| CTRI Number |
CTRI/2021/10/037487 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Induction of labor by dinoprostone gel 0.5mg intracervical followed by oxytocin stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Elective induction of labor at 39 weeks versus expectant management in low risk nulliparous women |
|
Scientific Title of Study
|
Elective induction of labor at 39 weeks versus expectant management in low risk nulliparous women : a pilot randomized controlled trial |
| Trial Acronym |
EIOL-NUL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Kumari |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical sciences |
| Address |
Dept. of Obgyn , Rajendra institute of Medical Sciences, Ranchi
House No. 16, Annapurna enclave,, Maitri Marg, Bariatu housing Colony , Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
9471521226 |
| Fax |
|
| Email |
dr_karchana@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
AArchana Kumari |
| Designation |
associate Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DDept. of OBGYN, Rajendra Institute of Medical Scioences, Ranchi
House number 16, Annapurna Enclave, Maitri Marg, Bariatu Housing Colony, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
9471521226 |
| Fax |
|
| Email |
dr_karchana@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Aakanksha |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical sciences |
| Address |
Aakanksha, Junior Resident, Dept. of OBGYN, Rajendra Institute of Medical Sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
|
| Fax |
|
| Email |
singhshilu39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences , Ranchi, Jharkhand |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana Kumari |
Rajendra Institute of Medical Sciences, New Delhi |
Dept. of Obgyn
Ranchi
JHARKHAND |
9471521226
dr_karchana@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RIMS Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O610||Failed medical induction of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Expected Management |
Expected management |
| Intervention |
Induction Protocol |
Dose: dinoprostone gel 0.5 mg (maximum three doses)
Frequency : 6 hourly
Route : intracervical
Duration : 18-24 hours
Induction protocol: cervical priming will be done by dinoprostone gel 0.5mg intracervical 6 hourly to maximum 3 doses, followed by oxytocin stimulation till adequate contactions i.e, atleast three contractions of 45 sec in 10 minutes occur. Induction protocol will be guided by bishop score of the women. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Gestational age of 39 weeks to 39weeks + 5days (based on clinical information on LMP and USG in first trimester).
2. Nulliparous no prior history of delivery >20 weeks.
3. Singelton pregnancy with vertex presentation.
4. Those who give consent for elective induction of labour.
|
|
| ExclusionCriteria |
| Details |
1. Malpresentation
2. Previous history of delivery >20 weeks.
3. Plan for caesarean delivery or contraindication to labour.
4. Signs of established labour.
5. Fetal demise or congenital malformation.
6. History of heparin or LMW heparin during current pregnancy.
7. Placenta previa, accrete.
8. Ruptured membranes.
9. Circlage in current pregnancy.
10. Known HIV positive.
11. Known oligohydramnios AFI <5, MVP <2.
12. Major medical illness e.g,diabetes mellitus adversely effecting pregnancy outcomes.
13. Fetal growth restriction , EFW< 10th percentile.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of elective induction of labour in low risk nulliparous women on caesarean delivery rates. |
From delivery to Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Composite of severe neonatal morbidity and perinatal mortality. |
From delivery to Discharge |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
after the trial is over |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Induction of labour is an intervention used to achieve vaginal delivery before spontaneous onset of labour. The objective of the present study to determine the effect of elective induction of labour in low risk nulliparous women on caesarean delivery rates. In this pilot randomized controlled trial a total of 60 women with low risk pregnancy will be randomised into 1:1 ratio aged 18 to 30 years at 38 weeks gestation from Department of Obstetrics & Gynaecology, RIMS, Ranchi. The intervention arm will receive Induction protocol at 39 weeks and control arm will receive the expectant management till 41 weeks or when medical indication arises. Women in both arms follow up will be done from the time of randomisation till discharge from hospital after delivery. Neonates will also be followed from delivery to the time of discharge. The primary outcome of the study will be number of participants with cesarean delivery and secondary outcome will be a composite of neonatal morbidity and perinatal mortality. The study will help to determine the effect of induction of labour for low risk nulliparous women in lowering the caesarean delivery rate. |