Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy

Comparative Study Between Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy

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

Study Overview

• Status: Completed
• Conditions: Hysteroscopy; Cervical Preparation; Misoprostol; Evening Primorose Oil
• Intervention / Treatment: Other: Primorose Oil; Other: Misoprostol

Detailed Description

Hysteroscopy is an operative procedure in which the gynaecologist directly examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix.

Misoprostol is a synthetic Prostaglandins (PGE1) analogue that has been found to be a safe and inexpensive agent for cervical ripening. It is one of the most studied cervical ripening agents used prior to hysteroscopy.

Evening primrose oil is derived from the seeds of the evening primrose (Oenothera biennis) plant. It is rich in the essential fatty acid gamma linolenic acid, a fatty acid that the body converts to a hormone like substance called prostaglandin E1.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients received evening Primorose Oil.	Other: Primorose Oil; Patients received evening Primorose Oil.
Experimental: Group II; Patients received Misoprostol.	Other: Misoprostol; Patients received Misoprostol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Bleeding	Occurrence of cervical bleeding during cervical entry was recorded.	During operative hysteroscopy (2 hours after vaginal administration of the study medication)
False Passage Formation	Occurrence of false passage during cervical instrumentation was recorded.	During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Cervical Laceration	Occurrence of cervical laceration during cervical dilatation was recorded.	During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Incidence of drug-related adverse effects	Incidence of drug-related adverse effects such as the occurrence of nausea, vomiting, diarrhea, fever, and severe abdominal pain were recorded.	Until completion of the procedure (Up to 2 hours)

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): May 21, 2026
• Study Completion (Actual): May 21, 2026

Study Registration Dates

• First Submitted: June 6, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol
• Other Study ID Numbers: Soh-Med-24-11--7PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No