Lactation Suppressed, Second Trimester Abortion
Conditions
Brief summary
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called cabergoline which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.
Interventions
DRUGCabergoline
1mg oral cabergoline given to participants once
DRUGPlacebo
1 encapsulated placebo tablet given to participants after procedure
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises * ages 18 to 50 * con provide informed consent in English
Exclusion criteria
* Age under 18 or above 50 * gestational ages before 16 weeks 0 days or after 20 weeks 0 days * unable to provide written consent in English * hypertensive disorder * uncontrolled hypertension or known hypersensitivity to ergot derivatives * History of cardiac valvular disorders * history of pulmonary fibrosis * documented bipolar schizophrenia * documented allergy to medication, including lactose intolerance (placebo pill involves lactose)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast symptoms | 3 days post procedure and two weeks post procedure | Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc). |
Countries
United States
Outcome results
None listed