Lactation SuppressedNCT03965572
Factors and Outcomes Associated With Postpartum Cabergoline Use
An observational study of Lactation Suppressed and Cabergoline Adverse Reaction, run by Laniado Hospital at 1 site in Israel.
Trial summary
Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing. Read more about this study
- Who is it for?
- Ages 16 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Suppressed, Cabergoline Adverse Reaction, Postpartum DVT
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Jun 2019to 12 May 2023
- Phase
- Observational
- 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 16 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We are studying the demographics, motivations, and outcomes of women who request cabergoline for lactation suppression following a live birth.
Who may be able to join
- Postpartum women
- After a live birth
- Requesting cabergoline for lactation suppression
Who cannot join
- those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Laniado Hospital, The Betty Retter Mother & Baby Medical Center
Netanya
Weisbrod, Dr., 972-9-8604601
About this study
Official title: Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.
Read the detailed description
Cabergoline is a dopamine receptor agonist. Outside of the United States, it is occasionally used to suppress lactation, most commonly after a pregnancy loss or stillbirth. However, the investigators noted that the patient population in Israel has been requesting cabergoline for administration after healthy births, for immediate lactation suppression.
Use of cabergoline after delivery comes with many concerns. One primary concern is that this medication can increase the risk of venous thrombotic events, particularly during postpartum when thrombosis risk is already elevated. Secondly, it may have effects that alter mood, which are similarly concerning during a vulnerable period when postpartum depression and other mental health disorders are common.
Finally, of course, is the issue that so many women are requesting lactation suppression immediately after birth, and therefore will not accrue the neonatal and maternal benefits of lactation.
The investigators want to understand the characteristics, demographics and other factors that lead these women to make this choice, as well as assess their risk of medical and psychological adverse effects from cabergoline used in the postpartum period.
During this study, the investigators will not be prescribing cabergoline or in any way affecting its use. The study will be recruiting as subjects women who requested and received cabergoline prescriptions independently, as is common practice throughout the country.
The study will involve three questionnaires with these subjects: one in the hospital, after birth; one a week after birth; and one 6 weeks after birth. The questionnaires will involve medical history, a validated lactation questionnaire, as well as demographic data. All data will be held in a private, password-locked database.
- Keywords
- cabergoline, lactation, suppression, postpartum care
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum women who requested cabergoline | A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression. | |
| Control group | An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics of women requesting cabergoline
Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
Measured: immediate postpartum
Number of participants experiencing immediate treatment-related adverse events
Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
Measured: immediate postpartum
Number of participants experiencing early treatment-related adverse events
Adverse effects experienced by women taking cabergoline within 1 week after treatment will be recorded using questionnaire with focus on thromboembolic events, and depression or mood changes.
Measured: 1 week postpartum
Number of participants experiencing late treatment-related adverse events
Adverse effects experienced by women taking cabergoline within 6 weeks after treatment, will be recorded using questionnaire, with focus on thromboembolic events, and depression or mood changes.
Measured: six weeks postpartum
Secondary outcomes (1)
Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth
Questionnaire assessing motivations expressed by women requesting cabergoline for lactation suppression postpartum, using questionnaire
Measured: immediate postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start7 Jun 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion12 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laniado Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarit Kalfon, Laniado Hospital
- Investigators
- Sarit Kalfon, MD, Principal investigator, Laniado Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965572
- Sponsor's protocol ID
- 0017-19-LND
- Status last verified
- Sep 2021
- First submitted
- 15 May 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlSaad D, ElSalem S, Abdulrouf PV, Thomas B, Alsaad T, Ahmed A, AlHail M. A retrospective drug use evaluation of cabergoline for lactation inhibition at a tertiary care teaching hospital in Qatar. Ther Clin Risk Manag. 2016 Feb 9;12:155-60. doi: 10.2147/TCRM.S96298. eCollection 2016.
PubMed 26929627Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
PubMed 22946888Ben Natan M, Wiener A, Ben Haim Y. Women׳s intention to exclusively breast feed: The Israeli perspective. Midwifery. 2016 Mar;34:173-177. doi: 10.1016/j.midw.2015.11.013. Epub 2015 Nov 22.
PubMed 26652854McGuire TM. Drugs affecting milk supply during lactation. Aust Prescr. 2018 Feb;41(1):7-9. doi: 10.18773/austprescr.2018.002. Epub 2018 Feb 1. No abstract available.
PubMed 29507453Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005937. doi: 10.1002/14651858.CD005937.pub3.
PubMed 22972088Senat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, Deffieux X, Diers F, Doret M, Ducroux-Schouwey C, Fuchs F, Gascoin G, Lebot C, Marcellin L, Plu-Bureau G, Raccah-Tebeka B, Simon E, Breart G, Marpeau L. Postpartum practice: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:1-8. doi: 10.1016/j.ejogrb.2016.04.032. Epub 2016 Apr 29.
PubMed 27155443
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
- ClinicalTrials.gov ID
- NCT03965572
- Acronym / sponsor ID
- 0017-19-LND
- Keywords
- cabergoline, lactation, suppression, postpartum care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laniado HospitalUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 12 May 2023 (estimated)
- First posted
- 29 May 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.
Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.
Detailed description
Cabergoline is a dopamine receptor agonist. Outside of the United States, it is occasionally used to suppress lactation, most commonly after a pregnancy loss or stillbirth. However, the investigators noted that the patient population in Israel has been requesting cabergoline for administration after healthy births, for immediate lactation suppression.
Use of cabergoline after delivery comes with many concerns. One primary concern is that this medication can increase the risk of venous thrombotic events, particularly during postpartum when thrombosis risk is already elevated. Secondly, it may have effects that alter mood, which are similarly concerning during a vulnerable period when postpartum depression and other mental health disorders are common.
Finally, of course, is the issue that so many women are requesting lactation suppression immediately after birth, and therefore will not accrue the neonatal and maternal benefits of lactation.
The investigators want to understand the characteristics, demographics and other factors that lead these women to make this choice, as well as assess their risk of medical and psychological adverse effects from cabergoline used in the postpartum period.
During this study, the investigators will not be prescribing cabergoline or in any way affecting its use. The study will be recruiting as subjects women who requested and received cabergoline prescriptions independently, as is common practice throughout the country.
The study will involve three questionnaires with these subjects: one in the hospital, after birth; one a week after birth; and one 6 weeks after birth. The questionnaires will involve medical history, a validated lactation questionnaire, as well as demographic data. All data will be held in a private, password-locked database.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum women who requested cabergoline | – | –A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression. |
| Control group | – | –An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are studying the demographics, motivations, and outcomes of women who request cabergoline for lactation suppression following a live birth.
Key inclusion criteria (3 listed)
- Postpartum women
- After a live birth
- Requesting cabergoline for lactation suppression
Key exclusion criteria (1 listed)
- those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics of women requesting cabergoline
Time frame: immediate postpartum
Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
Number of participants experiencing immediate treatment-related adverse events
Time frame: immediate postpartum
Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
Number of participants experiencing early treatment-related adverse events
Time frame: 1 week postpartum
Adverse effects experienced by women taking cabergoline within 1 week after treatment will be recorded using questionnaire with focus on thromboembolic events, and depression or mood changes.
Number of participants experiencing late treatment-related adverse events
Time frame: six weeks postpartum
Adverse effects experienced by women taking cabergoline within 6 weeks after treatment, will be recorded using questionnaire, with focus on thromboembolic events, and depression or mood changes.
1 secondary outcome
Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth
Time frame: immediate postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 26929627AlSaad D, ElSalem S, Abdulrouf PV, Thomas B, Alsaad T, Ahmed A, AlHail M. A retrospective drug use evaluation of cabergoline for lactation inhibition at a tertiary care teaching hospital in Qatar. Ther Clin Risk Manag. 2016 Feb 9;12:155-60. doi: 10.2147/TCRM.S96298. eCollection 2016.
- Background: PubMed 22946888Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
- Background: PubMed 26652854Ben Natan M, Wiener A, Ben Haim Y. Women׳s intention to exclusively breast feed: The Israeli perspective. Midwifery. 2016 Mar;34:173-177. doi: 10.1016/j.midw.2015.11.013. Epub 2015 Nov 22.
- Background: PubMed 29507453McGuire TM. Drugs affecting milk supply during lactation. Aust Prescr. 2018 Feb;41(1):7-9. doi: 10.18773/austprescr.2018.002. Epub 2018 Feb 1. No abstract available.
- Background: PubMed 22972088Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005937. doi: 10.1002/14651858.CD005937.pub3.
- Background: PubMed 27155443Senat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, Deffieux X, Diers F, Doret M, Ducroux-Schouwey C, Fuchs F, Gascoin G, Lebot C, Marcellin L, Plu-Bureau G, Raccah-Tebeka B, Simon E, Breart G, Marpeau L. Postpartum practice: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:1-8. doi: 10.1016/j.ejogrb.2016.04.032. Epub 2016 Apr 29.
- Interim Report from Ministry of HealthLink provided by the sponsor.
- Breastfeeding basics: lactation suppressionLink provided by the sponsor.
- 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.
Sarit Kalfon, MD principal investigator
Laniado Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactation Suppressed and Cabergoline Adverse Reaction, run by Laniado Hospital at 1 site in Israel.
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 1 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 28 Sep 2021. 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 Israel. 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 Sarit Kalfon, MD (+972547922182, saritkalfon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics of women requesting cabergoline (time frame: immediate postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965572, which also lists 6 linked publications.
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 28 Sep 2021.