Cabergoline Prevents Breast Symptoms After Second-Trimester Abortion or Pregnancy Loss: Study

The study entitled "Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss" is led by Dr Henkel, Andrea MD, MS and colleagues.

In this double-blinded, block-randomized superiority trial, researchers assessed Cabergoline's efficacy at decreasing breast symptoms after second-trimester abortion or pregnancy loss and enrolled pregnant women 18–28 weeks of gestation (English- or Spanish-speaking) and without contraindication to the study drug.

The primary outcomes measured were the breast symptoms a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4.

The study results are:

• One hundred fifty patients were screened, out of which 73 participants were enrolled.
• Baseline demographics were balanced between groups: median gestational age was 21 weeks (range 18–26 weeks), 56.2% of participants were nulliparous, 34.2% self-identified as Hispanic, and 37.0% had public insurance.
• There were similarities in reported breast symptoms at baseline between groups.
• Among 69 participants who returned surveys on day 4, significantly fewer participants receiving Cabergoline reported breast symptoms than placebo, and recording was 27.8% vs 97.0%.
• These differences persisted through day 14.
• There were similarities in Reported incidence and severity of side effects between groups, with constipation, fatigue and headache as the most common.
• There were similarities in Serum prolactin levels at baseline.
• The mean serum prolactin level for those receiving Cabergoline and placebo was 6.5 ng/mL and 18.0 ng/mL, respectively, on day 4

They said, "We selected a dose of 1 mg of cabergoline based on existing formulary options of 0.5 mg tabs and prior dose-finding studies that supported higher efficacy with higher doses."

Concluding further, they said, based on the study results, they find Cabergoline an effective and well-tolerated strategy for preventing breast symptoms after second-trimester abortion or pregnancy loss.

The study strengths were study design, diverse population, questionnaires, and lack of industry sponsorship.

They said our primary outcome was clinically meaningful and person-centred, allowing broad generalizability of results.

However, the study had limitations like low trial acceptance, underpowered to detect minor differences in side effects, lack of gestational age stratification in the original randomization scheme, restricted external validity, ad small sample size.

Further reading:

https://journals.lww.com/greenjournal/Fulltext/2023/06000/Cabergoline_for_Lactation_Inhibition_After.11.aspx