| CTRI Number |
CTRI/2024/05/067927 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficacy of oral misoprostol vs dinoprostone gel in labor |
|
Scientific Title of Study
|
A randomised control study to assess the safety and efficacy of oral misoprostol versus intracervical dinoprostone gel in induction of labour |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suvetha Shree |
| Designation |
Postgraduate |
| Affiliation |
ACS Medical college and hospital |
| Address |
Department of obstetrics and gynaecology, ACS medical college and hospital , Poonamallee High Road, velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9445699767 |
| Fax |
|
| Email |
suvethashree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Gnanasekaran |
| Designation |
Professor, Obstetrics and gynaecology |
| Affiliation |
ACS medical college and hospital |
| Address |
ACS medical college and hospital , Poonamallee High Road, velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9003166440 |
| Fax |
|
| Email |
sekaran.viji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi Gnanasekaran |
| Designation |
Professor, Obstetrics and gynaecology |
| Affiliation |
ACS medical college and hospital |
| Address |
ACS medical college and hospital , Poonamallee High Road, velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9003166440 |
| Fax |
|
| Email |
sekaran.viji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support- ACS medical college and hospital, Poonamallee High Road, Vellappanchavadi, Chennai-600077, Tamilnadu, India
Monetary support- Self |
|
|
Primary Sponsor
|
| Name |
Dr Suvetha Shree |
| Address |
Department of obstetrics and gynaecology, ACS Medical college and hospital, Velapanchavadi, Chennai-600077, Tamilnadu, India. |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Suvetha Shree |
ACS medical college and hospital |
Obstetrics OPD and Labor room, department of obstetrics and gynaecology, ACS medical college and hospital , Poonamallee High Road, velappanchavadi, Chennai
Chennai
TAMIL NADU |
9445699767
suvethashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS Medical college and hospital, A constituent unit of Dr. M.G.R. Educational and research institute ( deemed to be university) Institutional ethics committee, ACSMCH |
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: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dinoprostone gel |
0.5mg of intracervical dinoprostone gel 6th hourly upto 18 hours given for cervical ripening and induction of labour |
| Comparator Agent |
Oral tablet misoprostol |
50mcg of oral tablet misoprotol is given every 4 hours for 16 hours for cervical ripening and induction of labour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Post dated pregnancy, singleton pregnancy, vertex presentation, other indications of induction like GDM,GHTN,FGR |
|
| ExclusionCriteria |
| Details |
Multiple gestation, preterm, non vertex presentation, previous LSCS, cephalopelvic disproportion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of mode of delivery-Normal vaginal delivery or LSCS |
Induction to delivery interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perinatal complications, neonatal complications |
Up to 3 days after delivery |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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)
|
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
|
- PRIMARY OBJECTIVE:
- To compare safety and efficacy of oral misoprostol (25 microgram) with intracervical dinoprostone gel (0.5 mg) for cervical ripening and induction of labour
- SECONDARY OBJECTIVE:
- 1. To compare change in bishop score.
- 2. To compare mode of delivery.
- 3. To compare the need for augmentation of labour in active phase.
- 4. To compare side effects and neonatal outcome.
- 5. To compare the cost effectiveness of both.
|