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Recurrent miscarriages and the subsequent risk of cardiovascular disease.


- candidate number12290
- NTR NumberNTR3408
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2012
- Secondary IDs40524 ABR
- Public TitleRecurrent miscarriages and the subsequent risk of cardiovascular disease.
- Scientific TitleRecurrent miscarriages and the subsequent risk of cardiovascular disease.
- ACRONYMREMI-C
- hypothesisThere is increasing evidence that women with hypertension or preeclampsia during pregnancy are at increased of cardiovascular diseases later in life compared to women with normotensive pregnancies. As suggested by previous studies, placenta insufficiency syndrome maybe a first sign of cardiovascular disease, which could also be true for recurrent miscarriages.
- Healt Condition(s) or Problem(s) studiedRecurrent miscarriage, Cardiovascular disease
- Inclusion criteriaWomen who visited the recurrent miscarriages clinic since 2000. The time interval between their first miscarriage and the time of inclusion has to be at least 2 years.
The control group will be derived from the Hyras study. The controls were required to have one or more uncomplicated pregnancy (ies) in their history.
- Exclusion criteriaLactating and pregnant (within the last 3 months) women.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jun-2012
- planned closingdate1-jun-2014
- Target number of participants405
- InterventionsAssessment of classic cardiovascular risk factors will be performed for women with recurrent miscarriages vs women with an uncomplicated pregnancy in history.
- Primary outcome1. Blood pressure;
2. Body mass index;
3. Venous blood sampled: Glucose, HbA1c, insulin, total cholesterol, HDL cholesterol, triglycerides and HsCRP;
4. Urine: Microalbumin.
- Secondary outcomeCardiovascular risk profile.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.M. Wagner
- CONTACT for SCIENTIFIC QUERIESDr. K.W.M. Bloemenkamp
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryRecurrent miscarriages is commonly defined as three or more consecutive miscarriages prior to the 20th week. It is a common problem affecting 1 to 2% of all fertile couples and is a highly heterogeneous condition. An underlying cause may be identified in about 25-50% of cases.
There is increasing evidence that women with hypertension or preeclampsia during pregnancy are at increased of cardiovascular diseases later in life compared to women with normotensive pregnancies. As suggested by previous studies, placenta insufficiency syndrome maybe a first sign of cardiovascular disease, which could also be true for recurrent miscarriages.
Identifying women with risk factors for cardiovascular diseases as early as possible makes it possible for them to benefit from preventive interventions.
- Main changes (audit trail)
- RECORD1-mei-2012 - 6-mei-2012


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