Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

Lactation Suppressed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038749
• Other study ID #: 23/2019
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2019
• Source: Zelazna Medical Centre, LLC
• Contact: Alicja Misztal, MSc
• Phone: +48 513 007 355
• Email: alicja.misztal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation Suppressed

Intervention

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)
• Cabergoline
Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days

Other:
• Natural methods
milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

Locations

Country	Name	City	State
Poland	Zelazna Medical Centre	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Survey: 3rd-5th day of lactation suppression	Question about: • ailments, problems and extra methods of relief of symptoms	3rd-5th day of lactation suppression
Secondary	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