MBL Level in Women With Recurrent Miscarriage and Its Association With Perinatal Outcome

Brief Title

Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)

Official Title

Low Plasma MBL Level is a Risk Factor for Recurrent Pregnancy Loss

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.
    

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 females of
      reproductive age. The underlying cause of RPL remain unknown in up to 50% of cases. Some of
      these cases may be affected by an aberrant immune system.

      Low p-MBL levels have been associated with RPL, while relations to high levels have been
      poorly studied. Reports concerning association between maternal p-MBL levels and perinatal
      outcomes including birth weight and gestational age are conflicting. Low MBL level may
      possess a negative effect by 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. The study group includes 267 women with RPL. P-MBL levels in patients is
      compared to those of 185 female blood donors of fertile age with unknown reproductive
      history, while their perinatal outcomes is compared to all singleton births at Aalborg
      University Hospital (DK) in 2017.

      Female patients in the study group will have a blood sample taken at their first meeting in
      the the Centre for Recurrent Pregnancy Loss of Western Denmark before they become pregnant,
      and they will be followed until delivery of the first child after RPL, if pregnancy after RPL
      is achieved, or until end of study. Data on perinatal outcomes of singleton pregnancies
      before and after RPL were collected at the first consultation, from hospital records, and,
      when needed, completed by telephone or e-mail correspondence.
    


Study Type

Observational


Primary Outcome

Plasma MBL Level (ug/ml)

Secondary Outcome

 Participants Giving Birth After Recurrent Pregnancy Loss (RPL) to a Child With Low Birth Weight

Condition

Recurrent Miscarriage


Study Arms / Comparison Groups

 Study sample
Description:  Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.
111 gave birth before RPL and 139 gave birth after RPL.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

452

Start Date

July 8, 2019

Completion Date

August 29, 2020

Primary Completion Date

March 1, 2020

Eligibility 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
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Caroline Nørgaard-Pedersen, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04017754

Organization ID

36e19au5


Responsible Party

Principal Investigator

Study Sponsor

Aalborg University Hospital


Study Sponsor

Caroline Nørgaard-Pedersen, Principal Investigator, Aalborg University Hospital


Verification Date

January 2021