BreastfeedingBABSSNCT06844019
Birth & Breastfeeding Support Study
An observational study of Breastfeeding and Breastfeeding Initiation, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The goal of this observational study is to learn about the effects of birth practices such as cesarean section and vacuum assisted birth and diseases such as gestational diabetes and preeclampsia on exclusive breastfeeding. 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
- Breastfeeding, Breastfeeding Initiation, Breastfeeding Duration
- How many people
- 1,628 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Pregnant women and women who have given birth > 18 years old
Inclusion Criteria: 18 years, intention to breastfeed, single gestation, reads and understands Danish -
Exclusion Criteria: Twin gestation, less than 18 years, no intention to breastfeed, does not read and understand Danish
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dorrit Vizel-Schwartz, MSN, CNM, IBCLC, Ph.d.-student contact
Denmark1 site, 1 recruiting
- Recruiting
Herlev & Gentofte University Hospital
Herlev, 2730
Dorrit Vizel-Schwartz, MSN, CNM, IBCLC Ph.d.-student, +45 3188 2258, dorrit.vizel-schwartz@regionh.dk
Thomas Bergholt, Professor, PhD, MSc
About this study
The goal of this observational study is to learn about the effects of birth practices such as cesarean section and vacuum assisted birth and diseases such as gestational diabetes and preeclampsia on exclusive breastfeeding. The main question it aims to answer is:
- Does cesarean section, vacuum assisted birth, gestational diabetes and preeclampsia affect exclusive breastfeeding three months after birth? Participants answer eight online survey questions. One survey is distributed before birth and the remaining seven surveys are distributed after birth at three, seven and four-teen days, as well as one, three, six and twelve months after birth.
- Conditions
- Breastfeeding, Breastfeeding Initiation, Breastfeeding Duration, Birth, Birth Practices, Gestational Diabetes Mellitus (GDM)
- Keywords
- Birth, birth practices, gestational diabetes, preeclampsia, breastfeeding
- Medical subject headings
- Breast Feeding, Diabetes, Gestational, Pre-Eclampsia
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 |
|---|---|---|
| Cesarean Section | Birth by cesarean section and exclusive breastfeeding at 3 months of age | |
| Vacuum Assisted Birth | Birth by vacuum assist and exclusive breastfeeding at 3 months of age | |
| Gestational Diabetes | Birth afflicted by gestational diabetes and exclusive breastfeeding at 3 months of age | |
| Preeclampsia | Birth afflicted by preeclampsia and exclusive breastfeeding at 3 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Breastfeeding
Infant receives mothers milk exclusively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start6 Jan 2025
- Primary completion6 Jan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Jangö, University of Copenhagen
- Investigators
- Thomas Bergholt, Professor, PhD, MSc, Principal investigator, Herlev & Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844019
- Sponsor's protocol ID
- F-24074649
- Acronym
- BABSS
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not at this time.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth & Breastfeeding Support Study
- ClinicalTrials.gov ID
- NCT06844019
- Acronym / sponsor ID
- BABSS / F-24074649
- Conditions
- Breastfeeding, Breastfeeding Initiation, Breastfeeding Duration, Birth, Birth Practices, Gestational Diabetes Mellitus (GDM)
- Keywords
- Birth, birth practices, gestational diabetes, preeclampsia, breastfeeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,628 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Feb 2025 (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 goal of this observational study is to learn about the effects of birth practices such as cesarean section and vacuum assisted birth and diseases such as gestational diabetes and preeclampsia on exclusive breastfeeding. The main question it aims to answer is:
- Does cesarean section, vacuum assisted birth, gestational diabetes and preeclampsia affect exclusive breastfeeding three months after birth? Participants answer eight online survey questions. One survey is distributed before birth and the remaining seven surveys are distributed after birth at three, seven and four-teen days, as well as one, three, six and twelve months after birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cesarean Section | – | –Birth by cesarean section and exclusive breastfeeding at 3 months of age |
| Vacuum Assisted Birth | – | –Birth by vacuum assist and exclusive breastfeeding at 3 months of age |
| Gestational Diabetes | – | –Birth afflicted by gestational diabetes and exclusive breastfeeding at 3 months of age |
| Preeclampsia | – | –Birth afflicted by preeclampsia and exclusive breastfeeding at 3 months of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women and women who have given birth > 18 years old
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
Exclusive Breastfeeding
Time frame: 3 months
Infant receives mothers milk exclusively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Undecided. Not at this time.
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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.
Dorrit Vizel-Schwartz, MSN, CNM, IBCLC, Ph.d.-student contact
Thomas Bergholt, Professor, PhD, MSc principal investigator
Herlev & Gentofte 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 Breastfeeding and Breastfeeding Initiation, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorrit Vizel-Schwartz, MSN, CNM, IBCLC, Ph.d.-student (+45 3188 2258, dorrit.vizel-schwartz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive Breastfeeding (time frame: 3 months). 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 28 May 2025.