Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy

NCT07641595 | Completed

• 1 other identifier: Soh-Med-24-11--7PD
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy.

Conditions

Evening Primorose Oil; Misoprostol; Cervical Preparation; Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Assessment of cervical Ripening

  Cervical ripening assessed by the interval between insertion of Hegar dilators size 3 and size 10, and by the size of the first Hegar dilator requiring forceful insertion.

  During operative hysteroscopy (2 hours after vaginal administration of the study medication)

Secondary Outcomes (4)

• Cervical Bleeding

  During operative hysteroscopy (2 hours after vaginal administration of the study medication)

• False Passage Formation

  During operative hysteroscopy (2 hours after vaginal administration of the study medication)

• Cervical Laceration

  During operative hysteroscopy (2 hours after vaginal administration of the study medication)

• Incidence of drug-related adverse effects

  Until completion of the procedure (Up to 2 hours)

Study Arms (2)

Group I

EXPERIMENTAL

Patients received evening Primorose Oil.

Other: Primorose Oil

Group II

EXPERIMENTAL

Patients received Misoprostol.

Other: Misoprostol

Interventions

Primorose Oil OTHER

Patients received evening Primorose Oil.

Group I

Misoprostol OTHER

Patients received Misoprostol.

Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women underwent Hysteroscopy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18-65 years
• Patients need operative hysteroscopy

You may not qualify if:

• Pregnant women.
• Incompetent cervix.
• History of cervical operations like conization.
• Contraindications for both drugs (women with bleeding disorders, consumers of anticoagulants, schizophrenic individuals receiving phenothiazine, epileptics and those on medication for antihypertension).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Sohag University, Sohag, Egypt.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 11, 2026
• Study Start: November 12, 2024
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)