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Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

RecruitingPhase 4

Who can join

Ages 18 and older · Women

Full eligibility 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

About the study

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.

What is being tested

Sponsor: University of Rochester · Participants: 98 · Started: Jun 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07542730

Locations in the U.S.

New YorkGender Wellness OB/GYN, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.