Clinical trial NCT06696573: Effectiveness of Anti-Inflammatory Drugs for Preventing Pain Versus Treating Pain During Medical Abortion From 13 to 22 Weeks at Hung Vuong Hospital
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Management
Anti-Inflammatory Agents, Non-Steroidal
Abortion, Spontaneous
Lead sponsor: Hung Vuong Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two arms: one group receiving prophylactic NSAIDs before the onset of pain during medical abortion and another group receiving NSAIDs on-demand. The study aims to compare the efficacy, safety, and overall pain management outcomes of the two strategies.
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
References: