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

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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 not yet open for participant recruitment.

Study NCT00699738. Last updated on June 17, 2008. Information provided by University Hospital, Ghent

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Health Services Research, Open Label, Active Control, Parallel Assignment

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Healthy

Intervention ^†

Behavioral: Breastfeeding
Behavioral: Bottlefeeding

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

280

Start Date ^†

July 2008

Completion Date

December 2009

Eligibility 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

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Isabelle Fabry, MD

Isabelle.fabry@ugent.be

Location Countries ^†

Belgium

Administrative Information Fields

NCT ID ^†

NCT00699738

Organization ID

2008/297

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Ghent

Collaborators ^††

Investigators ^†

Principal Investigator:

Luc Van Bortel, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

June 2008

First Received Date ^†

June 13, 2008

Last Updated Date

June 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.