Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00699738
First received: June 13, 2008
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

This study will evaluate the physiological and pathophysiological determinants of pregnancy and feeding method on the maternal cardiovascular system. This includes non-invasive measurements.


Condition Intervention
Healthy
Behavioral: Breastfeeding
Behavioral: Bottlefeeding

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Hemodynamical effects of pregnancy and post-partum feeding method [ Time Frame: At approx 8 weeks postpartum. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of the pregnant state and the choice of post-partum feeding method on the parameters of the central and peripheral hemodynamics [ Time Frame: At approx 8 weeks postpartum ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Healthy women during pregnancy and in the postpartum period, breastfeeding
Behavioral: Breastfeeding
Breastfeeding
Active Comparator: 2
Healthy women during pregnancy and in the postpartum period,bottlefeeding
Behavioral: Bottlefeeding
Bottlefeeding
No Intervention: 3
Healthy non-pregnant women

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 and 40 years old
  • Singleton pregnancy
  • First pregnancy at the minimum age of 18 years
  • In good health, especially no cardiovascular diseases, diabetes or a BMI > 30 kg/m2
  • Capable in understanding properly the ICF and the investigators

Exclusion Criteria:

  • On chronic medication, especially antihypertensive or antidiabetical drugs
  • Multiple pregnancy
  • First pregnancy before the age of 18 years old
  • Smoking more than 10 cigarettes/day, drinking more than 3 units of alcohol/day or more than 5-6 units of caffeine-containing drinks
  • The use of any extralegally drugs
  • Not able to have reliable blood pressure or hemodynamic data at screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699738

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00699738     History of Changes
Other Study ID Numbers: 2008/297
Study First Received: June 13, 2008
Last Updated: May 23, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Healthy women during pregnancy and in the postpartum period

ClinicalTrials.gov processed this record on July 24, 2014