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

May 23, 2012 updated by: University Hospital, Ghent
This study will evaluate the physiological and pathophysiological determinants of pregnancy and feeding method on the maternal cardiovascular system. This includes non-invasive measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Healthy women during pregnancy and in the postpartum period, breastfeeding
Behavioral: Breastfeeding
Breastfeeding
Active Comparator: 2
Healthy women during pregnancy and in the postpartum period,bottlefeeding
Behavioral: Bottlefeeding
Bottlefeeding
No Intervention: 3
Healthy non-pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemodynamical effects of pregnancy and post-partum feeding method
Time Frame: At approx 8 weeks postpartum.
At approx 8 weeks postpartum.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At approx 8 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 23, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008/297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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