Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Recruiting · NCT07542730 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
DiphenhydraminePlacebo
What this trial 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 take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Gender Wellness OB/GYN - Rochester, New York, United States