Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Lactation Suppressed

Intervention / Treatment
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* Drug: Bromocriptine
* Drug: Cabergoline
* Other: Natural methods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical method- Bromocriptine<br> | Drug: Bromocriptine<br>* 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)<br>* Other names: Bromergon;Other: Natural methods<br>* milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.<br>|
| Experimental: Pharmaceutical method- Cabergoline<br> | Drug: Cabergoline<br>* Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days<br>* Other names: Dostinex;Other: Natural methods<br>* milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.<br>|
| Other: Without medications that inhibit lactation<br> | Other: Natural methods<br>* milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.<br>|

What is the study measuring?
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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 |