| CTRI Number |
CTRI/2025/12/098242 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Vaginal misoprostol compared to sublingual misoprostol in initiation of labor pain in primigravidae with single foetus with premature rupture of membranes at gestational age of 36 weeks or later-A Randomized control trial |
|
Scientific Title of Study
|
Vaginal misoprostol compared to sublingual misoprostol in induction of labor in singleton primigravidae with premature rupture of membranes at gestational age of 36 weeks or later-A Double blinded, Randomized control, Superiority trial. |
| 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 Hastha R Aithal |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Hastha R Aithal
Senior resident
WCH Block 2nd floor, Obstetrics wing
Dept of Obstetrics and Gynaecology JIPMER Puducherry
Plot number 27,Indranagar
Vivekananda street
Puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7026340859 |
| Fax |
|
| Email |
hasthaaithal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latha Chaturvedula |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Latha Chathurvedula
Professor WCH Block
2nd floor,Faculty room
Dept of Obstetrics and Gynaecology
JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486008274 |
| Fax |
|
| Email |
jipoghod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latha Chaturvedula |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Latha Chathurvedula
Professor
WCH Block,@nd floor Faculty Room
Dept of Obstetrics and Gynaecology
JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486008274 |
| Fax |
|
| Email |
jipoghod@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Hospital,Dhanvanthari Nagar, Gorimedu
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrLatha Chathurvedula |
JIPMER |
WCH Block Jipmer
Puducherry
Pondicherry
PONDICHERRY |
9486008274
jipoghod@gmail.com |
| DrLatha Chathurvedula |
JIPMER |
Labor room Ground floor
WCH Block
JIPMER Dhanvantari Nagar
Puducherry
Pondicherry
PONDICHERRY |
9486008274
jipoghod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS cOMITTEE FOR INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sublingual misoprostol |
Group 2 will recieve T. misoprostol 25 mcg sublingually every 4th hourly-
upto maximum of 6 doses |
| Intervention |
Vaginal Misoprostol |
Group 1 will recieve Vaginal misoprostol 25mcg, every 4th hourly-Upto 4 doses
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.More than 18years of age
2.Bishop score of less than or equal to 4
3.Unscarred uterus |
|
| ExclusionCriteria |
| Details |
1.BMI >40
2.Allergic to prostaglandin
3.Antepartum haemorrhage
4.Foetal distress before induction process as
revealed by Non stress test
5.Cephalo pelvic disproportion(CPD)
6.Meconium stained liquour at admission |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in rate of caesarean section by Vaginal misoprostol compared to sublingual misoprostol |
The outcome will be assessed from the time of Induction till delivery of foetus.No postnatal follow up performed.Baseline details during delivery are recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Maternal & perinatal outcomes which includes
uterine hyperstimulation,foetal distress,meconium
stained liquor,NICU admission.
2.Induction to delivery interval |
All the outcomes will be assessed from the time of Induction till Delivery of the Foetus baseline parameters noted.No follow up is done post delivery |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
30/12/2025 |
| 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="2"
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
|
The sublingual route of administration leads to higher peak plasma levels and increased bioavailability compared to the vaginal route. However, plasma levels remain elevated for longer durations when administered vaginally. In one of the studies, sublingual group experienced nearly double the occurrence of uterine hyperstimulation, late fetal heart rate (FHR) decelerations during labor and Caesarean deliveries compared to vaginal group. 3 This study is aimed at comparing the safety and efficacy of sublingual with that of vaginal administration of misoprostol for labor induction in women carrying a live, full-term fetus with PROM Novelty-This is one of the few studies worldwide, comparing sublingual versus vaginal misoprostol in singleton primigravida with PROM |