Effectiveness of Anti-Inflammatory Drugs for Preventing Pain Versus Treating Pain During Medical Abortion From 13 to 22 Weeks at Hung Vuong Hospital

Last updated: March 10, 2025
Sponsor: Le Thi Kieu Trang
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

On-Demand NSAID Administration

Prophylactic NSAID Administration

Clinical Study ID

NCT06696573
Hung Vuong Hospital
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to assess the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) for prophylactic pain relief compared to on-demand pain relief during medical abortion for pregnancies between 13 and 22 weeks at Hung Vuong Hospital in Ho Chi Minh City. The main questions it aims to answer are:

  1. Does prophylactic use of NSAIDs reduce pain compared to on-demand use during medical abortion?

  2. What are the potential adverse effects of NSAIDs in this context?

Researchers will compare a group receiving prophylactic NSAIDs to a control group receiving on-demand pain relief to determine if the prophylactic approach leads to improved pain management outcomes.

Participants will:

  • Be given NSAIDs either as a preventative measure or upon the onset of pain.

  • Be monitored for pain levels using validated pain scales, any side effects, and outcomes of the abortion procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women aged 18 years or older.

  • No mental illness.

  • Gestational age between 13 and 22 weeks (based on the last menstrual period with aregular menstrual cycle and accurate recall of the last menstrual period, or basedon a first-trimester ultrasound) with an indication of stillbirth, fetalmalformation requiring termination, or voluntary abortion with counseling andunderstanding of the abortion procedure.

  • Willing to participate in the study.

  • Capable of reading and signing the informed consent form.

  • Able to provide personal information independently.

Exclusion

Exclusion Criteria:

  • Medical conditions contraindicating medical abortion: bleeding disorders,anticoagulant use, moderate to severe anemia.

  • Cardiovascular conditions: heart failure, mitral valve stenosis, embolism,uncontrolled hypertension.

  • Other medical conditions: renal failure, adrenal gland disorders, severe asthma,liver and biliary diseases, glaucoma.

  • Active pelvic inflammatory disease or acute genital infections.

  • Previous uterine surgery.

  • Placenta previa or central placenta previa.

  • Uterine malformations.

  • History of allergy to NSAIDs, Mifepristone, or Misoprostol.

  • Unwillingness to participate in the study.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: On-Demand NSAID Administration
Phase:
Study Start date:
December 13, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hung Vuong Hospital

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

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