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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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:
- Does prophylactic use of NSAIDs reduce pain compared to on-demand use during medical abortion?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is not applicable as this study is open-label, meaning both participants and care providers are aware of the intervention assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prophylactic NSAID Group for Pain Management in Medical Abortion
Participants in this group will receive a prophylactic administration of a non-steroidal anti-inflammatory drug (NSAID) to manage pain before its onset during the medical abortion process for pregnancies between 13 and 22 weeks. The intervention will involve the use of a generic NSAID (e.g., Ibuprofen), administered in oral tablet form at a specified dosage, such as 400 mg. The medication will be taken prior to the expected onset of uterine contractions and will be monitored for efficacy and safety throughout the duration of the procedure. The administration may be repeated based on the clinical protocol, with an appropriate frequency adjusted according to the needs and response of the participant. The aim is to evaluate pain reduction, overall satisfaction, and any potential side effects or adverse events associated with this prophylactic approach.
干预措施: Prophylactic NSAID Administration (Drug)
On-Demand NSAID Group for Pain Management in Medical Abortion
Participants in this group will receive non-steroidal anti-inflammatory drugs (NSAIDs) on an as-needed basis during the medical abortion process for pregnancies between 13 and 22 weeks. The administration will occur once participants report experiencing pain, with the goal of managing pain symptoms as they arise. The intervention involves a specified dosage of a generic NSAID (e.g., Ibuprofen) in oral tablet form, typically 400 mg, administered as required to control pain. The effectiveness of on-demand NSAID administration will be evaluated in terms of pain relief, safety, and participant satisfaction throughout the procedure.
干预措施: On-Demand NSAID Administration (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
未报告次要终点
研究者
Le Thi Kieu Trang
Doctor
Hung Vuong Hospital