1. To develop a postpartum strategy of appraisel of cardiovascular and metabolic health after pregnancies, complicated by PE, IUGR or GD.2. To develop and evaluate the feasibility of a lifestyle intervention strategy.3. To design a study proposal…
ID
Source
Brief title
Condition
- Lifestyle issues
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Development and feasibility of a lifestyle intervention strategy to prevent
type 2 diabetes mellitus and cardiovascular disease.
Secondary outcome
Adherence to the lifestyle intervention strategy and reason of lack of
adherence.
Weightloss.
Background summary
Secondary and primary prevention of cardiovascular disease (CVD) and type 2
diabetes mellitus (DM2) are difficult to achieve, mainly because of the lack of
an effective strategy to identify high-risk individuals at a young age. This
study uses the theory of pregnancy being a cardiovascular and metabolic
stress-test. Complications of pregnancy, such as preeclampsia (PE),
intrauterine growth restriction (IUGR) and gestational diabetes (GD), are
symptoms of increased cardiovascular or metabolic risk at later life. Lifestyle
interventions, and if necessary pharmakotherapeutic treatment, are possibly the
best way to reduce this risk. The complicated pregnancy creates a window of
opportunity for lifestyle interventions.
Study objective
1. To develop a postpartum strategy of appraisel of cardiovascular and
metabolic health after pregnancies, complicated by PE, IUGR or GD.
2. To develop and evaluate the feasibility of a lifestyle intervention strategy.
3. To design a study proposal for an effect evaluation of the developed
lifestyle intervention strategy.
Study design
During the first part of the study the lifestyle intervention strategy will be
developed for women with a complicated pregnancy (PE, IUGR, GD). New techniques
like 'computer based tailored intervention' will be used.
Information will be gathered by performing a search of the literature and by
focusgroup interviews.
Intervention
All participants will be offered the developed lifestyle intervention strategy.
In case of a medical condition, like hypertension or diabetes,
pharmacotherapeutic treatment will be applied by protocol.
Study burden and risks
Participants visit the outpatient clinic 7 times during 14 months. 6 visits
will consist of venapuncture, weighting and measurement of the participant. 1
visit will consist of feedback. During 3 visits a questionnaire concerning
lifestyle will be filled in by the participant.
The lifestyle intervention strategy must yet be developed. It might consist of
some extra visits to the outpatient clinic.
Dr. Molenwaterplein 40
3015 GD Rotterdam
Nederland
Dr. Molenwaterplein 40
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Recently given birth
*=< 6 weeks postpartum
The recent pregnancy was complicated by at least one of the following aspects:
*Preeclampsia
**bloodpressure >= 140/90 mmHg and
**proteinuria >= 0,3 gr/24 hours and
**gestational age at time of diagnosis >= 20 weeks
*intrauterine growth restriction due to placental insufficiency
**abdominal circumference <5th percentile and
**pathological doppler velocity pattern in umbilical artery
***pulsatility index > 95th percentile or
***absent or reversed enddiastolic flow
*gestational diabetes
**2 hours post-load (75 gr) glucose > 7,8 mmol/l
age at delivery >= 18 years
be master of dutch spoken and written language
Exclusion criteria
preexisting pathology, before indexpregnancy
*kidneydisease
*type 1 and 2 diabetes mellitus
*diagnosed with ischemic cardiovascular disease
*diagnosed with congenital heartdefect without hemodynamic consequences
intrauterine growth restriction, not due to placental insufficiency
*intrauterine infection
*congential malformations
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11603.078.06 |