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

NCT ID: NCT00699738

Last Updated: 2012-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Healthy women during pregnancy and in the postpartum period, breastfeeding

Group Type EXPERIMENTAL

Breastfeeding

Intervention Type BEHAVIORAL

Breastfeeding

2

Healthy women during pregnancy and in the postpartum period,bottlefeeding

Group Type ACTIVE_COMPARATOR

Bottlefeeding

Intervention Type BEHAVIORAL

Bottlefeeding

3

Healthy non-pregnant women

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastfeeding

Breastfeeding

Intervention Type BEHAVIORAL

Bottlefeeding

Bottlefeeding

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Van Bortel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2008/297

Identifier Type: -

Identifier Source: org_study_id

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