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

NCT06726603 | Completed

• 1 other identifier: H20-00461-A
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

1. 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. 2.To examine the trend of outcomes beyond 20 weeks GA associated with ART by calendar year from March 2008 to April 2018.

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

Outcome Measures

Primary Outcomes (11)

• 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

  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

Secondary Outcomes (2)

• Maternal re-admission to hospital

  From delivery to 60 days after maternal delivery

• Maternal postpartum infection

  from delivery to one month postpartum

Study Arms (2)

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.

Procedure: 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.

Interventions

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

Women in BC conceiving by ART

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Premature Birth; Perinatal Death; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pre-Eclampsia; HELLP Syndrome

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Mohamed Bedaiwy, MD, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: December 10, 2024
• Study Start: April 1, 2008
• Primary Completion: March 1, 2018
• Study Completion: March 31, 2018
• Last Updated: December 10, 2024

Record last verified: 2021-02