Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss
Launched by STANFORD UNIVERSITY · Sep 1, 2023
Trial Information
Current as of July 01, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast sympto...
Gender
FEMALE
Eligibility criteria
- 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
About Stanford University
Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stanford, California, United States
San Jose, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported