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Recruiting NCT06696573

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

No phase Interventional Pain Management Anti-Inflammatory Agents, Non-Steroidal Abortion, Spontaneous

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prophylactic NSAID Administration, On-Demand NSAID Administration.
Who it may be relevant to
Registry conditions: Pain Management, Anti-Inflammatory Agents, Non-Steroidal, Abortion, Spontaneous. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Prophylactic NSAID Administration
    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.
  • Drug On-Demand NSAID Administration
    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 ef

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Hung Vuong Hospital — Ho Chi Minh City

Identifiers

NCT: NCT06696573 · Hung Vuong Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗