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Comparison of 2 methods for dilation of cervix four hours before operative hysteroscopy - Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S).

Comparison of Efficacy of Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S) for Cervical Preparation four hours before Operative Hysteroscopy: A Double Blinded Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093028
Enrollment
64
Registered
2025-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: use of synthetic osmotic dilator ( dilapan-s ) 4 hours prior to operative hysteroscopy for cervical dilation.: Synthetic osmotic dilators may be more effective in achieving optimal cerv

Sponsors

JIPMER
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: i. Known Cervical incompetence ii. Contraindication to Misoprostol use like history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure iii. Significant uterovaginal prolapse precluding the administration of vaginal tablets. iv. Active vaginal infection or active pelvic inflammatory disease

Design outcomes

Primary

MeasureTime frame
To compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation 4hrs prior to operative hysteroscopy.Timepoint: During the insertion of 26 F resectoscope-operative hysteroscope AT 4 HOURS - following vaginal misoprostol or synthetic osmotic dilator dilapan S

Secondary

MeasureTime frame
To study the side effects & complications of Misoprostol & short term use of synthetic osmotic dilator (Dilapan).Timepoint: during 4 HOURS The time period after inserting the drug or medical device to before shifting the patient to the operation theatre

Countries

India

Contacts

Public ContactDr Murali Subbaiah

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