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

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

April 17, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hemodynamical effects of pregnancy and post-partum feeding method [ Time Frame: At approx 8 weeks postpartum. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00699738 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Behavioral: Breastfeeding
Behavioral: Bottlefeeding

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

280

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Isabelle Fabry, MD

Isabelle.fabry@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00699738

Responsible Party

Luc Van Bortel, MD, PhD, University Hospital Ghent

Study ID Numbers ^ICMJE

2008/297

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Luc Van Bortel, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

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