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NCT Number: NCT06696573

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

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.

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Key information

Conditions

Pain Management Abortion, Spontaneous Agnosia Anti-Inflammatory Agents, Non-Steroidal Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location status: Recruiting

Location contact

Trang Le, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

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

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 a regular menstrual cycle and accurate recall of the last menstrual period, or based on a first-trimester ultrasound) with an indication of stillbirth, fetal malformation requiring termination, or voluntary abortion with counseling and understanding 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 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.

Treatment and study plan

Prophylactic NSAID Administration

Drug

Participants in this arm will receive a prophylactic dose of a non-steroidal anti-inflammatory drug (NSAID) prior to the onset of pain during medical abortion procedures for pregnancies between 13 and 22 weeks. The intervention aims to reduce pain intensity throughout the process. The NSAID administration involves a specific dosage and schedule, adhering to safety guidelines and monitored for potential side effects.

On-Demand NSAID Administration

Drug

Participants in this group will receive a non-steroidal anti-inflammatory drug (NSAID), such as Ibuprofen, in oral tablet form at a dose of 400 mg. The drug will be administered as needed when participants report experiencing pain during the medical abortion process for pregnancies between 13 and 22 weeks. The goal of this intervention is to provide pain relief in response to individual needs, with administration and dosage adjusted as clinically indicated. Monitoring will occur to assess the efficacy, safety, and patient response to the on-demand approach.

Primary outcomes

  1. Comparing the Effectiveness of Prophylactic NSAID Pain Relief Versus On-Demand Treatment in Cases of Medical Abortion Indicated for Gestational Age 13 to 22 Weeks at Hung Vuong Hospital

    Time frame: Data will be collected from the initiation of medical abortion treatment through abortion completed

    Change in pain scores measured using the Visual Analog Scale (VAS) in millimeters, assessed from baseline to the end of treatment during medical abortion procedures for gestational ages between 13 to 22 weeks. Pain levels will be recorded at regular intervals during and after the administration of prophylactic versus on-demand NSAID treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Le Trang, MD

CONTACT

[email protected]

+8434615919

Sponsors and collaborators

Lead sponsor

Le Thi Kieu Trang

Other

Registry information

Official study title

Effectiveness of Proactive Versus On-Demand Pain Relief With Non-Steroidal Anti-Inflammatory Drugs During Medical Abortion at 13 to 22 Weeks at Hung Vuong Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Mar 13, 2025

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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