| CTRI Number |
CTRI/2025/08/092551 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [comparison between sequential and concurrent use of oral misoprostol and foleys ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized controlled trial comparing concurrent and sequential methods using Oral Misoprostol and Foleys Catheter. |
|
Scientific Title of Study
|
Induction of labour-An enigma,Concurrent versus sequential use of oral misoprostol plus foleys catheter for 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 Preetha George |
| Designation |
Professor |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Department of Obstetrics and Gynaecology
Room no 9
Ernakulam KERALA 682311 India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Preetha George |
| Designation |
Professor |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Department of obstetrics and Gynaecology.
Unit 2
Room No 9 KOOTTALIL HOUSE
KUNNACKAL P O
MUVATTUPUZHA
ERNAKULAM Ernakulam KERALA 682311 India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Preetha George |
| Designation |
Professor |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Department of Obstetrics and Gynaecology.
Unit 2
Ernakulam KERALA 682311 India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malankara Orthodox Syrian Church Medical College, Kolenchery |
|
|
Primary Sponsor
|
| Name |
Malankara Orthodox Syrian Church Medical College |
| Address |
Malankara Orthodox Syrian Church Medical College
Kolenchery p.o, 682311
Ernakulam |
| 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 |
| Dr Ann Mariam Abraham |
Malankara Orthodox Syrian Church Medical College, |
Department of Obstetrics and Gynaecology,
Room no 10 Ernakulam KERALA |
9778211902
annmariam02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Malankara Orthodox Syrian Church Medical College, Kolenchery |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induction of labour using concurrent foleys catheter and oral misoprostol. |
Clinical and demographic data is recorded.
Favourability of cervix assessed with modified bishop’s score.
For the concurrent group, foley’s catheter and oral misoprostol administration done on the same day
|
| Comparator Agent |
Induction of labour using sequential foleys catheter and oral misoprostol. |
Clinical and demographic data is recorded. Favourability of cervix assessed with modified bishop’s score. For the sequential group, foley’s catheter is introduced in the first day and oral misoprostol administration done on the next day. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
primigravida, full term singleton pregnancy, cephalic presentation ,intact membranes, reactive NST, modified bishop’s score less than 6,no other complications. |
|
| ExclusionCriteria |
| Details |
previous uterine scar, rupture of membranes, placenta previa , intrauterine foetal death, latex allergy, presence of contraindications to vaginal delivery. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
comparison of induction to delivery time interval between two groups
|
baseline and 1 week, 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vaginal delivery within 24 hours
|
1 week |
Number of doses needed to induce labour
|
1 week |
Need of oxytocin for augmentation of labour
|
1 week |
Cesarean section rate
|
1 week |
Maternal complications-Post partum pyrexia, Postpartum hemorrhage.
|
6 weeks |
Neonatal complications-APGAR score, Admission in NICU, Meconium stained amniotic fluid.
|
1 week |
Abnormalities in uterine contractility like uterine hypertonus, uterine tachysystole, uterine hyperstimulation
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="192" Sample Size from India="192"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0" Months="6" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [annmariam02@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 02-02-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Induction of labour is
a widely used obstetric intervention, occurring in one in four pregnancies.
When the cervix is unfavorable, different induction methods
are used. Recently with steadily increasing rates of
induction , implementing effective and safe procedures at proper gestation of
pregnancy can significantly decrease maternal and foetal complications.
Different mechanical and medical methods are used to induce labour, but all of
the existing methods are associated with medical risks. Therefore, while
choosing labour induction method, numerous aspects like cost
effectiveness, safety, and rate of operative delivery should be considered.
An informed consent will be taken. Consenting eligible women are
enrolled in the study and randomized to either concurrent or sequential use of
oral misoprostol and foley’s catheter. Clinical and demographic data is
recorded. Favourability of cervix assessed with modified bishop’s score.
For the concurrent group, foley’s catheter and oral misoprostol
administration done on the same day . For the sequential group,
foley’s catheter is introduced in the first day and oral misoprostol
administration done on the next day. We compare primary outcome which
is Induction to delivery interval and secondary outcomes such as
vaginal delivery within 24 hours, number of doses needed to
induce labour, need of oxytocin for augmentation of labour,
caesarean section rate, maternal complications, neonatal
complications and abnormalities in uterine contractility |