| CTRI Number |
CTRI/2026/01/101382 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of elective induction versus spontaneous labor at 39 weeks of gestation |
|
Scientific Title of Study
|
A comparative study of maternal and perinatal outcomes following elective induction at 39 weeks versus expectant management in low risk singleton pregnancies at tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya Mahadevappa patil |
| Designation |
POST GRADUATE 1st year |
| Affiliation |
BLDE,HOSPITAL |
| Address |
1-1495/43,BHAGWATI NAGAR, BEHIND YATRIK NIVAS,KALABURAGI,585102
OBG OPD 2, GROUND FLOOR,SHRI BM PATIL, BLDE HOSPITAL , VIJAYAPURA
Gulbarga
KARNATAKA
585103
India |
| Phone |
9448412610 |
| Fax |
9448412610 |
| Email |
kavya1461998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Shiragur |
| Designation |
Professor |
| Affiliation |
BLDE,HOSPITAL |
| Address |
OBG OPD 2, GROUND FLOOR, SHRI BM PATIL ,BLDE HOSPITAL, VIJAYAPURA
OBG OPD 2, GROUND FLOOR, SHRI BM PATIL ,BLDE HOSPITAL, VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shobha.shiragur@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kavya Mahadevappa patil |
| Designation |
POST GRADUATE |
| Affiliation |
BLDE,HOSPITAL |
| Address |
1-1495/43,BHAGWATI NAGAR, BEHIND YATRIK NIVAS,KALABURAGI
OBG OPD NO 2, GROUND FLOOR,SHRI BM PATIL ,BLDE HOSPITAL,VIJAYAPURA
Gulbarga
KARNATAKA
585103
India |
| Phone |
9448412610 |
| Fax |
9448412610 |
| Email |
kavya1461998@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI BM PATIL,BLDE DU,
BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD, VIJAYAPURA. 586103 KARNATAKA,INDIA
|
|
|
Primary Sponsor
|
| Name |
BLDE HOSPITAL |
| Address |
SHRI BM PATIL, BLDE , VIJAYAPUR |
| Type of Sponsor |
Private medical college |
|
|
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 |
| kavya m patil |
BLDE |
BLDE OBG 2 OPD, VIJAYAPURA
Bijapur
KARNATAKA |
9448412610
kavya1461998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRIBMPATILMEDICALCOLLEGEHOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers consenting for the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancies
Cephalic presentation
Gestational age 39 weeks
Low risk pregnancies |
|
| ExclusionCriteria |
| Details |
Hypertensive disorders, gestational diabetes mellitus or any other medical illness
Previous caeserean section
Malpresentation
Oligohydramnios
Polyhydramnios
Fetal growth restriction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of caesarean delivery in elective induced patient
incidence in NICU admission |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
incidence of Neonatal complication
incidence in neonatal complications |
4 days |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
28/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To have better maternal and neonatal outcomes, if left for expectant management there are many maternal and neonatal complications when compared to elective induction at 39 weeks |