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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
Sponsor:
Information provided by (Responsible Party):
Caroline Nørgaard-Pedersen, Aalborg University Hospital

Brief Summary:
The present study is based on the hypothesis, that recurrent pregnancy loss (RPL) is associated with abnormal mannose binding lectin (MBL) plasma level. Secondarily, MBL plasma level may affect the perinatal outcome in the first pregnancy following RPL. Thus, the present study aim to examine whether MBL should be a biomarker for women at risk for RPL and, secondarily, perinatal complications, and consequently help identify fragile women who need intensified perinatal care.

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.

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study sample
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.

Control group
Danish female blood donors of reproductive age with unknown reproductive history.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Low birth weight [ Time Frame: at delivery ]
    <2500g

  2. Very low birth weight [ Time Frame: at delivery ]
    <1500g

  3. Preeclampsia [ Time Frame: Developed from 20 weeks gestation and until 6 weeks postpartum ]
    High blood pressure and proteinuria

  4. 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

  5. Peripartum hemorrhage [ Time Frame: at delivery ]
    Hemorrhage of >999ml

  6. Preterm birth [ Time Frame: at delivery ]
    <37 weeks of gestation

  7. Very preterm birth [ Time Frame: at delivery ]
    <32 weeks of gestation


Biospecimen Retention:   Samples Without DNA
Blood samples from the female patients and blood donors


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female women of reproductive age.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women fulfilling the eligibility criteria had measured MBL plasma level from a blood sample when first admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark and were followed until delivery of the first child following the consecutive pregnancy losses, if pregnancy was achieved.
Criteria

Inclusion Criteria:

- Women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark since 2016

Exclusion Criteria:

  • Less than 3 consecutive pregnancy losses
  • Significant uterine malformation on hydrosonography or hysteroscopy
  • Significant chromosomal abnormalities
  • Abnormal menstrual cycle (<22 or >35 days)
  • Pregnancy at first meeting in the Recurrent Miscarriage Clinic
  • Age <18 and >45 years

Information from the National Library of Medicine

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


Contacts
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Contact: Caroline Nørgaard-Pedersen 0045 41120267 c.noergaardpedersen@rn.dk
Contact: Ole Bjarne Christiansen olbc@rn.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Ole Bjarne Christiansen       olbc@rn.dk   
Sponsors and Collaborators
Caroline Nørgaard-Pedersen
Investigators
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Principal Investigator: Caroline Nørgaard-Pedersen Aalborg University Hospital

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Responsible Party: Caroline Nørgaard-Pedersen, Medical student, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04017754     History of Changes
Other Study ID Numbers: 36e19au5
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Caroline Nørgaard-Pedersen, Aalborg University Hospital:
Mannose binding lectin
Perinatal outcome
Recurrent pregnancy loss

Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Fetal Death
Abortion, Habitual
Metabolism, Inborn Errors
Death
Pathologic Processes
Genetic Diseases, Inborn
Metabolic Diseases