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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Infection
• Intervention / Treatment: Procedure: Assisted Reproductive Technology

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal re-admission to hospital	rehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery	From delivery to 60 days after maternal delivery
Maternal postpartum infection	infection from pregnancy and/or delivery	from delivery to one month postpartum

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Mohamed Bedaiwy, MD, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pre-Eclampsia; Gestational Diabetes; Gestational Hypertension; Perinatal death; Postpartum infection; HELLP Syndrome; Emergency department visit; 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
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: H20-00461-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No