RecruitingNot Applicable

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

Vietnam180 participantsStarted 2024-12-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT06696573

SponsorLe Thi Kieu Trang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Le Trang, MD

+8434615919 lethikieutrang912@gmail.com

View on ClinicalTrials.gov More Pain Management trials