©2024 Stanford Medicine
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss
Recruiting
Trial ID: NCT06029673
Purpose
Breast pain following second-trimester abortion is common. Breast engorgement and milk
leakage following second-trimester perinatal loss and abortion can cause both physical pain
and emotional distress. Dopamine agonists have previously been shown to be effective in
lactation inhibition for third-trimester fetal/neonatal loss or contraindications to
breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single
dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28
weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to
determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
Official Title
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial
Stanford Investigator(s)
Kate Shaw, MD MS
Associate Professor of Obstetrics and Gynecology
Andrea Henkel
Clinical Assistant Professor, Obstetrics & Gynecology
Eligibility
Inclusion Criteria:
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 16/0-19/6 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
- Able to consent for a research study, literate in English or Spanish
- Willing to comply with study procedures and follow-up
- Access to smart phone throughout study
Exclusion Criteria:
18 Years Female No No
Inclusion Criteria:
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating
performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion or undergoing induction for demise
- English or Spanish speaking
- Able to consent for a research study, literate in English or Spanish
- Willing to comply with study procedures and follow-up
- Access to smart phone throughout study
Exclusion Criteria:
- 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)
- Uncontrolled hypertension - defined as baseline BP > 160/110, or chronic hypertension
requiring more than one baseline medication, or current pregnancy-induced hypertension
spectrum disorders (gestational hypertension, preeclampsia, eclampsia)
- History of cardiac valvular disorders or valvular repair
- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
Intervention(s):
drug: Cabergoline 1 MG
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305