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NCT Number: NCT06726603

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

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.

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Key information

Conditions

Postpartum Infection Cardiovascular Diseases Death Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders HELLP Syndrome Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pre-Eclampsia Pregnancy Complications Premature Birth Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pregnancy complications beyond 20 weeks gestation age

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

  2. Pre-eclampsia

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    Blood pressure of 140/90 mmHg or higher and symptoms or signs of ongoing damage to internal organs

  3. Gestational hypertension

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    Blood pressure of 140/90 mmHg or higher and no symptoms or signs of ongoing damage to internal organs

  4. HELPP syndrome

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    Evidence of hemolysis, elevated liver enzymes, Low platelets

  5. Low birth weight of infant

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    <2500 grams

  6. small for gestational age

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    A weight below the 10th percentile for the gestational age.

  7. Gestational diabetes

    Time frame: This outcome is measured from point at which patient is 20 weeks gestational age to one month postpartum

  8. Low APGAR score

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum, depends on delivery timing

    AGPAR score less than 6 at time of live birth delivery

  9. Cord arterial pH< 7

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    At time of delivery of neonate

  10. NICU admission

    Time frame: From point at which patient is 20 weeks gestational age to one month postpartum

    Admission to NICU

  11. perinatal death

    Time frame: From point at which patient is 20 weeks gestational age to 7 days post-delivery

    fetal death >20 weeks to death of newborn up to 7 days post-delivery

Secondary outcomes

  1. Maternal re-admission to hospital

    Time frame: From delivery to 60 days after maternal delivery

    rehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery

  2. Maternal postpartum infection

    Time frame: from delivery to one month postpartum

    infection from pregnancy and/or delivery

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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