Satisfaction of Patients With the Chosen Method of Inhibition of Lactation
- Conditions
- Lactation Suppressed
- Interventions
- Registration Number
- NCT04038749
- Lead Sponsor
- Żelazna Medical Centre, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
- 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)
- Less than 18 years of age
- Lack of patient's consent
- To the pharmacotherapy group- contraindications for the use of the medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmaceutical method- Bromocriptine Natural methods - Pharmaceutical method- Bromocriptine Bromocriptine - Without medications that inhibit lactation Natural methods - Pharmaceutical method- Cabergoline Natural methods - Pharmaceutical method- Cabergoline Cabergoline -
- Primary Outcome Measures
Name Time Method 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 "+".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.
- Secondary Outcome Measures
Name Time Method 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 rightSurvey: 3rd-5th day of lactation suppression 3rd-5th day of lactation suppression Question about:
• ailments, problems and extra methods of relief of symptoms
Trial Locations
- Locations (1)
Żelazna Medical Centre
🇵🇱Warsaw, Poland