Trial Outcomes & Findings for Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL) (NCT NCT04017754)

NCT ID: NCT04017754

Last Updated: 2021-07-30

Results Overview

Manose Binding Lectin level in a blood sample

• Recruitment status: COMPLETED
• Target enrollment: 452 participants
• Primary outcome timeframe: At first consultation. Results accessible within 3 weeks.
• Results posted on: 2021-07-30

Participant Flow

The study sample consisted of 267 female patients with RPL fulfilling the inclusion criterias.

Participant milestones

Measure	Study Sample 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	Control Group 1 The MBL control group comprised 185 Danish female blood donors of reproductive age (range 21 to 45 years), about whom we have no other information than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Overall Study STARTED	267	185
Overall Study COMPLETED	267	185
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Sample n=267 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	267 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.2 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	267 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	267 participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants
Region of Enrollment Denmark	267 participants n=5 Participants
Body mass index	25.4 kg/m² n=5 Participants
Number of consecutive pregnancy losses	3 consecutive pregnancy losses n=5 Participants
Percentage with primary Recurrent pregnancy loss (RPL)	53.9 Percentage of all RPL patients n=5 Participants

PRIMARY outcome

Timeframe: At first consultation. Results accessible within 3 weeks.

Population: 18 women were pregnant \<12 weeks when blood sample was collected.

Manose Binding Lectin level in a blood sample

Outcome measures

Measure	Study Sample n=267 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=185 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Plasma MBL Level (ug/ml)	717 ug/l Interval 164.0 to 2131.0	1717 ug/l Interval 505.0 to 3528.0

SECONDARY outcome

Timeframe: at delivery

Population: Patients who have given birth after admission within each p-MBL level subgroup

<2500g

Outcome measures

Measure	Study Sample n=76 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=21 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants Giving Birth After Recurrent Pregnancy Loss (RPL) to a Child With Low Birth Weight	3 participants	1 participants

SECONDARY outcome

Timeframe: At first consultation

Population: participants who had sRPL; thus, who had given birth before admission to at least one child. Data concerns first delivery.

<2500g

Outcome measures

Measure	Study Sample n=51 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=25 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants Giving Birth Before RPL to a Child With Low Birth Weight	4 participants	2 participants

SECONDARY outcome

Timeframe: at delivery

<1500g

Outcome measures

Measure	Study Sample n=76 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=21 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants Giving Birth After RPL to a Child With Very Low Birth Weight	0 participants	0 participants

SECONDARY outcome

Timeframe: At first consultation

<1500g

Outcome measures

Measure	Study Sample n=51 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=25 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants Giving Birth Before RPL to a Child With Very Low Birth Weight	0 Participants	0 Participants

SECONDARY outcome

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

High blood pressure and proteinuria

Outcome measures

Measure	Study Sample n=79 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants With Preclampsia in Pregnancy After RPL	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Developed from 20 weeks gestation and until 6 weeks postpartum. Data collected at first consultation.

High blood pressure and proteinuria

Outcome measures

Measure	Study Sample n=51 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=25 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Participants With Preclampsia in Pregnancy Before RPL	6 Participants	2 Participants

SECONDARY outcome

Timeframe: at delivery

A surgical delivery in women who were planned for vaginal delivery initially, but an acute indication for caesarean delivery has since developed.

Outcome measures

Measure	Study Sample n=79 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=22 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Emergency Caesarean Section After RPL	10 Participants	4 Participants

SECONDARY outcome

Timeframe: At first consultation

A surgical delivery in women who were planned for vaginal delivery initially, but an acute indication for caesarean delivery has since developed

Outcome measures

Measure	Study Sample n=53 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=24 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Emergency Caesarean Section Before RPL	12 Participants	6 Participants

SECONDARY outcome

Timeframe: at delivery

A surgical delivery in women who were planned for caesarean delivery

Outcome measures

Measure	Study Sample n=79 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=22 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Elective Caesarean Section After RPL	13 Participants	3 Participants

SECONDARY outcome

Timeframe: At first consultation

A surgical delivery in women who were planned for caesarean delivery

Outcome measures

Measure	Study Sample n=53 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=24 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Elective Caesarean Section Before RPL	6 Participants	0 Participants

SECONDARY outcome

Timeframe: During delivery

Hemorrhage of >999 ml

Outcome measures

Measure	Study Sample n=78 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Severe Peripartum Hemorrhage in Birth After RPL	6 Participants	3 Participants

SECONDARY outcome

Timeframe: At first consultation

Hemorrhage of >999 ml in minimum one previous birth befor RPL

Outcome measures

Measure	Study Sample n=45 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=21 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Severe Peripartum Hemorrhage in Birth Before RPL	8 Participants	0 Participants

SECONDARY outcome

Timeframe: During delivery

Hemorrhage of 500-1000 ml

Outcome measures

Measure	Study Sample n=78 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Moderate Peripartum Hemorrhage in Birth After RPL	21 Participants	2 Participants

SECONDARY outcome

Timeframe: At first consultation

Hemorrhage of 500-1000 ml in minumum one previous birth before RPL

Outcome measures

Measure	Study Sample n=45 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=21 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With Moderate Peripartum Hemorrhage in Birth Before RPL	6 Participants	6 Participants

SECONDARY outcome

Timeframe: at delivery

<37 weeks of gestation

Outcome measures

Measure	Study Sample n=78 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=22 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Preterm Birth in Birth After RPL	8 Participants	3 Participants

SECONDARY outcome

Timeframe: At first consultation

<37 weeks of gestation

Outcome measures

Measure	Study Sample n=49 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Preterm Birth in Birth Before RPL	4 Participants	1 Participants

SECONDARY outcome

Timeframe: at delivery

<32 weeks of gestation

Outcome measures

Measure	Study Sample n=78 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=21 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Very Preterm Birth in Birth After RPL	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At first consultation

<32 weeks of gestation

Outcome measures

Measure	Study Sample n=49 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Very Preterm Birth in Birth Before RPL	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At delivery

Population: male:female ratio

Gender ratio in births before RPL

Outcome measures

Measure	Study Sample n=79 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Gender Ratio of Children Born After RPL	1.08 male:female ratio	2.29 male:female ratio

SECONDARY outcome

Timeframe: At first consultation

Gender ratio in births after RPL

Outcome measures

Measure	Study Sample n=47 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Gender Ratio of Children Born Before RPL	3.27 male:female ratio	1.88 male:female ratio

SECONDARY outcome

Timeframe: 1 week after delivery

Stillbirth are defined as fetal death >22 weeks of gestation and within 1 week after delivery

Outcome measures

Measure	Study Sample n=79 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=23 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Stillbirth After RPL	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At first consultation

Stillbirth are defined as fetal death >22 weeks of gestation and within 1 week after delivery - all women with min one previous birth are included in this analysis.

Outcome measures

Measure	Study Sample n=54 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=26 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Stillbirth Before RPL	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Follow up at study end.

Number of women who give birth to a healthy liveborn child after RPL

Outcome measures

Measure	Study Sample n=119 Participants 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. At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases.	MBL Reference Group n=46 Participants 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 than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
Patients With a Liveborn After RPL	79 Participants	23 Participants

Adverse Events

Study Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caroline Nørgaard-Pedersen

Aalborg University Hospital, Gynecologic and Obstetric department

Phone: +45 41120267

Email: carolinenp94@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place