Abortion, SpontaneousNCT04360564
RPL: Interval to Live Birth and Adverse Perinatal Outcomes
An observational study of Abortion, Spontaneous and Abortion, Habitual, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Spontaneous, Abortion, Habitual, Birth Intervals
- What is being tested?
- Recurrent pregnancy loss
- How many people
- 140,000 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- >/= 2 live births
- Livebirths occurring 2000-2020
Who cannot join
- Incomplete records
- Women with multiple gestations (at 1st or 2nd births)
- Stillbirths
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Women's Hospital & Health Centre
Vancouver, British Columbia, V6H 3N1
About this study
Official title: 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.
Read the 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.
- Conditions
- Abortion, Spontaneous, Abortion, Habitual, Birth Intervals, Pregnancy Loss, Pregnancy Complications
- Being tested
- Recurrent pregnancy loss
- Keywords
- recurrent pregnancy loss, time to live birth, live birth rate, perinatal outcomes
- Medical subject headings
- Abortion, Spontaneous, Abortion, Habitual, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrent pregnancy lossOther
As described before.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent pregnancy loss | All women with >/=2 pregnancy loss before 20 weeks gestational age Receives: Other: Recurrent pregnancy loss | |
| Primary recurrent pregnancy loss | Primary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age before the first birth Receives: Other: Recurrent pregnancy loss | |
| Secondary recurrent pregnancy loss | Secondary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age occurring after the first birth Receives: Other: Recurrent pregnancy loss | |
| No history of recurrent pregnancy loss | Those with 0 or 1 previous spontaneous pregnancy loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between first birth and second birth
Time interval in Weeks
Measured: Time between first birth and second birth during 2000-2020
Secondary outcomes (2)
Live birth rate
Proportion of patients achieving second live birth
Measured: 10 years after first live birth
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
Measured: Live births during 2000-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 140,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mohamed Bedaiwy, Children's & Women's Health Centre of British Columbia
- Investigators
- Mohamed A. Bedaiwy, FACOG, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360564
- Sponsor's protocol ID
- 1055
- Status last verified
- May 2023
- First submitted
- 15 Apr 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho K, Fayek B, Liu YD, Albert A, Wiesenthal E, Dobrer S, AbdelHafez FF, Lisonkova S, Bedaiwy MA. A history of recurrent pregnancy loss is associated with increased perinatal complications, but not necessarily a longer birth interval: a population study spanning 18 years. Hum Reprod. 2024 May 2;39(5):1105-1116. doi: 10.1093/humrep/deae029.
PubMed 38390658
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04360564
- Acronym / sponsor ID
- 1055
- Conditions
- Abortion, Spontaneous, Abortion, Habitual, Birth Intervals, Pregnancy Loss, Pregnancy Complications
- Keywords
- recurrent pregnancy loss, time to live birth, live birth rate, perinatal outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140,000 participants (estimated)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recurrent pregnancy loss | – | Other: Recurrent pregnancy lossAll women with >/=2 pregnancy loss before 20 weeks gestational age |
| Primary recurrent pregnancy loss | – | Other: Recurrent pregnancy lossPrimary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age before the first birth |
| Secondary recurrent pregnancy loss | – | Other: Recurrent pregnancy lossSecondary RPL is defined by those with >/=2 pregnancy loss before 20 weeks gestational age occurring after the first birth |
| No history of recurrent pregnancy loss | – | –Those with 0 or 1 previous spontaneous pregnancy loss. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- >/= 2 live births
- Livebirths occurring 2000-2020
Key exclusion criteria (3 listed)
- Incomplete records
- Women with multiple gestations (at 1st or 2nd births)
- Stillbirths
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recurrent pregnancy lossAs described before. | Other | Primary recurrent pregnancy loss, Recurrent pregnancy loss, Secondary recurrent pregnancy loss |
Primary outcome
Time between first birth and second birth
Time frame: Time between first birth and second birth during 2000-2020
Time interval in Weeks
2 secondary outcomes
Live birth rate
Time frame: 10 years after first live birth
Obstetrical outcomes
Time frame: Live births during 2000-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Derived from this study: PubMed 38390658Cho K, Fayek B, Liu YD, Albert A, Wiesenthal E, Dobrer S, AbdelHafez FF, Lisonkova S, Bedaiwy MA. A history of recurrent pregnancy loss is associated with increased perinatal complications, but not necessarily a longer birth interval: a population study spanning 18 years. Hum Reprod. 2024 May 2;39(5):1105-1116. doi: 10.1093/humrep/deae029.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A. Bedaiwy, FACOG, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Spontaneous and Abortion, Habitual, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between first birth and second birth (time frame: Time between first birth and second birth during 2000-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.