The effect of vaginal hyoscine butyl bromide on cervical ripening before hysteroscopy

Comparison the effect of vaginal hyoscine butyl bromide and vaginal misoprostol on cervical ripening before hysteroscopy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190929044920N1

Enrollment

150

Registered

2019-12-07

Start date

2019-10-23

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

Condition 1: Uterine polyp. Condition 2: endometrial hyperplasia. Condition 3: Submucousal fibroid. Condition 4: Abnormal uterine bleeding. Condition 5: Noninflammatory disorder of uterus, unspecified. Condition 6: Patients who are candidates for hysteroscopy. Polyp of corpus uteri Endometrial hyperplasia Submucous leiomyoma of uterus Abnormal uterine and vaginal bleeding, unspecified Noninflammatory disorder of uterus, unspecified Inflammatory disease of uterus, unspecified

Interventions

Intervention 1: Hyosine Butyl Bromide Recipient: This drug will be given vaginally at a dose of 20 mg (2 tablets 10 mg) 4 hours before surgery. Intervention 2: Misoprostol recipient: This drug will be

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women candidates for hysteroscopy Age between 18-65 years

Exclusion criteria

Exclusion criteria: Dissatisfaction with continuing treatment process Sensitivity to the drugs used Asthma Glaucoma cardiovascular disease Taking antihypertensive drugs Sensitivity to prostaglandins

Design outcomes

Primary

Measure	Time frame
Frequency of Dilator Hagar Crossings No. 5. Timepoint: After complete anesthesia. Method of measurement: Hagar Number Five Crossing.;Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.;Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.;Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS) zero to ten.;Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.	—

Measure

Time frame

Frequency of Dilator Hagar Crossings No. 5. Timepoint: After complete anesthesia. Method of measurement: Hagar Number Five Crossing.;Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.;Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.;Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS) zero to ten.;Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.

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Secondary

Measure	Time frame
Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.;Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.;Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS) zero to ten.;Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.	—

Measure

Time frame

Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.;Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.;Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS) zero to ten.;Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboubeh Borna

Zahedan University of Medical Sciences

dr.bornamah@zaums.ac.ir+98 54 3329 5570

Outcome results

None listed

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