Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

Satisfaction of Patients With the Chosen Method of Inhibition of Lactation: With the Use of Drugs Lowering the Level of Prolactin or Without the Use of Pharmacological Agents in Postnatal Period, Taking Into Account Individual Conditions

The aim of the study is to improve the standard of care in case of the inhibition of lactation.

The participant qualified for the study will answer the questions contained in the survey. The patient will have her breast palpated and then will be instructed on the possible options for the inhibition of lactation. The participant, who decides to inhibit lactation with medications, will be consulted by a doctor.

Each patient will receive information of the possible ways to relieve the symptoms of overfilled breast and be able to contact with lactation consultant. The participant will also receive a card to assess the severity of symptoms in the following days. The investigators will call the patient between the third and fifth day by phone.

Once again, after 2 weeks from the beginning of the inhibition of lactation in order to ask questions contained in the survey (the course of the process, problems that occurred and the level of satisfaction with the chosen method).

Study Overview

• Status: Recruiting
• Conditions: Lactation Suppressed
• Intervention / Treatment: Drug: Bromocriptine; Other: Natural methods; Drug: Cabergoline

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicja Misztal, MSc; Phone Number: +48 513 007 355; Email: alicja.misztal@gmail.com
• Study Contact Backup: Name: Kinga Osuch, MSc; Phone Number: + 48 500 003 697; Email: ki.osuch@gmail.com

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Żelazna Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Mother during the period of six weeks after childbirth
• Decision to inhibit lactation
• Patient's age at the time of enrollment (at least 18 years old)

Exclusion Criteria:

• Less than 18 years of age
• Lack of patient's consent
• To the pharmacotherapy group- contraindications for the use of the medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmaceutical method- Bromocriptine	Drug: Bromocriptine; Bromocriptine - on the first day of treatment (1,25 mg) with morning and evening meal and then 2,5 mg dose twice a day for two weeks (14 days); Other Names: Bromergon; Other: Natural methods; milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.
Experimental: Pharmaceutical method- Cabergoline	Other: Natural methods; milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.; Drug: Cabergoline; Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days; Other Names: Dostinex
Other: Without medications that inhibit lactation	Other: Natural methods; milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Pain assesment by Visual Analogue Scale (VAS scale), range 0-10, higher numbers represents worse outcome.	from the 1st day of the inhibition of lactation to 14th day of process
Evaluation of breast status	Daily evaluation of breast status. Are they: heavy, full, swollen (engorged), warmed up, hard, irregular, leaking. Gradations of symptoms intensity by using (+) and (-) where: "-" - means not at all; "+" - means a little; "++" - means a lot; "+++" - means very (highest level)	from the 1st day of the inhibition of lactation to 14th day of process
Symptoms in association with the ingestion of medicines that inhibit lactation.	headache; constipation; stomach pain; general weakness; somnolence; vomiting; dizziness; nausea; other Symptoms that occurred are marked with a "+".	from the 1st day of the inhibition of lactation to 14th day of process
Breast palpation	• Size (each one separately; left and right breast); hypoplastic; small; average; big The correct answer is marked with a "+". • Anomalies (each one separately; left and right breast); no change; swollen; redness; warming; achiness; scars The correct answer is marked with a "+".	1st day of including in the study
Survey: 1st day of including in the study	Questions about: parturition,; previous lactations,; cause of lactation suppression,; factors which may impair lactation,; contraindications to medications that suppress lactation,; current lactation,; the way to suppress lactation.	1st day of including in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey: 3rd-5th day of lactation suppression	Question about: • ailments, problems and extra methods of relief of symptoms	3rd-5th day of lactation suppression
Survey: 14th-16th day of lactation suppression	Questions about: specific ailments and problems during the inhibition of lactation process (such as. pain, feeling of heaviness, temperature, low-grade fever/higher fever, stasis, mastitis, breast abscess, side effects caused by medications); applied methods to ease ailments: (milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea).; assessment whether the decision on how to inhibit lactation was right	14th-16th day of lactation suppression

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline; Bromocriptine
• Other Study ID Numbers: 23/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No