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Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

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ClinicalTrials.gov Identifier: NCT04038749
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Alicja Misztal, 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).


Condition or disease Intervention/treatment Phase
Lactation Suppressed Drug: Bromocriptine Drug: Cabergoline Other: Natural methods Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Pharmaceutical method- Bromocriptine 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)
Other Name: Bromergon

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

Experimental: Pharmaceutical method- Cabergoline Drug: Cabergoline
Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days
Other Name: Dostinex

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

Without medications that inhibit lactation Other: Natural methods
milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 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.

  2. Evaluation of breast status [ Time Frame: 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)

  3. Symptoms in association with the ingestion of medicines that inhibit lactation. [ Time Frame: 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 "+".


  4. Breast palpation [ Time Frame: 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 "+".


  5. Survey: 1st day of including in the study [ Time Frame: 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 :
  1. Survey: 3rd-5th day of lactation suppression [ Time Frame: 3rd-5th day of lactation suppression ]

    Question about:

    • ailments, problems and extra methods of relief of symptoms


  2. Survey: 14th-16th day of lactation suppression [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038749


Contacts
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Contact: Alicja Misztal, MSc +48 513 007 355 alicja.misztal@gmail.com
Contact: Kinga Osuch, MSc + 48 500 003 697 ki.osuch@gmail.com

Locations
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Poland
Żelazna Medical Centre Recruiting
Warsaw, Poland
Sponsors and Collaborators
Żelazna Medical Centre, LLC
Investigators
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Study Chair: Dorota Sys, PhD Centre of Postgraduate Medical Education

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Responsible Party: Alicja Misztal, Investigator, Żelazna Medical Centre, LLC
ClinicalTrials.gov Identifier: NCT04038749     History of Changes
Other Study ID Numbers: 23/2019
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cabergoline
Bromocriptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists