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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Less than 18 years of age
- •Lack of patient's consent
- •To the pharmacotherapy group- contraindications for the use of the medication
研究组 & 干预措施
Pharmaceutical method- Bromocriptine
干预措施: Bromocriptine (Drug)
Pharmaceutical method- Bromocriptine
干预措施: Natural methods (Other)
Pharmaceutical method- Cabergoline
干预措施: Cabergoline (Drug)
Pharmaceutical method- Cabergoline
干预措施: Natural methods (Other)
Without medications that inhibit lactation
干预措施: Natural methods (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 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.
时间窗: 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 "+".
Breast palpation
时间窗: 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 "+".
Evaluation of breast status
时间窗: 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)
Survey: 1st day of including in the study
时间窗: 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.
次要结局
- Survey: 14th-16th day of lactation suppression(14th-16th day of lactation suppression)
- Survey: 3rd-5th day of lactation suppression(3rd-5th day of lactation suppression)
研究者
Alicja Misztal
Investigator
Żelazna Medical Centre, LLC