N/A
Completed 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
Source: ClinicalTrials.gov NCT04017754 ↗
Enrolled (actual)
452
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Plasma MBL Level (ug/ml) — 717; 1717 ug/l — p=<0.001
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.
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 | — |
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. Informational only — not medical advice.