Lactation SuppressedNCT04038749
Satisfaction of Patients With the Chosen Method of Inhibition of Lactation
A study testing Bromocriptine, Cabergoline and Natural methods in people with Lactation Suppressed, run by Żelazna Medical Centre, LLC at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Suppressed
- What is being tested?
- Bromocriptine, Cabergoline and Natural methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jun 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Less than 18 years of age
- Lack of patient's consent
- To the pharmacotherapy group- contraindications for the use of the medication
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Bromocriptine, Cabergoline, Natural methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromocriptineDrug
Also called Bromergon
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)
CabergolineDrug
Also called Dostinex
Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days
Natural methodsOther
milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical method- Bromocriptine | Experimental | Not described Receives: Drug: Bromocriptine; Other: Natural methods |
| Pharmaceutical method- Cabergoline | Experimental | Not described Receives: Drug: Cabergoline; Other: Natural methods |
| Without medications that inhibit lactation | Other | Not described Receives: Other: Natural methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Pain assesment by Visual Analogue Scale (VAS scale), range 0-10, higher numbers represents worse outcome.
Measured: 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)
Measured: 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 "+".
Measured: 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 "+".
Measured: 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.
Measured: 1st day of including in the study
Secondary outcomes (2)
Survey: 3rd-5th day of lactation suppression
Question about:
- ailments, problems and extra methods of relief of symptoms
Measured: 3rd-5th day of lactation suppression
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
Measured: 14th-16th day of lactation suppression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start16 Jun 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation SuppressedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicja Misztal, Żelazna Medical Centre, LLC
- Investigators
- Dorota Sys, PhD, Study chair, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038749
- Sponsor's protocol ID
- 23/2019
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04038749
- Acronym / sponsor ID
- 23/2019
- Conditions
- Lactation Suppressed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Lack of patient's consent
- To the pharmacotherapy group- contraindications for the use of the medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromocriptineAlso: BromergonBromocriptine - 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) | Drug | Pharmaceutical method- Bromocriptine |
| CabergolineAlso: DostinexCabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days | Drug | Pharmaceutical method- Cabergoline |
| Natural methodsmilk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea. | Other | Pharmaceutical method- Bromocriptine, Pharmaceutical method- Cabergoline, Without medications that inhibit lactation |
Primary outcome
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.
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)
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 "+".
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 "+".
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.
2 secondary outcomes
Survey: 3rd-5th day of lactation suppression
Time frame: 3rd-5th day of lactation suppression
Survey: 14th-16th day of lactation suppression
Time frame: 14th-16th day of lactation suppression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Sys, PhD study chair
Centre of Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromocriptine, Cabergoline and Natural methods in people with Lactation Suppressed, run by Żelazna Medical Centre, LLC at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicja Misztal, MSc (+48 513 007 355, alicja.misztal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: from the 1st day of the inhibition of lactation to 14th day of process). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.