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Examining outcomes beyond 20 weeks gestational age in pregnancies conceived by ART compared to spontaneously conceived pregnancies
The research literature from other study populations suggest the prevalence of pregnancy complications are higher amongst women with ART-treated deliveries. Specifically, there is a trend towards higher rates of gestational diabetes, pregnancy induced hypertension, premature deliveries, low birthweight deliveries, perinatal deaths and maternal length of stay in hospital after delivery. The challenge lies in determining the degree of difference and the trend.
Given the relatively older age of conception in BC, the investigators hypothesize that the aforementioned complications may in fact be higher in both the spontaneous conception and ART-treated groups. That being said, the investigators suspect the ART group is likely to still have a higher rates of gestational diabetes, hypertension, premature deliveries, low birthweight, and miscarriages.
The investigators intend to conduct a retrospective cohort study examining differences in pregnancy outcomes after 20 weeks GA in ART-treated versus fertile women.
The study population will consist of women in BC with in-province deliveries occurring between March 1 2008 and April 31 2018 that resulted in singleton live birth or fetal death at >20 weeks. Only fertile women conceiving their index pregnancy by assisted reproductive technology (ART) will be included. Multiparous women and women with multiple gestation deliveries will be excluded. Also, any women missing data including gravida, parity, age, date of birth, neonatal birth weight, neonatal APGARs, neonatal live birth versus stillbirth Data will be collected from the perinatal services BC database, following approval. A biostatistician will be employed to help utilize the data requested.
Obstetric and Fetal outcome measures of prematurity (<37 weeks GA), low birthweight (<2500g), small for gestational age (in live births), perinatal death (fetal death >20 weeks to death of newborn up to 7 days post-delivery), prolonged maternal length of stay in hospital following delivery (>3 days), and maternal hospital readmission (rehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery), gestational diabetes (insulin and non-insulin dependent), gestational hypertension (>140/90 after 20 weeks GA), pre-eclampsia HELLP Syndrome, Postpartum infection, admission to NICU, APGAR score <6, cord arterial gas pH <7. Chi square statistics will be used to evaluate statistical differences in binary outcomes among fertile and ART-treated groups while ANOVA tests will be implemented to evaluate differences in continuous outcomes. Multivariable models will be adjusted for potential confounders including maternal age (30, 31-34, 35-37, 38-40, >40), smoking (yes/no), chronic hypertension (yes/no), pre-pregnancy diabetes (type 1 and type 2), pre-pregnancy BMI equal to or greater than 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women in BC conceiving by ART | Women in BC with in-province deliveries following pregnancies conceived by assisted reproductive technology occurring between March 1 2008 and April 31 2018 that resulted in singleton live birth or fetal death at >20 weeks. |
| |
| Women in BC conceiving spontaneously | Women in BC with in-province deliveries following pregnancies conceived spontaneously occurring between March 1 2008 and April 31 2018 that resulted in singleton live birth or fetal death at >20 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted Reproductive Technology | Procedure | Assisted Reproductive Technology for the purposes of this study include IVF and IVF+ICSI. Ovulation induction methods are not considered Assisted Reproductive Technology |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy complications beyond 20 weeks gestation age | From point at which patient is 20 weeks gestational age to one month postpartum | |
| Pre-eclampsia | Blood pressure of 140/90 mmHg or higher and symptoms or signs of ongoing damage to internal organs | From point at which patient is 20 weeks gestational age to one month postpartum |
| Gestational hypertension | Blood pressure of 140/90 mmHg or higher and no symptoms or signs of ongoing damage to internal organs | From point at which patient is 20 weeks gestational age to one month postpartum |
| HELPP syndrome | Evidence of hemolysis, elevated liver enzymes, Low platelets | From point at which patient is 20 weeks gestational age to one month postpartum |
| Low birth weight of infant | <2500 grams | From point at which patient is 20 weeks gestational age to one month postpartum |
| small for gestational age | A weight below the 10th percentile for the gestational age. | From point at which patient is 20 weeks gestational age to one month postpartum |
| Gestational diabetes | This outcome is measured from point at which patient is 20 weeks gestational age to one month postpartum | |
| Low APGAR score |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal re-admission to hospital | rehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery | From delivery to 60 days after maternal delivery |
| Maternal postpartum infection |
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Inclusion Criteria:
Exclusion Criteria:
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Women in BC with in-province deliveries (following naturally conceived or assisted reproductive technologies) occurring between March 1 2008 and April 31 2018 that resulted in singleton live birth or fetal death at >20 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Bedaiwy, MD, PhD | University of British Columbia | Principal Investigator |
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AGPAR score less than 6 at time of live birth delivery |
| From point at which patient is 20 weeks gestational age to one month postpartum, depends on delivery timing |
| Cord arterial pH< 7 | At time of delivery of neonate | From point at which patient is 20 weeks gestational age to one month postpartum |
| NICU admission | Admission to NICU | From point at which patient is 20 weeks gestational age to one month postpartum |
| perinatal death | fetal death >20 weeks to death of newborn up to 7 days post-delivery | From point at which patient is 20 weeks gestational age to 7 days post-delivery |
infection from pregnancy and/or delivery
| from delivery to one month postpartum |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D066087 | Perinatal Death |
| D016640 | Diabetes, Gestational |
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D017359 | HELLP Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| ID | Term |
|---|---|
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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