A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorStanford University

About this trial

Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. This study seeks to determine if investigators can more precisely manage these patients with a reduced dose appropriate for the physiology of the second trimester, thereby reducing the medication cost and reducing or eliminating the uncomfortable medication side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant people, ages 18 years or older

Intrauterine pregnancy between 16/0-25/6 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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cabergoline

    Drug

    Cabergoline

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Cabergoline 1 mg tabActive comparator 1 intervention
Group B: Cabergoline 0.5 mg tabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with serum prolactin level less than 23 ng/mL

Comparison of the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level (defined as less than 23ng/mL) to those receiving cabergoline 1 mg

Time frame
Day 4

Secondary outcomes

1

Number of participants with breast symptoms

Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.

Time frame
Day 4

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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