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Hysteroscopy procedure without cervical preparation

Evaluating The Efficacy And Safety Of Hysteroscopic Procedures Without Cervical Priming Compared To Misoprostol Cervical Priming In Premenopausal Women: An Equivalent Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098750
Enrollment
80
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: N719- Inflammatory disease of uterus, unspecified Health Condition 2: N72- Inflammatory disease of cervix uteri Health Condition 3: N840- Polyp of corpus uteri Health Condition 4: N841- Polyp of cervix uteri Health Condition 5: N850- Endometrial hyperplasia Health Condition 6: N856- Intrauterine synechiae Health Condition 7: N857- Hematometra Health Condition 8: N858- Other specified noninflammatory disorders of uterus Health Condition 9: N859- Noninflammatory disorder of ute

Interventions

Intervention1: omittance of ripening agent: omittance of tab misoprostol for cervical ripening prior to hysteroscopic procedures in perimenopausal patients

Sponsors

self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: premenopausal Indicated for diagnostic or Operative hysteroscopy Willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: Allergy to prostaglandins Prior cervical surgery Active pelvic infection Pregnancy Anatomical abnormalities (e.g., cervical stenosis, M llerian anomalies)

Design outcomes

Primary

MeasureTime frame
To evaluate the hysteroscope insertion ease in premenopausal woman undergoing hysteroscopy with or without cervical primingTimepoint: at baseline (during procedure)

Secondary

MeasureTime frame
To assess procedure time (starting from vaginoscopy to entering the uterine cavity) To assess need for cervical dilatation in both groups Timepoint: at baseline (during procedure)

Countries

India

Contacts

Public ContactDr Yogita Satpute

All India Institute of Medical Sciences, Nagpur

dramruta85@aiimsnagpur.edu.in8600031166

Outcome results

None listed

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