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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Abortion, Spontaneous; Anti-Inflammatory Agents, Non-Steroidal
• Intervention / Treatment: Drug: Prophylactic NSAID Administration; Drug: On-Demand NSAID Administration

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Le Trang, MD; Phone Number: +8434615919; Email: lethikieutrang912@gmail.com

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Hung Vuong Hospital
    • Contact: Trang Le, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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 efficacy, safety, and patient response to the on-demand approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Data will be collected from the initiation of medical abortion treatment through abortion completed

Collaborators and Investigators

• Sponsor: Le Thi Kieu Trang

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: Hung Vuong Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No