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NCT00699738 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00699738
Other study ID # 2008/297
Secondary ID
Status Completed
Phase N/A
First received June 13, 2008
Last updated May 23, 2012
Start date July 2008
Est. completion date January 2010

Study information
Verified date May 2012
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Breastfeeding
Breastfeeding
• Bottlefeeding
Bottlefeeding

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamical effects of pregnancy and post-partum feeding method At approx 8 weeks postpartum. No
Secondary Effect of the pregnant state and the choice of post-partum feeding method on the parameters of the central and peripheral hemodynamics At approx 8 weeks postpartum No
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