| CTRI Number |
CTRI/2021/04/033087 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [elective induction of labour at 39 weeks] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Induction of labor at 39 weeks versus expectant management |
|
Scientific Title of Study
|
Induction of labor at 39 weeks versus expectant management-A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Graishmi Charishma bondada |
| Designation |
Junior Resident(Academic) |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no. 113, PG 2, AIIMS RESIDENTIAL COMPLEX, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9000811117 |
| Fax |
|
| Email |
bondadagraishmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pruthwiraj Sethi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Associate professor, Obstetrics and Grynaecology, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pruthwiraj Sethi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Associate professor, Obstetrics and Grynaecology, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr Graishmi Charishma Bondada |
| Address |
Room No. 113, PG2 AIIMS Residential Complex, AIIMS Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Pruthwiraj Sethi |
Associate Professor, Obstetrics and Gynaecology, AIIMS Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Graishmi Charishma Bondada |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
Room no. 113, PG2, AIIMS residential complex, Sijua, Patrapada, Odisha- 751019
Department of Obstetrics and Gynaecology
Khordha
ORISSA |
9000811117
bondadagraishmi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:1||Obstetrics. Ayurveda Condition: NA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Elective induction of labor at 39 weeks |
Elective induction of labor at 39 weeks by either giving Dinoprostone gel or misoprostol tablets per vaginally followed by oxytocin infusion induction |
| Comparator Agent |
Expectant management of labor |
Expectant management according to institutional protocol |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All expectant mothers with non-anomalous singleton pregnancies at 39 weeks 0 day to 39 weeks 6 days |
|
| ExclusionCriteria |
| Details |
With a prior uterine scar,
with chronic maternal conditions that lead to indicated delivery,
non singleton pregnancies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Caesarian Delivery |
Not Applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of meconium stained amniotic fluid |
NA |
| Poor APGAR Score |
At 1 min and 5 min of life |
| Cord blood pH less than 7.2 |
Within 10 minutes for birth |
| Incidence of Hypoglycemia in baby |
In first 48 hours |
| Incidence of neonatal jaundice |
Within 72 hours of birth |
| Incidence of Neonatal asphyxia with APGAR less than 7 |
Within 1 min of birth |
| Neonatal sepsis |
Within 1 week of life |
| Requirement of ventilator support |
Within 72 hours of life |
| NICU admission |
Within 72 hours of life |
| Total duration of stay of mother and neonate in hospital |
For more than 1 week |
| Maternal pyrexia more than 100 degree F |
Within 1 week |
| Maternal stay in hospital |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2021 |
| 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="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In some studies, women who were electively induced at 39 weeks of gestation age have better overall outcomes among both mothers and neonates as estimated by total quality adjusted life years as well by reduction in adverse maternal and foetal outcomes. So in this study we want to see the rate of caesarean deliveries when electively induced at 39 weeks 0 day to 39 weeks 6 days and the adverse maternal and foetal outcomes when compared to expectant management group |