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

NCT04017754 | Completed Results

• 1 other identifier: 36e19au5
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Miscarriage; Spontaneous Abortion; Mannose-Binding Lectin Deficiency; Habitual Abortion; Pregnancy Complications; Pregnancy Loss; Recurrent Pregnancy Loss

Keywords

Mannose binding lectin; Perinatal outcome; Recurrent pregnancy loss

Outcome Measures

Primary Outcomes (1)

• Plasma MBL Level (ug/ml)

  Manose Binding Lectin level in a blood sample

  At first consultation. Results accessible within 3 weeks.

Secondary Outcomes (23)

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

  at delivery

• Participants Giving Birth Before RPL to a Child With Low Birth Weight

  At first consultation

• Participants Giving Birth After RPL to a Child With Very Low Birth Weight

  at delivery

• Participants Giving Birth Before RPL to a Child With Very Low Birth Weight

  At first consultation

• Participants With Preclampsia in Pregnancy After RPL

  Developed from 20 weeks gestation and until 6 weeks postpartum. Data collected at delivery.

Study Arms (2)

Study sample

In total, 267 women with unexplained recurrent pregnancy loss was included. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses are included. Both biochemical and clinical losses documented in hospital records are accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social reasons are 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.

Reference Group

The MBL reference group comprised 185 Danish female blood donors of reproductive age (range 21 to 45 years), about whom we have no other information. After informed approval, all controls had an extra blood sample taken, which was analysed for p-MBL.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female women of reproductive age.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women fulfilling the eligibility criteria will have p-MBL level measured from a blood sample when first admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark and will be followed until delivery of the first child following the consecutive pregnancy losses, if pregnancy is achieved during the study period.

You may qualify if:

• \- Women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark January 2016 to March 2020

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Norgaard-Pedersen C, Rom LH, Steffensen R, Kesmodel US, Christiansen OB. Plasma level of mannose-binding lectin is associated with the risk of recurrent pregnancy loss but not pregnancy outcome after the diagnosis. Hum Reprod Open. 2022 Jun 7;2022(3):hoac024. doi: 10.1093/hropen/hoac024. eCollection 2022.

  PMID: 35747402 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples from the female patients and blood donors

MeSH Terms

Conditions

Abortion, Habitual; Abortion, Spontaneous; Mannose-Binding Protein Deficiency; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

161 (60.3 %) patients gave birth after RPL during the study period, which limited the possibility to detect clear associations between p-MBL levels and perinatal outcomes after RPL.

Results Point of Contact

• Title: Caroline Nørgaard-Pedersen
• Organization: Aalborg University Hospital, Gynecologic and Obstetric department

carolinenp94@gmail.com

+45 41120267

Study Officials

• Caroline Nørgaard-Pedersen

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: January 1, 2016
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: July 30, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-07

Locations

DK (1)