Lactation Suppressed
Conditions
Brief summary
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).
Interventions
DRUGBromocriptine
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)
DRUGCabergoline
Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days
OTHERNatural methods
milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.
Sponsors
Żelazna Medical Centre, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of breast status | from the 1st day of the inhibition of lactation to 14th day of process | 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) |
| Breast palpation | 1st day of including in the study | • 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 +. |
| Survey: 1st day of including in the study | 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. |
| Visual Analogue Scale (VAS) | from the 1st day of the inhibition of lactation to 14th day of process | Pain assesment by Visual Analogue Scale (VAS scale), range 0-10, higher numbers represents worse outcome. |
| Symptoms in association with the ingestion of medicines that inhibit lactation. | from the 1st day of the inhibition of lactation to 14th day of process | * headache * constipation * stomach pain * general weakness * somnolence * vomiting * dizziness * nausea * other Symptoms that occurred are marked with a +. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey: 14th-16th day of lactation suppression | 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 |
| Survey: 3rd-5th day of lactation suppression | 3rd-5th day of lactation suppression | Question about: • ailments, problems and extra methods of relief of symptoms |
Countries
Poland
Contacts
Primary ContactAlicja Misztal, MSc
Backup ContactKinga Osuch, MSc
Outcome results
None listed