RPL: Interval to Live Birth and Adverse Perinatal Outcomes

May 25, 2023 updated by: Dr. Mohamed Bedaiwy, Children's & Women's Health Centre of British Columbia

Does a History of Recurrent Pregnancy Loss Predict a Prolonged Interval to the Second Live Birth or Increased Adverse Perinatal Outcomes for Women in British Columbia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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 </= 35 at age of first birth and first delivery recorded between the year 2000-2010. The investigators will assume that this cohort will be more likely to try for a second pregnancy rather than an older group. Furthermore, there will be 10 to 20 years of follow-up data from the year 2010. A Kaplan-meier curve will be constructed showing the cumulative live birth rate for patients with RPL, primary RPL, secondary RPL, and control group, controlling for age, BMI, city of residence, use of IVF, number of miscarriages, consecutive RPL, and school years completed.

Lastly, the medical and obstetric characteristics of the pregnancies resulting in live birth after the diagnosis of RPL will be analyzed between the 4 groups (primary RPL, secondary RPL, all RPL, control). The associations between the previous diagnosis of RPL and adverse perinatal outcomes will be determined using logistic regression analyses.

Study Type

Observational

Enrollment (Estimated)

140000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital & Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Those included in a provincially inclusive database that aggregates obstetrics and neonatal variables from all attended births in British Columbia from 2000-2018

Description

Inclusion Criteria:

  • >/= 2 live births
  • Livebirths occurring 2000-2020

Exclusion Criteria:

  • Incomplete records
  • Women with multiple gestations (at 1st or 2nd births)
  • Stillbirths

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recurrent pregnancy loss
All women with >/=2 pregnancy loss before 20 weeks gestational age
Other: Recurrent pregnancy loss
As described before.
Primary recurrent pregnancy loss
Primary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age before the first birth
Other: Recurrent pregnancy loss
As described before.
Secondary recurrent pregnancy loss
Secondary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age occurring after the first birth
Other: Recurrent pregnancy loss
As described before.
No history of recurrent pregnancy loss
Those with 0 or 1 previous spontaneous pregnancy loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time between first birth and second birth
Time Frame: Time between first birth and second birth during 2000-2020
Time interval in Weeks
Time between first birth and second birth during 2000-2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 10 years after first live birth
Proportion of patients achieving second live birth
10 years after first live birth
Obstetrical outcomes
Time Frame: Live births during 2000-2020
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's & Women's Health Centre of British Columbia

Investigators

  • Principal Investigator: Mohamed A. Bedaiwy, FACOG, FRCSC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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