Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04360564 |
| Other study ID # |
1055 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 13, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Children's & Women's Health Centre of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This will be a retrospective observational cohort study utilizing the data from the British
Columbia Perinatal Data Registry (BCPDR). The BCPDR is a provincially inclusive database that
aggregates obstetrics and neonatal variables from all attended births in British Columbia.
The primary objective of this study is to evaluate and contrast the average time interval
from the first to second birth for patients with recurrent pregnancy loss compared to healthy
controls. Secondarily, the investigators will calculate the cumulative live birth rate in the
cohort of women with recurrent pregnancy loss who were </= 35 at age of first birth and
delivered between the years 2000-2010. Finally, the investigators will compare the incidence
of adverse perinatal outcomes for those with recurrent pregnancy loss and those without.
The results of this study will be valuable for clinicians and patients as it will provide
information for prognosis counselling. This will also help those desiring more than one child
with long term family planning.
Description:
Recurrent pregnancy loss (RPL) is defined as 2 or more pregnancy losses by the European
Society of Human Reproduction and Embryology and affects 2-5% of the population. RPL can be
further classified into primary and secondary pregnancy losses, with secondary RPL diagnosed
when one has achieved a previous live birth. RPL is a frustrating and distressing condition
as nearly 50% of patients have no medical explanation for the cause of pregnancy loss. For
these patients, research regarding the prognosis and time to live birth is essential.
This will be a retrospective observational cohort study utilizing the data from the British
Columbia Perinatal Data Registry (BCPDR). The BCPDR is a provincially inclusive database that
aggregates obstetrics and neonatal variables from all attended births in British Columbia.
Since April 2000, there are up to 700, 000 births included in this database. The study
population will be divided into 4 groups: those without RPL (control group), all patients
with RPL, primary RPL, and secondary RPL. Within the RPL group, primary RPL is defined by
those with >/=2 pregnancy loss before 20 weeks gestational age before the first birth and the
remaining patients will make up the secondary RPL group.
The following demographic variables will be requested: age at first delivery, age at second
delivery, the average number of pregnancy loss before first birth, number of pregnancy loss
before second birth, BMI at first delivery, BMI at second delivery, principle residence, use
of in vitro fertilization to conceive, obstetrical status (number of pregnancies, term
deliveries, preterm deliveries, miscarriages, and living children) at first and second birth,
school years completed, smoking, at-risk alcohol use, preexisting hypertension, preexisting
diabetes, psychiatric illnesses, the number of infant(s) born in first and second delivery,
live birth/stillbirth. Primary outcome variables include the date (year, month, and day) of
delivery for the first and second live births.
For our second objective, the investigators will analyze the cumulative live birth rate of a
subgroup who is
