Clinical trial NCT06726603: Trends in Pregnancy Outcomes Beyond Twenty Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in British Columbia
Official title: Trends in Pregnancy Outcomes Beyond 20 Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in BC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Infection
Keywords: Low Birthweight (&lt;2500g)
Maternal hospital readmission
Admission to NICU
APGAR Score &lt;6
Cord arterial gas pH&lt;7
premature Birth
Small for gestational Age at Delivery
Perinatal death
Emergency department visit
Gestational Diabetes
Gestational Hypertension
Pre-Eclampsia
HELLP Syndrome
Postpartum infection
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Examining outcomes beyond 20 weeks gestational age in pregnancies conceived by ART compared to spontaneously conceived pregnancies

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: 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.

Eligibility criteria: Inclusion Criteria:

* 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 and women conceiving their index pregnancy by assisted reproductive technology (ART) will be included.

Exclusion Criteria:

* Multiparous women and women with multiple gestation deliveries will be excluded
* any women missing data including gravida, parity, age, date of birth, neonatal birth weight, neonatal APGARs, neonatal live birth versus stillbirth will be excluded

Primary outcomes:
measure: Pregnancy complications beyond 20 weeks gestation age
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: Pre-eclampsia
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: Gestational hypertension
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: HELPP syndrome
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: Low birth weight of infant
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: small for gestational age
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: Gestational diabetes
timeFrame: This outcome is measured from point at which patient is 20 weeks gestational age to one month postpartum
measure: Low APGAR score
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum, depends on delivery timing
measure: Cord arterial pH< 7
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: NICU admission
timeFrame: From point at which patient is 20 weeks gestational age to one month postpartum
measure: perinatal death
timeFrame: From point at which patient is 20 weeks gestational age to 7 days post-delivery
Secondary outcomes:
measure: Maternal re-admission to hospital
timeFrame: From delivery to 60 days after maternal delivery
measure: Maternal postpartum infection
timeFrame: from delivery to one month postpartum
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Mohamed Bedaiwy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: