Diphenhydramine added to standard sedation for first-trimester abortion
Official title: Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Run by University of Rochester · NCT07542730 · Data updated 2026-11-12
This trial tests whether giving diphenhydramine with standard moderate sedation improves pain control during first-trimester uterine aspiration for adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 98 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | June 29, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07542730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ undergoing first-trimester uterine aspiration (≤13 weeks) seeking moderate sedation and meeting safety criteria.
✕Probably not a fit
Those who do not respond to diphenhydramine or have no added pain relief from the adjunct may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, double-blind, randomized, placebo-controlled study at the University of Rochester Family Planning Clinic and Strong Memorial Hospital. Adults undergoing first-trimester uterine aspiration (≤13 weeks) are randomized 1:1 to receive either intravenous diphenhydramine 50 mg or placebo in addition to standard moderate sedation with midazolam and fentanyl. Pain is measured with a 100 mm visual analog scale at multiple peri-procedural time points, and sedation depth is assessed with a sedation scale; additional outcomes include total sedative dose, time to discharge, and adverse events. The goal is to determine if diphenhydramine as an adjunct reduces procedural pain and improves patient experience.
Why it matters
Potential benefit: If successful, patients may experience less pain and smoother recovery during early pregnancy procedures.
How similar studies have gone: Previous work in adjunctive medications for sedation has shown potential benefits in pain control, but this specific diphenhydramine addition is a novel approach within this procedure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 it's running
-
Gender Wellness OB/GYN
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Sarah Cavegila, MPH
- Email: Sarah_Caveglia@URMC.Rochester.edu
- Phone: 585-273-5734
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.