Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)
Low Plasma MBL Level is a Risk Factor for Recurrent Pregnancy Loss
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.
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.
Plasma MBL Level (ug/ml)
Participants Giving Birth After Recurrent Pregnancy Loss (RPL) to a Child With Low Birth Weight
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
July 8, 2019
August 29, 2020
Primary Completion Date
March 1, 2020
- Women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark since 2016
- 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
18 Years - 45 Years
Accepts Healthy Volunteers
Caroline Nørgaard-Pedersen, ,
Aalborg University Hospital
Caroline Nørgaard-Pedersen, Principal Investigator, Aalborg University Hospital