Birth & Breastfeeding Support Study

NCT06844019 | Recruiting

• 1 other identifier: F-24074649
• Study Type: observational
• Target: 1,628
• Locations: 1 country
• Sites: 1

Brief 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. 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); Preeclampsia

Keywords

Birth, birth practices, gestational diabetes, preeclampsia; breastfeeding

Outcome Measures

Primary Outcomes (1)

• Exclusive Breastfeeding

  Infant receives mothers milk exclusively

  3 months

Study Arms (4)

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

Eligibility Criteria

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

Study Population

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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev & Gentofte University Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Diabetes, Gestational; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Thomas Bergholt, Professor, PhD, MSc

  Herlev & Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorrit Vizel-Schwartz, MSN, CNM, IBCLC, Ph.d.-student

CONTACT

+45 3188 2258; dorrit.vizel-schwartz@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant Obstetrician, PhD

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

DK (1)