Clinical Trials Logo

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - >/= 2 live births - Livebirths occurring 2000-2020 Exclusion Criteria: - Incomplete records - Women with multiple gestations (at 1st or 2nd births) - Stillbirths

Study Design


Intervention

Other:
Recurrent pregnancy loss
As described before.

Locations

Country Name City State
Canada BC Women's Hospital & Health Centre Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Children's & Women's Health Centre of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time between first birth and second birth Time interval in Weeks Time between first birth and second birth during 2000-2020
Secondary Live birth rate Proportion of patients achieving second live birth 10 years after first live birth
Secondary Obstetrical outcomes Gestational age at birth, antepartum hemorrhage, pregnancy-induced hypertension, intrauterine growth restriction, diabetes in pregnancy, mode of delivery, birth weight, maternal need for transfusion at delivery, sex of infant, APGAR at 5 and 10 minutes Live births during 2000-2020
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Completed NCT06338254 - Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women N/A
Recruiting NCT04825093 - Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19 N/A
Completed NCT04739462 - SMS Maama Project COVID-19 N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06357962 - Semi-permanent Acupuncture Effect on Cervical Ripening N/A
Not yet recruiting NCT06430853 - Psychobiological Interventions in Pregnancy N/A
Not yet recruiting NCT03661749 - Urinary Protein to Creatinine Ratio in Term Pregnant Women N/A
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Completed NCT02191774 - Medical Abortion up to 10 Weeks Gestation at Home
Completed NCT01322529 - Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be N/A
Completed NCT00678080 - Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes N/A
Completed NCT00746551 - Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment Phase 4
Completed NCT00634530 - Impact of a Nutritional Intervention Program for Weight Control During Pregnancy N/A
Completed NCT00197561 - Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection Phase 3
Completed NCT05527327 - Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study N/A
Recruiting NCT05551078 - Thrombophilia Screening After Severe IUGR
Recruiting NCT03100084 - PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome