Birth & Breastfeeding Support Study (BABSS)

May 22, 2025 updated by: Hanna Jangö, Herlev Hospital

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev & Gentofte University Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Bergholt, Professor, PhD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women and women who have given birth > 18 years old

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding
Time Frame: 3 months
Infant receives mothers milk exclusively
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Thomas Bergholt, Professor, PhD, MSc, Herlev & Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-24074649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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