About this trial
Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. This study seeks to determine if investigators can more precisely manage these patients with a reduced dose appropriate for the physiology of the second trimester, thereby reducing the medication cost and reducing or eliminating the uncomfortable medication side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant people, ages 18 years or older
Intrauterine pregnancy between 16/0-25/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
Consented for an induced, elective abortion or undergoing management of fetal demise
English or Spanish speaking
Disqualifiers
Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
Currently breastfeeding
Currently receiving dopamine agonist or antagonist therapy for other indication leg syndrome)
Contraindication to cabergoline (as per package insert)
Trial design
Parallel
Treatments tested in this trial
Cabergoline
DrugCabergoline
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with serum prolactin level less than 23 ng/mL
Comparison of the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level (defined as less than 23ng/mL) to those receiving cabergoline 1 mg
Secondary outcomes
Number of participants with breast symptoms
Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: