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

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.
Verified by University Hospital, Ghent, June 2008

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00699738

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

MedlinePlus related topics:

Breast Feeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Active Control, Parallel Assignment

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

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 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 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 after stopping breast-feeding or a matched time point estimated between 16-24 weeks postpartum for bottle-feeding mothers ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Healthy women during pregnancy and in the postpartum period, breastfeeding	Behavioral: Breastfeeding Breastfeeding
2: Active Comparator Healthy women during pregnancy and in the postpartum period,bottlefeeding	Behavioral: Bottlefeeding Bottlefeeding
3: No Intervention 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

Contacts


Contact: Isabelle Fabry, MD		Isabelle.fabry@ugent.be

Locations


Belgium
	University Hospital Ghent	Not yet recruiting
	Ghent, Belgium, 9000
	Sub-Investigator: Isabelle Fabry, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators


Principal Investigator:	Luc Van Bortel, MD, PhD	University Hospital, Ghent

More Information

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

Responsible Party:	University Hospital Ghent ( Luc Van Bortel, MD, PhD )
Study ID Numbers:	2008/297
First Received:	June 13, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00699738
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Healthy women during pregnancy and in the postpartum period

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 10, 2008