Skip to content

Trends in Pregnancy Outcomes Beyond Twenty Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in British Columbia

Trends in Pregnancy Outcomes Beyond 20 Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in BC

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06726603
Enrollment
1000
Registered
2024-12-10
Start date
2008-04-30
Completion date
2018-03-31
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Infection

Keywords

Low Birthweight (<2500g), Maternal hospital readmission, Admission to NICU, APGAR Score <6, Cord arterial gas pH<7, premature Birth, Small for gestational Age at Delivery, Perinatal death, Emergency department visit, Gestational Diabetes, Gestational Hypertension, Pre-Eclampsia, HELLP Syndrome, Postpartum infection

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.

Interventions

PROCEDUREAssisted 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

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
perinatal deathFrom point at which patient is 20 weeks gestational age to 7 days post-deliveryfetal death \>20 weeks to death of newborn up to 7 days post-delivery
Cord arterial pH< 7From point at which patient is 20 weeks gestational age to one month postpartumAt time of delivery of neonate
NICU admissionFrom point at which patient is 20 weeks gestational age to one month postpartumAdmission to NICU
Pregnancy complications beyond 20 weeks gestation ageFrom point at which patient is 20 weeks gestational age to one month postpartum
Pre-eclampsiaFrom point at which patient is 20 weeks gestational age to one month postpartumBlood pressure of 140/90 mmHg or higher and symptoms or signs of ongoing damage to internal organs
Gestational hypertensionFrom point at which patient is 20 weeks gestational age to one month postpartumBlood pressure of 140/90 mmHg or higher and no symptoms or signs of ongoing damage to internal organs
HELPP syndromeFrom point at which patient is 20 weeks gestational age to one month postpartumEvidence of hemolysis, elevated liver enzymes, Low platelets
Low birth weight of infantFrom point at which patient is 20 weeks gestational age to one month postpartum\<2500 grams
small for gestational ageFrom point at which patient is 20 weeks gestational age to one month postpartumA weight below the 10th percentile for the gestational age.
Gestational diabetesThis outcome is measured from point at which patient is 20 weeks gestational age to one month postpartum
Low APGAR scoreFrom point at which patient is 20 weeks gestational age to one month postpartum, depends on delivery timingAGPAR score less than 6 at time of live birth delivery

Secondary

MeasureTime frameDescription
Maternal postpartum infectionfrom delivery to one month postpartuminfection from pregnancy and/or delivery
Maternal re-admission to hospitalFrom delivery to 60 days after maternal deliveryrehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026