| Methods |
Randomized double‐blind, placebo‐controlled trial. Randomization per computer generated list of random numbers. Allocation with sequentially numbered opaque envelopes. Power analysis done. A difference of 1.5 was chosen to be clinically important.
Urban free‐standing urban abortion clinic in British Columbia, Canada. Study length: July 2000 to November 2001. |
| Participants |
104 pregnant women. Gestational age equal to or less than 14wks. Mean maternal age 25‐27.
Excluded women who were unable to understand or unwilling to sign consent form. Allergy to lorazepam. |
| Interventions |
Group 1: 1mg lorazepam orally
Group 2: placebo
both given 1 hour prior to vacuum aspiration. All participants received local anesthesia. |
| Outcomes |
Anxiety and depression prior to counseling and after counseling. Anxiety and pain during procedure assessed after the procedure. All outcomes were assessed with a 11‐point verbal scale (0 = no pain/no anxiety to 10 = worst pain you can imagine/most anxious you could be). |
| Notes |
Per e‐mail communicaion with Dr. Wiebe: Lorazepam was given orally. No participant 14+0 or more wks of gestational age.
Study also had observational arm with 262 pregnant women, in which patients choosing lorazepam were compared to the group not choosing lorazepam. Mild side effects noted in 3 study subjects. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
