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Comparing a vaginal tablet (Misoprostol) and device (Dilapan) kept inside the cervix for dilatation of cervix before operative hysterosocpic procedures

Comparison of effectiveness of vaginal Misoprostol and synthetic osmotic dilator (Dilapan) for cervical preparation prior to operative hysteroscopy: a double blinded randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024844
Enrollment
50
Registered
2020-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N99- Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified

Interventions

Intervention1: Cervical dilatation using synthetic osmotic dilator(Dilapan): After obtaining informed consent, cervical osmotic dilator (maximum of upto 2) will be inserted intracervically 12 hours pr

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women of age 18 years or more, scheduled for operative hysteroscopic procedures with 26F resectoscope

Exclusion criteria

Exclusion criteria: Cervical incompetence Contraindication to Misoprostol use like history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure Significant uterovaginal prolapse precluding the administration of vaginal tablets. Pelvic inflammatory disease

Design outcomes

Primary

MeasureTime frame
The need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation prior to operative hysteroscopy. Timepoint: 12 hours after insertion—

Secondary

MeasureTime frame
The side effects and complications of Misoprostol and synthetic osmotic dilator (Dilapan) Timepoint: 3 weeks—

Countries

India

Contacts

Public ContactAiswarya K Nair

Jawaharlal Institute Of Postgraduate Medical Education And Research

muralidraiims@gmail.com8940760837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026