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van CCT (UK)

van CCT (UK)

Recurrent miscarriages: Causes, treatment and consequences.

- candidate number10449
- NTR NumberNTR3107
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-okt-2011
- Secondary IDs 
- Public TitleRecurrent miscarriages: Causes, treatment and consequences.
- Scientific TitleRecurrent miscarriages: Causes, treatment and consequences.
- ACRONYMAbortion
- hypothesisThe fetus is protected from maternal immune responses through various mechanisms such as lack of expression of classical HLA class I and class II molecules, inhibitory T cell, costimulatory molecules, NK cells, complement regulatory proteins by trophoblasts, and by local maternal regulatory T cells.
We hypothesize that an imbalance between immunomodulatory and effector cells and as a consequence an inadequate cytokine production could be responsible for recurrent miscarriage. This study will include couples with recurrent miscarriages. A prospective study will be performed during the following pregnancy by taking peripheral blood samples, which will be stimulated with paternal, third party (unrelated PBMCs) and, if available cord blood cells expressing HLA-antigens, and monitored for cell proliferation, cytokine production, antibodies and complement activation to determine the difference between ongoing pregnancies and miscarriages.
- Healt Condition(s) or Problem(s) studiedRecurrent miscarriages, Trombophilia, Antiphospholipid syndrome
- Inclusion criteria1. > two subsequently miscarriages;
2. Maternal age < 40.
- Exclusion criteria1. Parental chromosomal abnormalities;
2. Uterus anomalies;
3. Cervical insufficiency;
4. Untreated thyroid disease;
5. Patient mentally or legally incapacity;
6. Any history of/ or recent alcohol or drug abuse;
7. Poor balance or treatment of diabetes mellitus;
8. ART (assisted reproductive technology) pregnancies.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate1-jan-2014
- Target number of participants60
- InterventionsN/A
- Primary outcomePregnancy outcome.
- Secondary outcome1. To describe maternal immune responses in women with miscarriages compared to women with an ongoing pregnancy and women with a normal pregnancy at different gestational periods;
2. To research which role medication (progesteron, anticoagulantia) plays in the immune response and pregnancy outcome;
3. To research whether specific KIR genes combined with specific HLA-C ligands determines or influences pregnancy outcome;
4. To research the presence of KIR and KAR on NK cells, and their effect on cytokine profiles during pregnancy and pregnancy outcome;
5. To research whether the proportion of Th1 cells compared to the proportion of Th2 cells influences pregnancy outcome;
6. To study the presence of C4d deposition in placental tissue in patients with recurrent miscarriage in relation to the presence of autoantibodies, allo-antibodies and to pregnancy outcome;
7. To determine whether cytokines, chemokines or sHLA-1 in sperm influences pregnancy outcomes.
- Timepoints01-12-2011: Start recruiting couples at miscarriage clinic;
01-03-2012: Start first labexperiments;
01-01-2013: Start analyzing results;
01-01-2014: Finishing study.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of OC&W, NVLE (Nationale vereniging voor lupus, sclerodermie en MCTD)
- PublicationsN/A
- Brief summaryWith 1 to 2% of the couples suffering from recurrent miscarriages, prevention would be of undisputable benefit for couples who suffer from recurrent miscarriages on a medical as well as psychological point of view. Understanding mechanisms triggering the maternal immune system in more detail, especially at the maternal-fetal interface, could help to elucidate mechanism behind recurrent miscarriages. An inadequate peripheral maternal immune response against paternal antigens may lead to improper implantation and rejection of the embryo. Both HLA genes and cytokines have been studied extensively in women with recurrent miscarriages. So far no study has focussed on the specific immune response and cytokine production by maternal PMBCs to paternal or umbilical cord cells in couples with recurrent miscarriage. The outcome of these functional studies will be related to HLA analysis of both partners and the newborn. Hopefully these results will give us new insights and possibilities for development of various treatments.
- Main changes (audit trail)
- RECORD18-okt-2011 - 26-okt-2011

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