Using pain and nausea medications to improve medical abortion experience
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
EARLY_PHASE1 · Hackensack Meridian Health · NCT05819619
This study is testing if giving women pain and nausea medications before or when they start feeling symptoms during a medical abortion can make the experience easier and more comfortable.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Hackensack Meridian Health (other) |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT05819619 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the effectiveness of prophylactic administration of ondansetron and ibuprofen to reduce nausea and pain associated with medical abortion in women up to 70 days gestational age. Participants will receive these medications either before or at the onset of symptoms following misoprostol administration. The study aims to assess the impact of this regimen on patient satisfaction and overall experience during the medical abortion process.
Who should consider this trial
Good fit: Ideal candidates are healthy, English-speaking women undergoing a medical abortion for voluntary interruption of pregnancy or missed abortion, with a gestational age of 70 days or less.
Not a fit: Patients with chronic medical conditions, known allergies to the study medications, or those requiring surgical management after a failed medical abortion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient comfort and satisfaction during medical abortion procedures.
How similar studies have performed: While similar approaches have been explored, this specific prophylactic regimen for medical abortion is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy * English speaking * female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion * Gestational age \</= 70 days confirmed via ultrasound * Access to a time keeping device * Willingness to complete a telephone or in-clinic follow up Exclusion Criteria: * chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage * Failed medical abortion resulting in surgical management * Known intrauterine infection * Known allergy to ondansetron or ibuprofen * Subjects chronically receiving analgesic drugs * Subjects unable to give consent * Subjects taking medications that interact with ondansetron or ibuprofen
Where this trial is running
Hackensack, New Jersey
- Antonia Oladipo — Hackensack, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Melissa Figueroa, MD — Hackensack Meridian Health
- Study coordinator: Antonia Oladipo, MD
- Email: antonia.oladipo@hmhn.org
- Phone: 5519962765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nausea, Pain, medical abortion, prophylactic use, nausea, pain, patient satisfaction