MBL Level in Women With Recurrent Miscarriage and Its Association With Perinatal Outcome
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|ClinicalTrials.gov Identifier: NCT04017754|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment|
|Recurrent Miscarriage Spontaneous Abortion Mannose-Binding Lectin Deficiency Habitual Abortion Pregnancy Complications Pregnancy Loss Recurrent Pregnancy Loss||Other: Investigate the association of MBL plasma levels with RPL and perinatal outcome before and after RPL.|
Recurrent pregnancy loss (RPL), defined as 3 or more consecutive pregnancy losses before 22 weeks of gestation, is a multifactorial disorder, affecting 1-3% of all couples aiming to have a child. The cause of RPL remain unknown in up to 50% of cases. Some of these cases may be affected by an aberrant immune system. Low levels of mannose binding lectin (MBL) in plasma have been associated with RPL, chorioamnionitis, and low birth weight, while high MBL levels have been associated with pro-inflammatory properties resulting in preterm labor and preeclampsia.
Previous studies of MBL have proposed that high and low plasma levels, both may possess a negative effect by priming or promoting an aggressive immune response resulting in autoimmunity and tissue damage.
This study is a single center case-control study and historical cohort study, that aims to investigate wether high and/or low MBL plasma levels are associated with RPL (primary outcome) and whether it affects perinatal outcome in the first pregnancy following the RPL and pregnancy outcome from before RPL in women with secondary RPL (secondary outcome). Thus, if such association exists, MBL could become an biomarker for the early identification of women with need for intensified perinatal care.
The study sample consists of Danish women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark and the control group consists of Danish female blood donors of fertile age with unknown reproductive history. The study sample and control group target about 350 women, each.
Female patients in the study sample will have a blood sample taken at their first meeting in the Recurrent Miscarriage Center before they become pregnant, and they will be followed until delivery of the first child after RPL, if pregnancy after RPL is achieved. Data of perinatal outcome will be collected from hospital records.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Mannose Binding Lectins (MBL) Plasma Level in Women With Recurrent Pregnancy Loss and Whether it Influences the Pregnancy Outcome|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Women with unexplained recurrent pregnancy loss.
Other: Investigate the association of MBL plasma levels with RPL and perinatal outcome before and after RPL.
A single blood sample at first hospital meeting in the Centre for Recurrent Pregnancy Loss of Western Denmark and a follow up in hospital records for secondary outcome.
Danish female blood donors of reproductive age with unknown reproductive history.
- MBL plasma level (ug/ml) [ Time Frame: at first consultation when the woman is not pregnant. Results accessible within 1 week. ]Manose Binding Lectin level in a blood sample
- Low birth weight [ Time Frame: at delivery ]<2500g
- Very low birth weight [ Time Frame: at delivery ]<1500g
- Preeclampsia [ Time Frame: Developed from 20 weeks gestation and until 6 weeks postpartum ]High blood pressure and proteinuria
- Emergency caesarean section [ Time Frame: at delivery ]A surgical delivery in women who were planned for vaginal delivery initially, but an acute indication for caesarean delivery has since developed
- Peripartum hemorrhage [ Time Frame: at delivery ]Hemorrhage of >999ml
- Preterm birth [ Time Frame: at delivery ]<37 weeks of gestation
- Very preterm birth [ Time Frame: at delivery ]<32 weeks of gestation
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017754
|Contact: Caroline Nørgaard-Pedersen||0045 email@example.com|
|Contact: Ole Bjarne Christiansenfirstname.lastname@example.org|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Ole Bjarne Christiansen email@example.com|
|Principal Investigator:||Caroline Nørgaard-Pedersen||Aalborg University Hospital|