Clinical trial NCT06029673: Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss
Official title: Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Lactation Suppressed
Keywords: abortion
fetal demise
lactation
engorgement
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Mar Monte
First posted: 2023-09-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 symptoms compared to the control group.

This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.

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

Primary outcomes:
measure: Number of Participants Reporting Breast Pain
timeFrame: Day 4 after procedure
Secondary outcomes:
measure: Number of Participants Experiencing Side-effects
timeFrame: Cumulative over 2 weeks
measure: Number of Participants Reporting Significant Bother From Breast Pain
timeFrame: Day 4 after procedure
measure: Number of Participants Reporting Significant Bother From Side-effects
timeFrame: Cumulative over 2 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Planned Parenthood - San Jose Central Health Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: