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.

Verified by University Hospital, Ghent, April 2009

First Received: June 13, 2008 Last Updated: April 17, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding Postpartum Care

U.S. FDA Resources

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 postpartum. ] [ 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 postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (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	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

Additional Information:

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

No publications provided

Responsible Party:	University Hospital Ghent ( Luc Van Bortel, MD, PhD )
Study ID Numbers:	2008/297
Study First Received:	June 13, 2008
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00699738 History of Changes
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 July 06, 2009