COMPARATIVE STUDY OF: MODIFIED WURM VS MCDONALD TECHNIQUE OF TRANSVAGINAL CERVICAL CERCLAGE FOR CERVICAL INSUFFICIENCY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- to evaluate pregnancy outcomes, including preterm birth rates and gestational age at delivery
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •PRETERM PREMATURE RUPTURE OF MEMBRANES PREVIOUSLY FAILED ENCERCLAGE.
Outcomes
Primary Outcomes
to evaluate pregnancy outcomes, including preterm birth rates and gestational age at delivery
Time Frame: Beyond 34 weeks of gestation
Secondary Outcomes
- TO COMPARE RATES OF POST PROCEDURE COMPLICATIONS(TO ASSESS SUTURE DURABILITY AND NEED FOR RE INTERVENTION)
Investigators
Dr Jui Patil
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre