| CTRI Number |
CTRI/2026/02/103346 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF MODIFIED WURM AND MCDONALD TECHNIQUE OF TRANSVAGINAL CERVICAL CERCLAGE FOR CERVICAL INSUFFICIENCY |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF: MODIFIED WURM VS MCDONALD TECHNIQUE OF TRANSVAGINAL CERVICAL CERCLAGE FOR CERVICAL INSUFFICIENCY |
| 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 Jui Patil |
| Designation |
OBGY Junior resident (post graduate) |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
OBG OPD 2 Shri B M Patil Medical College, Hospital and Research Centre, bangaramma sajjan campus, solapur road, vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
09769632922 |
| Fax |
|
| Email |
patiljui5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Shiragur |
| Designation |
Professor in the Department of OBGY |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
OBG OPD 2 Shri B M Patil Medical College, Hospital and Research Centre, bangaramma sajjan campus, solapur road, vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shibha.shiragur@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jui Patil |
| Designation |
OBGY Junior resident (post graduate) |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
OBG OPD 2 Shri B M Patil Medical College, Hospital and Research Centre, bangaramma sajjan campus, solapur road, vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
09769632922 |
| Fax |
|
| Email |
patiljui5@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG OPD 2 Shri B M Patil Medical College, Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Jui Patil |
| Address |
OBG OPD 2 Shri B M Patil Medical College, Hospital and Research Centre, bangaramma sajjan campus, solapur road, vijayapura |
| 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 Jui Patil |
Shri B M Patil Medical College, Hospital and Research Centre |
OBG OPD 2 , bangaramma sajjan campus, solapur road, vijayapura
Bijapur
KARNATAKA |
09769632922
patiljui5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
McDonald technique of Transvaginal cervical cerclage |
McDonald technique where a non absorbable suture placed submucosally around the cervix at the level of interval os in a purse string fashion |
| Comparator Agent |
MODIFIED WURM TECHNIQUE OF TRANSVAGINAL CERCLAGE |
MODIFIED WURM IS A TRANSVAGINAL CERCLAGE TECHNIQUE WHERE A NON ABSORBABLE SUTURE PLACED SUBMUCOSALLY AROUND THE CERVIX AT 12,3,6,9 O CLOCK POSITION |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
CERVICAL INSUFFICIENCY ON TRANSVAGINAL ULTRASOUND
CERVIX LENGTH LESS THAN TWENTY FIVE MM
PREVIOUS HISTORY OF SECOND TRIMESTER PREGNANCY LOSS
PREVIOUS HISTORY OF PRETERM PREGNANCY
PERIOD OF GESTATION MORE THAN FOURTEEN WEEKS
NO ACTIVE INFECTIONS |
|
| ExclusionCriteria |
| Details |
PRETERM PREMATURE RUPTURE OF MEMBRANES
PREVIOUSLY FAILED ENCERCLAGE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate pregnancy outcomes, including preterm birth rates and gestational age at delivery |
Beyond 34 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO COMPARE RATES OF POST PROCEDURE COMPLICATIONS
TO ASSESS SUTURE DURABILITY AND NEED FOR RE INTERVENTION
TO EVALUATE PATIENT COMFORT AND RECOVERY TIME |
AFTER 34 WEEKS OF GESTATION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In 2020 about 13 million infants were born prematurely. Antenatal measures such as aspirin ,vaginal progesterone, smoking cessation and infection treatment can reduce this risk . Cervical cerclage also helps women with short cervix but the optimal technique and suture type remain uncertain. Evidence suggests higher cerclage placement lowers preterm birth risk. This study will compare a modified wurm technique with mcdonald method in women with prior preterm birth and a short cervix, primarily to assess feasibility for future trial |