NCT00699738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 24, 2012

Status Verified

May 1, 2012

Enrollment Period

1.5 years

First QC Date

June 13, 2008

Last Update Submit

May 23, 2012

Conditions

Healthy

Keywords

Healthy women during pregnancy and in the postpartum period

Outcome Measures

Primary Outcomes (1)

  • Hemodynamical effects of pregnancy and post-partum feeding method

    At approx 8 weeks postpartum.

Secondary Outcomes (1)

  • Effect of the pregnant state and the choice of post-partum feeding method on the parameters of the central and peripheral hemodynamics

    At approx 8 weeks postpartum

Study Arms (3)

1

EXPERIMENTAL

Healthy women during pregnancy and in the postpartum period, breastfeeding

Behavioral: Breastfeeding

2

ACTIVE COMPARATOR

Healthy women during pregnancy and in the postpartum period,bottlefeeding

Behavioral: Bottlefeeding

3

NO INTERVENTION

Healthy non-pregnant women

Interventions

BreastfeedingBEHAVIORAL

Breastfeeding

1
BottlefeedingBEHAVIORAL

Bottlefeeding

2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Luc Van Bortel, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 24, 2012

Record last verified: 2012-05

Locations

BE(1)