College and Research InstituteBindu Menon, MS, Study chair, Jubilee Mission Medical College and Research InstituteAthulya Shajan, MBBS, Principal investigator, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597528
- Sponsor's protocol ID
- 42/19/IEC/JMMC&RI
- Other IDs
- U1111-1245-7675
- Acronym
- EIOL39
- Status last verified
- Mar 2022
- First submitted
- 1 Oct 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597528
- Acronym / sponsor ID
- EIOL39 / 42/19/IEC/JMMC&RI
- Conditions
- Pregnancy Related
- Keywords
- Elective induction of labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective induction group | – | Other: Elective InductionNulliparous 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Singleton nulliparous gestation undergoing elective induction between 39weeks and 0days -39weeks and 6 days
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Plan for caesarean delivery or any contraindication to vaginal delivery
- Foetal demise or known major foetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective InductionAll 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. | Other | Elective induction group |
Primary outcome
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
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 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
6 secondary outcomes
Time to delivery (induction to delivery time )
Time frame: 24 hours
Number of study participants with chorioamnionitis
Time frame: Diagnosed at anytime, through delivery, upto 24 hours after birth
Number of participants with Postpartum hemorrhage
Time frame: Upto 12 weeks from day of delivery
Neonatal Mortality
Time frame: Antepartum upto 30 days post delivery
APGAR</= 7 at birth
Time frame: Upto 5 mins after birth
Number of infants with meconium aspiration syndrome (MAS)
Time frame: Delivery through discharge or upto 4 days post delivery whichever is earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sareena Gilvaz, MD, DGO study director
Jubilee Mission Medical College and Research Institute
Bindu Menon, MS study chair
Jubilee Mission Medical College and Research Institute
Athulya Shajan, MBBS principal investigator
Jubilee Mission Medical College and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Caesarean Section (CS) (time frame: Till discharge from hospital or upto 4 days from day of delivery whichever is later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.