Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06696573

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

Led by Le Thi Kieu Trang · Updated on 2025-03-13

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) for preventing pain compared to treating pain as it occurs during medical abortion for pregnancies between 13 and 22 weeks at Hung Vuong Hospital. The study seeks to determine whether taking NSAIDs proactively reduces pain better than using them only when pain starts and to assess any possible side effects of NSAID use in this setting. Participants will be randomly assigned to one of two groups: one receiving prophylactic NSAID treatment before pain begins, typically using oral tablets like 400 mg Ibuprofen, and the other receiving NSAIDs on demand when pain is reported. The medication dosing and frequency will be adjusted according to the clinical protocol and participant response, with careful monitoring of pain levels, safety, and overall satisfaction during the abortion process. During the study, participants will have their pain assessed using validated scales and will be observed for any adverse reactions to the medication. Researchers will collect data from the start of the medical abortion until its completion, focusing on comparing pain relief effectiveness and safety between the two approaches. The total participation duration aligns with the abortion procedure period and related assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 years or older
  • No mental illness
  • Gestational age between 13 and 22 weeks based on last menstrual period or first-trimester ultrasound
  • Indication for stillbirth, fetal malformation requiring termination, or voluntary abortion with counseling and understanding
  • Willing to participate in the study
  • Able to read and sign informed consent
  • Able to provide personal information independently
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From initiation of medical abortion treatment through abortion completion

Participants receive either prophylactic or on-demand non-steroidal anti-inflammatory drugs (NSAIDs) to manage pain during the medical abortion process between 13 and 22 weeks of pregnancy. The medication is taken orally with dosage and frequency adjusted according to clinical protocol and participant needs to reduce pain intensity throughout the procedure.

Visits as needed during medical abortion procedure

Trial Site Locations

Total: 1 location

1

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Actively Recruiting

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Research Team

L

Le Trang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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