Effectiveness and Safety of Three Vaginal Agents for Cervical Preparation

Comparison of the Effectiveness and Safety of Vaginal Misoprostol, Evening Primrose Oil, and Hyoscine Butyl bromide for Cervical Preparation Before Hysteroscopy D&C: Multicentric Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250122064473N1

Enrollment

249

Registered

2026-04-12

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Cervical Ripening and Dilatation. Encounter for preprocedural laboratory examination

Interventions

Intervention 1: Intervention Group 1: A vaginal dose of 20 mg of Hyoscine Butylbromide (manufactured by Jalinous Pharmaceutical Co.) is administered. This medication is placed in the posterior vaginal

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: age 18-75 years elective or diagnostic Hysteroscopy and D&C candidates closed cervix

Exclusion criteria

Exclusion criteria: Lack of patient consent History of cervical surgery Anatomical stenosis Uterine anomaly Hypersensitivity to prostaglandins Severe asthma Glaucoma Myasthenia gravis Epilepsy Coagulation disorder

Design outcomes

Primary

Measure	Time frame
Initial cervical dilation. Timepoint: Four hours after medication administration. Method of measurement: Hegar dilator.;Successful Hysteroscopic Entry. Timepoint: Four hours after medication administration. Method of measurement: hysteroscope.	—

Secondary

Measure	Time frame
Duration required for cervical dilation. Timepoint: 4 hours after medication administration. Method of measurement: Measured by a data recorder using a chronometer.;Medication side effects: Presence of nausea, vomiting, diarrhea, fever (>38°C), chills, or abdominal cramping. Timepoint: 24 hours after receiving intervention. Method of measurement: Patient interview and standard checklist.;Post-procedural pain intensity. Timepoint: One hour after receiving the intervention. Method of measurement: Numeric Rating Scale (NRS) 0-10.;Intra-procedural complications: Incidence of cervical laceration or uterine perforation. Timepoint: During the surgical procedure. Method of measurement: Observation and surgical report by the surgeon.	—

Measure

Time frame

Duration required for cervical dilation. Timepoint: 4 hours after medication administration. Method of measurement: Measured by a data recorder using a chronometer.;Medication side effects: Presence of nausea, vomiting, diarrhea, fever (>38°C), chills, or abdominal cramping. Timepoint: 24 hours after receiving intervention. Method of measurement: Patient interview and standard checklist.;Post-procedural pain intensity. Timepoint: One hour after receiving the intervention. Method of measurement: Numeric Rating Scale (NRS) 0-10.;Intra-procedural complications: Incidence of cervical laceration or uterine perforation. Timepoint: During the surgical procedure. Method of measurement: Observation and surgical report by the surgeon.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Katebi Koushali

Shahid Beheshti University of Medical Sciences

Katebif@ymail.com+98 21 2271 8000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026