| CTRI Number |
CTRI/2024/10/075454 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effect of two methods for inducing labour for normal delivery in a pregnant female |
|
Scientific Title of Study
|
COMPARISON OF INTRACERVICAL FOLEY CATHETER WITH DINOPROSTONE GEL COADMINISTRATION VERSUS INTRACERVICAL DINOPROSTONE GEL ALONE FOR INDUCTION OF LABOUR IN AN OPEN LABEL RANDONMISED CONTROLTRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREETI PRIYADARSHANI |
| Designation |
CONSULTANT |
| Affiliation |
AIIMS GORAKHPUR UP |
| Address |
Department of Obstretrics and Gynaecologist
KUNRAGHAT ROAD KAVYANJALI HEIGHTS ROOM NO 112
UP 273008
AIIMS GORAKHPUR UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8860353575 |
| Fax |
|
| Email |
DRPREETI.PRIYADARSHANI@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
MHALO SHITIRI |
| Designation |
PG STUDENT |
| Affiliation |
AIIMS GORAKHPUR UP |
| Address |
AIIMS GORAKHPUR
GIRLS HOSTEL ROOM NO 103
UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8787466708 |
| Fax |
|
| Email |
RMHALOSHITIRI@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
MHALO SHITIRI |
| Designation |
PG STUDENT |
| Affiliation |
AIIMS GORAKHPUR UP |
| Address |
AIIMS GORAKHPUR
GIRLS HOSTEL
UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8787466708 |
| Fax |
|
| Email |
RMHALOSHITIRI@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| AIIMS GORAKHPUR KUNRAGHAT UP INDIA PINCODE -273008 |
|
|
Primary Sponsor
|
| Name |
DR MHALO |
| Address |
AIIMS GKP KUNRAGHAT ,UP 273008
INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS GORAKPUR UP |
AIIMS GORAKHPUR ,UP 273008
INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MHALO SHITIRI |
AIIMS GORAKHPUR ,UP |
AIIMS GORAKPUR,UP
labour room no-1 obstretrics and gyneacology department
Gorakhpur
UTTAR PRADESH |
8787466708
RMHALOSHITIRI@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREGNANT WOMEN AT TERM GESTATION FOR DELIVERY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRACERVICAL DINOPROSTONE GEL |
INTRACERVICAL DINOPROSTONE GEL 0.5MG (TOTAL DOSE -1.5 MG ) WILL BE GIVEN 8 HOURLY FOR 24 HOURS |
| Comparator Agent |
INTRACERVICAL DINOPROSTONE GEL WITH INTRACERVICAL FOLEY CATHETER |
IT WILL BE GIVEN 8 HOURLY FOR 24 HOURS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Nulliparous women with Bishop 6 or less on admission.
2. Term pregnancy (37-42 weeks).
3. Singleton fetus with cephalic presentation.
4. Reactive Non stress test at time of admission.
5. Intact bag of membranes
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To compare the Induction to Delivery interval (IDI), that is the time from first intervention to time of vaginal delivery among the two groups |
24 HOURS
DOSE OF DINOPROSTONE GEL-0.5 MG (TOTAL DOSE -1.5 MG) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Modified Bishop score over 8 hours ,16 hours and 24 hours
2. To compare the time taken to reach from induction to active phase of labour (≥5cm cervical dilatation) in women between the two groups.
3. To compare the development of maternal complication including tachysystole, chorioamnionitis and endometritis between the two groups.
|
Change in Modified Bishop score over 8 hours ,16 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/10/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
We expect to establish the superiority of a combination of intracervical Foley catheter with Dinoprostone gel as compared to Dinoprostone gel for induction of labour. As this addition to the induction protocol is a cheap and readily available, we aim to increase rates of successful induction and decrease Caesarean rates with the help of the findings of this study. |