Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

NCT ID: NCT04038749

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-16

Study Completion Date

2022-12-31

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).

Detailed Description

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Conditions

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Lactation Suppressed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pharmaceutical method- Bromocriptine

Group Type EXPERIMENTAL

Bromocriptine

Intervention Type DRUG

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)

Natural methods

Intervention Type OTHER

milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

Pharmaceutical method- Cabergoline

Group Type EXPERIMENTAL

Cabergoline

Intervention Type DRUG

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

Natural methods

Intervention Type OTHER

milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

Without medications that inhibit lactation

Group Type OTHER

Natural methods

Intervention Type OTHER

milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

Interventions

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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)

Intervention Type DRUG

Cabergoline

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

Intervention Type DRUG

Natural methods

milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.

Intervention Type OTHER

Other Intervention Names

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Bromergon Dostinex

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Żelazna Medical Centre, LLC

OTHER

Sponsor Role lead

Responsible Party

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Alicja Misztal

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorota Sys, PhD

Role: STUDY_CHAIR

Centre of Postgraduate Medical Education

Locations

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Żelazna Medical Centre

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Alicja Misztal, MSc

Role: CONTACT

Phone: +48 513 007 355

Email: [email protected]

Kinga Osuch, MSc

Role: CONTACT

Phone: + 48 500 003 697

Email: [email protected]

Other Identifiers

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23/2019

Identifier Type: -

Identifier Source: org_study_id