Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

NCT04038749 | Unknown

• 1 other identifier: 23/2019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Lactation Suppressed

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Survey: 3rd-5th day of lactation suppression

  3rd-5th day of lactation suppression

• Survey: 14th-16th day of lactation suppression

  14th-16th day of lactation suppression

Study Arms (3)

Pharmaceutical method- Bromocriptine

EXPERIMENTAL

Drug: Bromocriptine; Other: Natural methods

Pharmaceutical method- Cabergoline

EXPERIMENTAL

Drug: Cabergoline; Other: Natural methods

Without medications that inhibit lactation

OTHER

Other: Natural methods

Interventions

Bromocriptine 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)

Also known as: Bromergon

Pharmaceutical method- Bromocriptine

Cabergoline DRUG

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

Also known as: Dostinex

Pharmaceutical method- Cabergoline

Natural methods OTHER

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

Pharmaceutical method- Bromocriptine; Pharmaceutical method- Cabergoline; Without medications that inhibit lactation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Less than 18 years of age
• Lack of patient's consent
• To the pharmacotherapy group- contraindications for the use of the medication

Sponsors & Collaborators

• Żelazna Medical Centre, LLC: lead

Study Sites (1)

Żelazna Medical Centre

Warsaw, Poland

RECRUITING

MeSH Terms

Interventions

Bromocriptine; Cabergoline; Natural Family Planning Methods

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Contraception; Reproductive Techniques; Therapeutics

Study Officials

• Dorota Sys, PhD

  Centre of Postgraduate Medical Education

  STUDY CHAIR

Central Study Contacts

Alicja Misztal, MSc

CONTACT

+48 513 007 355; alicja.misztal@gmail.com

Kinga Osuch, MSc

CONTACT

+ 48 500 003 697; ki.osuch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 31, 2019
• Study Start: June 16, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)