Postpartum InfectionNCT06726603
Trends in Pregnancy Outcomes Beyond Twenty Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in British Columbia
An observational study of Postpartum Infection, run by University of British Columbia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Infection
- What is being tested?
- Assisted Reproductive Technology
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to 31 Mar 2018
- How long will I take part?
- 1 Year
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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
- 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.
- To examine the trend of outcomes beyond 20 weeks GA associated with ART by calendar year from March 2008 to April 2018.
Read more
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.
Read the 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.
- Conditions
- Postpartum Infection
- Being tested
- Assisted Reproductive Technology
- Keywords
- 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, Perinatal death, Emergency department visit, Gestational Diabetes, Gestational Hypertension, Pre-Eclampsia, HELLP Syndrome, Postpartum infection
- Medical subject headings
- Premature Birth, Perinatal Death, Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Reproductive TechnologyProcedure or surgery
Assisted Reproductive Technology for the purposes of this study include IVF and IVF+ICSI. Ovulation induction methods are not considered Assisted Reproductive Technology
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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 being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy complications beyond 20 weeks gestation age
Measured: 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
Measured: 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
Measured: From point at which patient is 20 weeks gestational age to one month postpartum
HELPP syndrome
Evidence of hemolysis, elevated liver enzymes, Low platelets
Measured: From point at which patient is 20 weeks gestational age to one month postpartum
Low birth weight of infant
<2500 grams
Measured: 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.
Measured: From point at which patient is 20 weeks gestational age to one month postpartum
Gestational diabetes
Measured: 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
Measured: 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
Measured: From point at which patient is 20 weeks gestational age to one month postpartum
NICU admission
Admission to NICU
Measured: 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
Measured: From point at which patient is 20 weeks gestational age to 7 days post-delivery
Secondary outcomes (2)
Maternal re-admission to hospital
rehospitalization 0-60 days after delivery plus emergency department of observation stay visits 0-7 days after delivery
Measured: From delivery to 60 days after maternal delivery
Maternal postpartum infection
infection from pregnancy and/or delivery
Measured: from delivery to one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study startApr 2008
- Primary completionMar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bedaiwy, University of British Columbia
- Investigators
- Mohamed Bedaiwy, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726603
- Sponsor's protocol ID
- H20-00461-A
- Status last verified
- Feb 2021
- First submitted
- 29 Apr 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in Pregnancy Outcomes Beyond 20 Weeks Gestational Age in Assisted Reproductive Technology Conceived Pregnancies in BC
- ClinicalTrials.gov ID
- NCT06726603
- Acronym / sponsor ID
- H20-00461-A
- Conditions
- Postpartum Infection
- Keywords
- 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, Perinatal death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 10 Dec 2024 (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.
Examining outcomes beyond 20 weeks gestational age in pregnancies conceived by ART compared to spontaneously conceived pregnancies
- 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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women in BC conceiving by ART | – | Procedure: Assisted Reproductive TechnologyWomen 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Assisted Reproductive TechnologyAssisted Reproductive Technology for the purposes of this study include IVF and IVF+ICSI. Ovulation induction methods are not considered Assisted Reproductive Technology | Procedure or surgery | Women in BC conceiving by ART |
Primary outcome
Pregnancy complications beyond 20 weeks gestation age
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
Pre-eclampsia
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
Blood pressure of 140/90 mmHg or higher and symptoms or signs of ongoing damage to internal organs
Gestational hypertension
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
Blood pressure of 140/90 mmHg or higher and no symptoms or signs of ongoing damage to internal organs
HELPP syndrome
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
Evidence of hemolysis, elevated liver enzymes, Low platelets
Low birth weight of infant
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
<2500 grams
small for gestational age
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
A weight below the 10th percentile for the gestational age.
Gestational diabetes
Time frame: This outcome is measured from point at which patient is 20 weeks gestational age to one month postpartum
Low APGAR score
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum, depends on delivery timing
AGPAR score less than 6 at time of live birth delivery
Cord arterial pH< 7
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
At time of delivery of neonate
NICU admission
Time frame: From point at which patient is 20 weeks gestational age to one month postpartum
Admission to NICU
perinatal death
Time frame: From point at which patient is 20 weeks gestational age to 7 days post-delivery
fetal death >20 weeks to death of newborn up to 7 days post-delivery
2 secondary outcomes
Maternal re-admission to hospital
Time frame: From delivery to 60 days after maternal delivery
Maternal postpartum infection
Time frame: from delivery to one month postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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 Bedaiwy, MD, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Infection, run by University of British Columbia.
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 2 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy complications beyond 20 weeks gestation age (time frame: From point at which patient is 20 weeks gestational age to one month postpartum). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.