Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss

Trial ID or NCT#

NCT06029673

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. 18 Years Female No No
    1. Inclusion Criteria:
      1. * 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
    2. Exclusion Criteria:
      1. * 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
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Investigator(s)

Andrea Henkel
Andrea Henkel
Obstetrician and Gynecologist (OB-GYN), Family planning specialist
Clinical Assistant Professor, Obstetrics & Gynecology
Kate Shaw, MD MS
Kate Shaw, MD MS
Family planning specialist, Gynecologist, Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology & Gynecologic Specialties/Complex Family Planning)

View on ClinicalTrials.gov