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Comparison of the Effect of Misoprostol With and Without Evening Primrose in Therapeutic Abortion

Comparison of the Effect of Misoprostol With and Without Evening Primrose in Therapeutic Abortion: A Randomized Double-Blind Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250225064853N1
Enrollment
100
Registered
2025-03-02
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Therapeutic Abortion. (Induced) termination of pregnancy with unspecified complications

Interventions

Intervention 1: Intervention Group 1: Misoprostol Combined with Evening Primrose OilTreatment Method:In this group, a combination of misoprostol and evening primrose oil is used.Misoprostol:Dose: 200

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 40 years Candidate for therapeutic abortion (based on the specialist’s evaluation) Gestational age less than 20 weeks No contraindications for Misoprostol or Evening Primrose (e.g., patients with respiratory diseases or asthma are excluded) Providing informed consent to participate in the study Availability for follow-up and monitoring

Exclusion criteria

Exclusion criteria: Participants who do not provide consent to participate in the study. Participants who are lost to follow-up during the study Patients with contraindications to receiving evening primrose oil or misoprostol, such as those with pulmonary diseases or asthma

Design outcomes

Primary

MeasureTime frame
Success rate of pregnancy termination Definition: The percentage of patients who achieve complete pregnancy termination with the assigned treatment (Misoprostol alone or Misoprostol with Evening Primrose), without the need for additional interventions (e.g., curettage). Timepoint: 24 to 48 hours after the start of treatment. Method of measurement: Percentage (%).

Secondary

MeasureTime frame
Time required for pregnancy termination Definition: The duration from the start of treatment to the complete termination of pregnancy (complete expulsion of pregnancy products). Timepoint: From the start of treatment until pregnancy termination. Method of measurement: Hours.;Need for additional intervention Definition: The number of patients requiring additional interventions (e.g., curettage or surgery) after treatment. Timepoint: Within 7 days after the start of treatment. Method of measurement: Number (n).;Patient satisfaction Definition: The level of patient satisfaction with the treatment method, assessed using a standardized questionnaire. Timepoint: After completing the treatment. Method of measurement: Score (Scale 1-10).;Rate of side effects Definition: The percentage of patients experiencing treatment-related side effects (e.g., nausea, vomiting, diarrhea, or severe bleeding). Timepoint: Within 72 hours after the start of treatment. Method of measurement: Percentage (%).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzar Danesh Shahraki

Esfahan University of Medical Sciences

danesh@med.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

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