In order to achieve these objectives, clinical data and blood sample results obtained through the MUHC LEGACY Biobank (directed by Dr. Evelyne Vinet) will be analysed. The objective of the LEGACY Biobank (the "Bank") is the conservation of blood samples; more specifically, plasma, sera, and crude white cell pellet and clinical data ("material/data") collected from an international multi-centre prospective cohort of pregnant women with systemic lupus erythematosus (SLE).

Systemic Lupus Erythematosus

Pregnancy Complications

James G, Witten D, Hastie T, Tibshirani R. An Introduction to Statistical Learning—With Applications in R. New York: Springer; 2013.

McGill University Health Centre

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Fetal death, neonatal death, preterm delivery or termination of pregnancy, and small for gestational age neonate confirmed by chart review and autopsy report.

The Adherence to Refills and Medications Scale (ARMS), a validated self-reported questionnaire developed for patients with chronic disease with low literacy, measures ASA adherence. A self-reported aspirin adherence questionnaire consisting of 3 to 6 questions about the use of aspirin during current pregnancy measures ASA use. A visual analogue scale from 0 to 10 measures frequency of ASA ingestion. Change in ASA use will be measured by the questionnaires. Frequencies of dosage of ASA will also be measured.

Baseline covariates such as lupus anticoagulant antibodies, a subtype of anticoagulant antibodies, Antiphosphatidylserine/prothrombin antibodies (aPS/PT), antihypertensive use, disease activity, platelet levels will be measured and defined by the physician-in-charge. Nephritis history, race/ethnicity, nulliparity, maternal age, pre-gestational diabetes, obsesity (BMI above 30) and medication use (corticosteroids, antimalarials, immunosuppressive and low-dose aspirin) will be characterized.
Measures for disease activity include the SLE Pregnancy Disease Activity Index (SLEPDAI), a widely-recognized adaptation of the validated SLE Disease Activity Index, reflects disease activity in pregnancy context.

Positive results for Antiphosphatidylserine/prothrombin antibodies (aPS/PT) and and lupus anticoagulant results in pregnant women with SLE with and without adverse pregnancy outcomes

Information will be kept between investigators.

Evelyne Vinet

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Duke University

University of California, Los Angeles

Dalhousie University

Hanyang University

Hospital for Special Surgery, New York

Johns Hopkins University

Monash University

New York University

Oklahoma Medical Research Foundation

University of North Carolina

Temple University

University of Alabama at Birmingham

University of Birmingham

University of Calgary

University of California

University of Copenhagen

University of Manitoba

University of Michigan

University of Toronto

NYU Langone Health

University of British Columbia

National Institute of Medical Science & Nutrition

Laval University

University Health Network, Toronto

W&D should begin when participants wish to conceive. The intervention was standardized by training of research staff. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.

No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.

The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention

Walking & Dietary Modification (W&D)

Controls

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Normal or underweight (BMI <25 kg/m2)

Owerweight (BMI 25–30 kg/m2)

Obese (BMI > 30 kg/m2)

Type 1 diabetes mellitus

Chronic hypertension

Women with live offspring

The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention

Take-home Baby Rate

The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention

Gestational Diabetes Mellitus

Preeclampsia

Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency

Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers

Excessive Weight Gain

First-trimester Losses

Second and Third-trimester Losses

Live-born Children

Babies Born at Term

Appropriate-for-gestational Age Babies

Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.

Neonates With Hypoglycemia

Overall Study

Dr. Silvia Hoirisch-Clapauch

The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention

Recurrent Miscarriage

Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those remaining seated most of the day should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, which often occurred near term and when the mother was obese.
At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants are recommended to use ondansetron for nausea and vomiting prevention

Walking & dietary modification

Hospital Federal dos Servidores do Estado, Ministry of Health

Walking and Dietary Modification for Recurrent Early Miscarriages

Walking and Dietary Modification for Women With Consecutive Early Miscarriages: a Randomized Study

Silvia Hoirisch Clapauch

Hospital dos Servidores do Estado do Rio de Janeiro

Participants were not blinded, but visits of the two groups were scheduled so as to not coincide..

placental insufficiency/дебелина

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Walking and Dietary Modification for Recurrent Early Miscarriages

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