Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Recruiting now Phase 4 NCT07542730
Run by University of Rochester · for 18 and older · Women
What this study is about
This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.
Who can join (things the study team will check)
✅ You may be able to join if…
- Adults age 18 years and older
- Desire procedural abortion with moderate sedation
- Gestational age less than or equal to 13 weeks
- Intrauterine pregnancy or pregnancy of unknown location
- Body mass index less than or equal to 40
🚫 You may not be able to join if…
- Desire medical abortion or desire to continue pregnancy
- Gestational age greater than 13 weeks
- Body mass index greater than 40
- Age younger than 18 years
- Confirmed ectopic pregnancy
- Medical condition that is a contraindication to moderate sedation as determined by the treating clinician
Where this trial is running
- Gender Wellness OB/GYN, Rochester, New York, United States
Who to contact
Sarah Cavegila, MPH · 585-273-5734 · Sarah_Caveglia@URMC.Rochester.edu
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07542730.
Verify everything on the official ClinicalTrials.gov record. Page updated September 2026.