Cabergoline Relieved Painful Breast Symptoms After Second-Trimester Pregnancy Loss

— Only 28% of those who received the off-label drug experienced symptoms vs 97% of placebo group

MedicalToday

BALTIMORE -- A single dose of off-label cabergoline following a second-trimester abortion or pregnancy loss relieved patients' breast-related symptoms, a randomized controlled trial showed.

Of those who received 1-mg cabergoline, 27.8% reported any breast symptoms -- including engorgement, milk leakage, tenderness, and need for pain relief -- compared with 97% of those in a placebo group (relative risk [RR] 0.05, 95% CI 0.01-0.33, P<0.001), reported Kate A. Shaw, MD, of Stanford University School of Medicine in Palo Alto, California, during the American College of Obstetricians and Gynecologists (ACOG) annual meeting.

Patients receiving the dopamine agonist -- which is indicated for treating hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas -- also reported significantly lower levels of bother compared with the placebo group (2.8% vs 33.3%, P=0.001).

The study, which was also published in , included the 69 participants who completed a survey on day 4 after an abortion or pregnancy loss at 18-28 weeks' gestation, and these differences noted above persisted through day 14.

"Qualitative data previously showed that [breast symptoms after pregnancy loss] can be quite distressing to patients. Breast engorgement can be a reminder of loss and some people describe the challenge factor found in the motherhood identity with the lactation, given the absence of an infant to feed," Shaw told the ACOG audience.

Breast engorgement occurs in more than half of people following a second-trimester pregnancy loss, according to the researchers.

Shaw recalled a patient telling her, "it was not only the physical pain that bothered me, feeling pain in my breasts and knowing that there was milk and having no child to feed was agonizing."

Non-pharmacologic approaches to managing these symptoms include breast binding, herbal remedies, vitamins, or acupuncture, though research has not shown that these interventions led to a rapid resolution of symptoms.

"Given the current lack of evidence-based interventions to prevent breast symptoms in this population, these findings support routine use of cabergoline after second-trimester abortion or pregnancy loss," Shaw and team concluded in their paper.

Future research should look at using cabergoline in earlier stages of gestation, such as 15 to 16 weeks, based on the physiology of lactogenesis. The researchers also suggested comparing results with 0.5 mg versus 1 mg to see if a half dose is similarly effective.

From April 2021 to June 2022, Shaw and team enrolled 73 pregnant adults at 18-28 weeks' gestation. Participants were seeking abortion care or management of fetal demise; 86.3% underwent a dilation and evacuation procedure. Median gestational age was 21 weeks, and median participant age was 33. A majority of participants were nulliparous (56.2%), and 37.0% had public insurance.

In her presentation, Shaw noted that the demographics of the cohort reflected the population of the surrounding area. In the study, 34.2% self-identified as Hispanic, and 39.7% self-identified as Asian American or Pacific Islander.

All participants received 200 mg of mifepristone (Mifeprex), and those past 22 weeks' gestation received feticidal injection with digoxin.

Participants were randomized 1:1 to cabergoline or placebo. They completed a validated, piloted, electronic survey at baseline and at multiple timepoints through 2 weeks to assess breast symptoms, side effects, and bother.

Loss to follow-up was low, with 94.5% of participants returning the survey information for the primary outcome.

The most common side effects, including constipation, headache, fatigue, and insomnia, did not differ between groups.

Serum prolactin levels were similar at baseline between those who received cabergoline versus placebo. On day 4, these levels were 6.5 ng/mL for those who received cabergoline compared with 18.0 ng/ mL for those receiving placebo (P=0.049).

Study limitations included low trial acceptance. The study was also "underpowered to detect small differences in side effects, lack of gestational age stratification in original randomization scheme, and restricted external validity inherent to a randomized trial," Shaw and team wrote.

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    Rachael Robertson is a writer on the enterprise and investigative team, also covering OB/GYN news. Her print, data, and audio stories have appeared in Everyday Health, Gizmodo, the Bronx Times, and multiple podcasts.

Disclosures

Shaw reported no conflicts of interest. One co-author reported financial ties to GenBioPro.

Primary Source

Obstetrics & Gynecology

Henkel A, et al "Cabergoline for lactation inhibition after second-trimester abortion or pregnancy loss" Obstet Gynecol 2023; DOI: 10.1097/AOG.0000000000005190.