N/A
N=452
Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)
Recurrent Miscarriage · Spontaneous Abortion · Mannose-Binding Lectin Deficiency · Habitual Abortion · Pregnancy Complications
Bottom Line
View on ClinicalTrials.gov: NCT04017754 ↗Enrolled (actual)
452
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Plasma MBL Level (ug/ml) — 717; 1717 ug/l — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aalborg University Hospital
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma MBL Level (ug/ml) |
717; 1717 | <0.001 sig |
| SECONDARY Participants Giving Birth After Recurrent Pregnancy Loss (RPL) to a Child With Low Birth Weight |
3; 1 | — |
| SECONDARY Participants Giving Birth Before RPL to a Child With Low Birth Weight |
4; 2 | — |
| SECONDARY Participants Giving Birth After RPL to a Child With Very Low Birth Weight |
0; 0 | — |
| SECONDARY Participants Giving Birth Before RPL to a Child With Very Low Birth Weight |
0; 0 | — |
| SECONDARY Participants With Preclampsia in Pregnancy After RPL |
7; 0 | — |
| SECONDARY Participants With Preclampsia in Pregnancy Before RPL |
6; 2 | — |
| SECONDARY Patients With Emergency Caesarean Section After RPL |
10; 4 | — |
| SECONDARY Patients With Emergency Caesarean Section Before RPL |
12; 6 | — |
| SECONDARY Patients With Elective Caesarean Section After RPL |
13; 3 | — |
| SECONDARY Patients With Elective Caesarean Section Before RPL |
6; 0 | — |
| SECONDARY Patients With Severe Peripartum Hemorrhage in Birth After RPL |
6; 3 | — |
| SECONDARY Patients With Severe Peripartum Hemorrhage in Birth Before RPL |
8; 0 | — |
| SECONDARY Patients With Moderate Peripartum Hemorrhage in Birth After RPL |
21; 2 | — |
| SECONDARY Patients With Moderate Peripartum Hemorrhage in Birth Before RPL |
6; 6 | — |
| SECONDARY Patients With a Preterm Birth in Birth After RPL |
8; 3 | — |
| SECONDARY Patients With a Preterm Birth in Birth Before RPL |
4; 1 | — |
| SECONDARY Patients With a Very Preterm Birth in Birth After RPL |
2; 0 | — |
| SECONDARY Patients With a Very Preterm Birth in Birth Before RPL |
0; 0 | — |
| SECONDARY Gender Ratio of Children Born After RPL |
1.08; 2.29 | — |
| SECONDARY Gender Ratio of Children Born Before RPL |
3.27; 1.88 | — |
| SECONDARY Patients With a Stillbirth After RPL |
0; 0 | — |
| SECONDARY Patients With a Stillbirth Before RPL |
4; 3 | — |
| SECONDARY Patients With a Liveborn After RPL |
79; 23 | — |
Summary
The present study is based on the hypothesis, that recurrent pregnancy loss (RPL) is associated with abnormal plasma mannose binding lectin (p-MBL) level. Secondarily, p-MBL level may affect the reproductive and 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, affect the reproductive and perinatal outcome, and thereby help clinicians identify fragile women who need intensified perinatal care.
Eligibility Criteria
Inclusion Criteria
- Women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark January 2016 to March 2020
Exclusion Criteria
- Less than 3 consecutive pregnancy losses
- Significant uterine malformation on hydrosonography or hysteroscopy
- Significant chromosomal abnormalities
- Abnormal menstrual cycle length ( 35 days) or irregular cycle
- Pregnancy at first meeting in the Recurrent Miscarriage Clinic
- Age 45 years
Data sourced from ClinicalTrials.gov (NCT04017754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.