| CTRI Number |
CTRI/2025/08/092977 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to compare the use of vaginal misoprostol and transcervical foleys catheter vs misoprostol alone in nulliparous women at 40 weeks for induction of labor |
|
Scientific Title of Study
|
A Randomised Controlled Trial Comparing Transcervical foleys catheter with vaginal misoprostol vs Vaginal misoprostol alone in Nulliparous Pregnant women at 40 weeks. |
| 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 Arzoo |
| Designation |
Junior Resident |
| Affiliation |
Dr.Radhakrishnan Medical College |
| Address |
Room no.404 , Dr Radhakrishnan Medical College, Hamirpur ,Himachal Pradesh.
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
8168016300 |
| Fax |
|
| Email |
arzoogarg795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Radhakrishnan Medical College |
| Address |
Room no.402 , Dr .Radhakrishnan Medical College, Hamirpur,Himachal Pradesh
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
7018179737 |
| Fax |
|
| Email |
drsharmasandeep81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Radhakrishnan Medical College |
| Address |
Room no.402 , Dr .Radhakrishnan Medical College, Hamirpur,Himachal Pradesh
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
7018179737 |
| Fax |
|
| Email |
drsharmasandeep81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Antenatal ward, Dr. Radhakrishnan Government Medical College ,Hamirpur ,Himachal Pradesh,India
Pincode -177001 |
|
|
Primary Sponsor
|
| Name |
Dr Radhakrishnan Government Medical College |
| Address |
Dr. Radhakrishnan Government Medical College, Hamirpur, Himachal Pradesh, India. Pin code -177001 |
| 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 |
| Dr Arzoo |
Dr.Radhakrishnan Government Medical College,Hamirpur |
Room no. 402 ,Antenatal Ward, Dr. Radhakrishnan Government Medical College ,Hamirpur.Pincode-177001
Hamirpur
HIMACHAL PRADESH |
8168016300
arzoogarg795@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Dr Radhakrishnan Government Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the use of TCFC along with vaginal misoprostol with vagina misprostol alone in Nulliparous pregnant women at 40 weeks. |
All the women participating in the study will receive 25 micrograms of vaginal misoprostol after which they randomised into two groups. Group A will be inserted with TCFC with 60 cc of NS .In both groups when cervix becomes favourable i.e bishop score more than equal to 6 , patient will be in active phase of labor and further management will be done as per labor room protocol. |
| Comparator Agent |
To compare the use of Transcervical foleys and vaginal misoprostol with vaginal misoprostol alone in nulliparous pregnant women for induction of labor. |
Group A will be inserted with TCFC with 60 cc of Normal saline along with vaginal misoprostol four hourly maximum five doses until they go into labor. Group B will be inserted with only vaginal misoprostol four hourly maximum five dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Single live intrauterine fetus with cephalic presentation .
Period of gestation more than equal to 40 weeks |
|
| ExclusionCriteria |
| Details |
1. Modified Bishop score more than equal to 6
2. All contraindications to vaginal delivery .eg carcinoma cervix, structural pelvic
abnormalities eg. rachitic pelvis, Cephalopelvic disproportion.
3. Fetal malpresentations.
4. Previous uterine surgery .
5. Multifetal gestation.
6. Antepartum hemorrhage.
7. Intrauterine fetal demise.
8. Allergy to latex.
9. Placenta or vasa previa or cord presentation.
10. Active genital herpes.
11. Contraindications to prostaglandins .eg. Asthma, cardiac disease, known bleeding
disorder, concurrent anticoagulant therapy, pelvic infection, hypersensitivity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Induction delivery interval (defined as time of induction with foleys insertion and vaginal misoprostol to delivery of
fetus) |
From the time of insertion of transcervical foleys and misoprostol to delivery of foetus and will be assessed after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of woman delivered vaginally |
Within 12 to 24 hours of induction |
| Proportion of woman undergoing CS |
After delivery |
| Meconium stained liquor |
Not Applicable |
Proportion of woman with Failed IOL
Neonatal Outcome |
If no contractions or Poor Bishop Score after 5 doses of Misoprostol |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
24/08/2025 |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arzoogarg795@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
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 labor (IOL)
implies stimulation of uterine contractions before the spontaneous onset of
labor, with or without ruptured membranes. It is an intervention
designed for iatrogenic ripening of cervix and to initiate uterine contractions
leading to progressive dilatation and effacement of cervix resulting into birth
of the newborn. It is indicated only when the risks of continuing pregnancy
outweigh the benefits to the mother and the fetus. The goal of IOL is to
achieve vaginal delivery in a safe and timely manner. Methods of IOL presently
in use include various mechanical, pharmacological or a combination of
mechanical and pharmacological. Mechanical
methods include use of various agents such as transcervical foley’s catheter (TCFC),
laminaria tents, synthetic osmotic dilators etc. TCFC is a cheap, readily
available, easy to use and moreover a comparatively painless alternative which affects
changes on various components of the bishop score.. TCFC works through mechanical dilation,
resulting in the release of natural prostaglandins from the cervix. Pharmacological methods
of IOL include agents such as oxytocin, prostaglandins (e.g. Misoprostol i.e.
PGE1 and Dinoprostone i.e. PGE2), mifepristone etc. Prostaglandins ripen the cervix directly
by enzymatic collagen degradation and increase of water content in the extracellular
matrix. It effectively ripens the cervix and also induces uterine contractions.
Its use can result in shorter induction-to-delivery times. The catheters have
several potential advantages over pharmacologic methods. They are relatively
inexpensive, easy to store, and easy to remove when necessary lacks systemic
side effects, reversible and can be used in women with previous CS. Hence, we plan to compare vaginal
misoprostol alone vs TCFC with vaginal misoprostol as an adjunct for IOL in
pregnant women at term.
|