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Comparison of two routes of a drug before hysteroscopy to make the procedure easier

Sublingual vs vaginal misoprostol for cervical ripening before diagnostic hysteroscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012444
Enrollment
138
Registered
2018-03-09
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: null- Premenopausal women planned for hysteroscopy for indications like abnormal uterine bleeding , primary subfertility , missed intra uterine copper device.

Interventions

Intervention1: SUBLINGUAL MISOPROSTOL: 400 MICROGRAM OF SUBLINGUAL MISOPROSTOL GIVEN 4 HOURS BEFORE DIAGNOSTIC HYSTEROSCOPY Intervention2: SUBLINGUAL MISOPROSTOL: 400 MICROGRAM SUBLINGUAL MISOPROSTOL

Sponsors

Nil Ratan Sircar medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Married women over 18 years who were symptomatic and were suspected of having intrauterine pathology such as submucosal myoma ,endometrial polyp, missed intrauterine copper device or other endometrial pathological findings based on transvaginal ultrasound were enrolled for diagnostic hysteroscopy.

Exclusion criteria

Exclusion criteria: 1)Pregnancy, 2)Postmenopausal women 3)Evidence of allergy to prostaglandins 4)Signs of genital infection 5)History of cervical surgery 6) Endometrial lesions with suspected endo or exocervical lesions 7)Suspected malignancy that could affect the cervical resistance 8)Medical disorders such as bronchial asthma , irritable bowel syndrome and cardiovascular disease

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was the initial cervical dilatation in mm measured by the most appropriately negotiable Hegar dilator.Timepoint: At the time of intervention.

Secondary

MeasureTime frame
Time required for cervical dilatation for smooth introduction of hysteroscope using a stopwatch,Percentage of cases having initial cervical dilatation â?¥ 5 mm, Percentage of complications â?? bleeding , fever , diarrhea ,nausea and vomiting , pelvic pain , rigor , and cervical injury. Timepoint: During procedure and one week thereafter

Countries

India

Contacts

Public ContactRitisha Basu

Nil Ratan Sircar Medical College and Hospital, Kolkata

picklu.chaudhuri@gmail.com8240097694

Outcome results

None listed

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