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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 is currently recruiting participants.
Study NCT00699738   Information provided by University Hospital, Ghent
First Received: June 13, 2008   Last Updated: April 17, 2009   History of Changes

June 13, 2008
April 17, 2009
July 2008
February 2010   (final data collection date for primary outcome measure)
Hemodynamical effects of pregnancy and post-partum feeding method [ Time Frame: At approx 8 weeks postpartum. ] [ Designated as safety issue: No ]
Hemodynamical effects of pregnancy and post-partum feeding method [ Time Frame: At approx 8 weeks after stopping breast-feeding or a matched time point estimated between 16-24 weeks postpartum for bottle-feeding mothers ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00699738 on ClinicalTrials.gov Archive Site
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 ]
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 after stopping breast-feeding or a matched time point estimated between 16-24 weeks postpartum for bottle-feeding mothers ] [ Designated as safety issue: No ]
 
Influence of Pregnancy and Post-Partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
Influence of Pregnancy and Post-Partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function

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

 
 
Interventional
Health Services Research, Open Label, Active Control, Parallel Assignment
Healthy
  • Behavioral: Breastfeeding
  • Behavioral: Bottlefeeding
  • Experimental: Healthy women during pregnancy and in the postpartum period, breastfeeding
  • Active Comparator: Healthy women during pregnancy and in the postpartum period,bottlefeeding
  • No Intervention: Healthy non-pregnant women
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
280
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
Yes
Contact: Isabelle Fabry, MD Isabelle.fabry@ugent.be
Belgium
 
NCT00699738
Luc Van Bortel, MD, PhD, University Hospital Ghent
2008/297
University Hospital, Ghent
 
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
University Hospital, Ghent
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP