HealthyNCT00699738
Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
A study testing Breastfeeding and Bottlefeeding in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breastfeeding and Bottlefeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the physiological and pathophysiological determinants of pregnancy and feeding method on the maternal cardiovascular system. This includes non-invasive measurements.
- Conditions
- Healthy
- Being tested
- Breastfeeding, Bottlefeeding
- Keywords
- Healthy women during pregnancy and in the postpartum period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingBehavioural
Breastfeeding
BottlefeedingBehavioural
Bottlefeeding
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy women during pregnancy and in the postpartum period, breastfeeding Receives: Behavioral: Breastfeeding |
| 2 | Active comparator | Healthy women during pregnancy and in the postpartum period,bottlefeeding Receives: Behavioral: Bottlefeeding |
| 3 | No intervention | Healthy non-pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamical effects of pregnancy and post-partum feeding method
Measured: 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
Measured: At approx 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Van Bortel, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699738
- Sponsor's protocol ID
- 2008/297
- Status last verified
- May 2012
- First submitted
- 13 Jun 2008
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
- ClinicalTrials.gov ID
- NCT00699738
- Acronym / sponsor ID
- 2008/297
- Conditions
- Healthy
- Keywords
- Healthy women during pregnancy and in the postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: BreastfeedingHealthy women during pregnancy and in the postpartum period, breastfeeding |
| 2 | Active comparator | Behavioral: BottlefeedingHealthy women during pregnancy and in the postpartum period,bottlefeeding |
| 3 | No intervention | –Healthy non-pregnant women |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastfeedingBreastfeeding | Behavioural | 1 |
| BottlefeedingBottlefeeding | Behavioural | 2 |
Primary outcome
Hemodynamical effects of pregnancy and post-partum feeding method
Time frame: At approx 8 weeks postpartum.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Van Bortel, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding and Bottlefeeding in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamical effects of pregnancy and post-partum feeding method (time frame: At approx 8 weeks postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2012.