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โ† Trials
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Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Diphenhydramine
  • Placebo
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Where

1 site
Gender Wellness OB/GYN
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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