Trends in Pregnancy Outcomes Beyond Twenty Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in British Columbia
NCT ID: NCT06726603
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2008-04-30
2018-03-31
Brief Summary
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1. To determine if a difference in outcomes for pregnancies beyond 20 weeks gestational age exists between ART-treated and spontaneous conception populations in BC. Specifically, the investigators will examine the prevalence for gestational diabetes, gestational hypertension, premature deliveries, low birth weight, miscarriages, maternal length of stay in hospital, NICU admissions, APGAR scores\<6, and arterial cord gas pH\<7.
2. To examine the trend of outcomes beyond 20 weeks GA associated with ART by calendar year from March 2008 to April 2018.
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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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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.
Assisted Reproductive Technology
Assisted Reproductive Technology for the purposes of this study include IVF and IVF+ICSI. Ovulation induction methods are not considered Assisted Reproductive Technology
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.
No interventions assigned to this group
Interventions
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Assisted Reproductive Technology
Assisted Reproductive Technology for the purposes of this study include IVF and IVF+ICSI. Ovulation induction methods are not considered Assisted Reproductive Technology
Eligibility Criteria
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Inclusion Criteria
* Only fertile and women conceiving their index pregnancy by assisted reproductive technology (ART) will be included.
Exclusion Criteria
* any women missing data including gravida, parity, age, date of birth, neonatal birth weight, neonatal APGARs, neonatal live birth versus stillbirth will be excluded
FEMALE
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Mohamed Bedaiwy
Principle Investigator
Principal Investigators
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Mohamed Bedaiwy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Other Identifiers
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H20-00461-A
Identifier Type: -
Identifier Source: org_study_id