| CTRI Number |
CTRI/2021/07/035072 [Registered on: 23/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between two methods of induction of labor pains, mechanical method (by insertion of Foley catheter) and chemical method ( by using dinoprostone gel) by inserting them in cervix of pregnant women . |
|
Scientific Title of Study
|
Comparison of Foley balloon catheter with intracervical dinoprostone gel for induction of labor in nulliparous women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANURADHA SHARMA |
| Designation |
PG student |
| Affiliation |
VMMC and Safdarjung hospital New Delhi |
| Address |
Room of HOU , unit 1 ,Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi
Room of HOU ,unit 1 , Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi
South West
DELHI
110023
India |
| Phone |
8949951809 |
| Fax |
|
| Email |
8949951809anu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JYOTSNA SURI |
| Designation |
Professor and consultant |
| Affiliation |
VMMC and Safdarjung hospital New Delhi |
| Address |
Room of HOU ,unit1 ,Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi
Room of HOU ,unit1 , Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi India
South West
DELHI
110023
India |
| Phone |
98100858358 |
| Fax |
|
| Email |
jyotsnasuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANURADHA SHARMA |
| Designation |
PG student |
| Affiliation |
VMMC and Safdarjung hospital New Delhi |
| Address |
Room of HOU , unit 1 , Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi
Room of HOU , unit 1 , Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi ,India
South West
DELHI
110023
India |
| Phone |
8949951809 |
| Fax |
|
| Email |
8949951809anu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Department of obstetrics and gynaecology VMMC and Safdarjung hospital New Delhi |
| Type of Sponsor |
Government 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 |
| ANURADHA SHARMA |
VMMC and Safdarjung hospital |
Department of obstetrics and gynaecology vardhman mahavir medical college and Safdarjung hospital New Delhi
South West
DELHI |
8949951809
8949951809anu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foley catheter and dinoprostone gel |
Intracervical insertion of Foley catheter and dinoprostone gel for comparison of induction of labour |
| Intervention |
cervigel insertion and Foley insertion |
Comparison of induction of labour by using cervigel and Foley catheter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Bischop score <6
Intact membrane
Reactive NST |
|
| ExclusionCriteria |
| Details |
Scarred uterus ,Fetal anomalies ,IUD ,severe preeclampsia , APH , cervicovaginal discharge , Asthma , Jaundice , Glaucoma ,Heart Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction Delivery Interval |
6to12 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Bishops score at 12 hours
Failed induction
Hyperstimulation
Tachysystole
Fetal distress
Chorioamnitis
Febrile morbidity
C_section requirement
Maximum dose of oxytocin required
Neonatal complications 1.APGAR at birth 2. Requirement for NICU care |
12hour |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 3 |
|
Date of First Enrollment (India)
|
30/07/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of Foley balloon catheter with intracervical dinoprostone gel for induction of labour in nulliparous women |