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Completed

NCT Number: NCT07641595

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.

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Key information

Conditions

Evening Primorose Oil Cervical Preparation Hysteroscopy Misoprostol

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, 82511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primorose Oil

Other

Patients received evening Primorose Oil.

Misoprostol

Other

Patients received Misoprostol.

Primary outcomes

  1. Assessment of cervical Ripening

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

    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.

Secondary outcomes

  1. Cervical Bleeding

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

    Occurrence of cervical bleeding during cervical entry was recorded.

  2. False Passage Formation

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

    Occurrence of false passage during cervical instrumentation was recorded.

  3. Cervical Laceration

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

    Occurrence of cervical laceration during cervical dilatation was recorded.

  4. Incidence of drug-related adverse effects

    Time frame: Until completion of the procedure (Up to 2 hours)

    Incidence of drug-related adverse effects such as the occurrence of nausea, vomiting, diarrhea, fever, and severe abdominal pain were recorded.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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