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PreCare

 

Cost-effectiveness of recurrence risk-guided care of pregnant women with preeclampsia or HELLP in the previous pregnancy.

 

Go to the PreCare website.

 

Objective

Objective of the PreCare study is to assess the cost-effectiveness of recurrence-risk guided care versus care as usual in pregnant women who suffered from preeclampsia or HELLP in their first pregnancy.

 

Study design

The PreCare study is a partly retrospective and partly prospective multicenter cohort study. For the economic evaluation, a modeling approach will be used.

 

Study population

The study population will consist of pregnant women with preeclampsia/ HELLP in their previous pregnancy, who will be recruited in five academic hospitals and one large non-academic referral hospital. We aim to include approximately 250 patients in our study (recurrence-risk guided follow-up arm).

 

Inclusion criteria

1. Presentation before 17 weeks’ gestation;

2. Preeclampsia or HELLP diagnosed in the previous pregnancy;

3. Measurements between 3-9 months postpartum, of at least HOMA-IR, MAP and HDL;

4. Informed consent.

 

Exclusion criteria

1. Maternal age <18 year;

2. Diabetes Mellitus;

3. Systemic Lupus Erythematodes (SLE);

4. Renal disease;

5. Cardiac disease;

6. Antiphospholipid Syndrome.

  

Intervention

The intervention in the PreCare study is the referral to either High Care (HC) or Medium Care (MC), depending on predicted risks of developing severe preeclampsia/ HELLP or delivery of an infant with extremely low birth weight. HC comprises 17 visits to the outpatient clinic, ultrasonographic fetal biometry during each visit, additional diagnostics in weeks 12, 16 and 20, and the possibility of a 1-week in-hospital diagnostic stage. MC consists of 11 visits accompanied by fetal biometry, and no additional diagnostics.

 

Outcome measures

Primary outcome measure is the occurrence of either severe preeclampsia or HELLP (requiring delivery before 34 weeks) or delivery of an infant with extremely low birth weight (<1250 g) among women in the MC group. Secondary outcome measures are timing and occurrence of preeclampsia, eclampsia or HELLP, IUGR, caesarian section, admission to NICU, pregnancy duration, maternal/ infant mortality, societal costs, QoL, anxiety, depression, posttraumatic stress, satisfaction with treatment and non-compliance.

 

Economic evaluation

Costs and effects of recurrence-risk guided care and care-as-usual will be compared by means of a decision model. Two incremental cost-effectiveness ratios will be calculated: 1) cost per Quality Adjusted Life Year (mother is the unit of analysis) and 2) cost per live born child (child is the unit of analysis).

 

Time schedule

Total duration: 36 months; 3 months preparation, 21 months inclusion, measurements, cea-model development and validation, 9 months measurements, completion follow-up, cea-model input, update of prediction model (if necessary), 3 months final data-analysis and reporting. Care-as-usual measurements have started in august 2008; the referral to either MC or HC groups will start early in 2009.

 

Project leader

Dr. L. Smits (MUMC+, dept. Epidemiology)

 

Senior researchers

Dr. L. Peeters (MUMC+, dept. Obstetrics and Gynecology)

Dr. C Dirksen (MUMC+, dept. Clinical Epidemiology and Medical Technology Assessment)

 

Junior researcher

Drs. S. Sep (MUMC+, depts. Obstetrics and Gynecology and Epidemiology)

 

PhD students

Drs. D. Delahaije (MUMC+, depts. Obstetrics and Gynecology and Clinical Epidemiology and Medical Technology Assessment)

Drs. S. van Kuijk (MUMC+, depts. Obstetrics and Gynecology and Epidemiology)

 

Subsidy

ZonMw – www.zonmw.nl