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

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ClinicalTrials.gov Identifier: NCT00699738
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Behavioral: Breastfeeding Behavioral: Bottlefeeding Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hemodynamical effects of pregnancy and post-partum feeding method [ Time Frame: At approx 8 weeks postpartum. ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00699738     History of Changes
Other Study ID Numbers: 2008/297
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

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