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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

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 June 17, 2013