Exposure During PregnancyNCT05803200
A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy
An observational study of Exposure During Pregnancy, run by Takeda at 1 site in United States.
Trial summary
The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Exposure During Pregnancy
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 14 Apr 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 16 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end of pregnancy and their infants included in the MarketScan Research Database during the period 2014-2020.
Who may be able to join
None listed.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data
The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.
Read the detailed description
This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.
This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort:
- HyQvia
This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US.
The overall time for data collection in this study will be approximately 7 years.
- Conditions
- Exposure During Pregnancy
- Being tested
- No intervention
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
No intervention was given as this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| HyQvia | Pregnant female participants who have insurance coverage with full prescriptions benefits exposed to HyQvia during the period from 90 days before the last menstrual period (LMP) through 30 days after delivery will be observed retrospectively from 1 January 2014 to 31 December 2020 (up to 7 years). Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Congenital Malformations in the Infant
A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Data for infants will be reviewed in the database from the date of delivery to 90 days following birth to check for any malformations. The number of infants with malformations during the database period of 1 January 2014 to 31 December 2020 (up to 7 years) will be reported.
Measured: Up to 7 years
Number of Participants with Spontaneous Abortion
Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.
Measured: Up to 7 years
Number of Participants with Stillbirth
Stillbirth is defined as a fetal death after 20 weeks of gestation.
Measured: Up to 7 years
Number of Participants with Preterm Birth
Pre-term birth is defined as delivery before 37 weeks of gestation.
Measured: Up to 7 years
Number of Participants Being Small for Gestational Age (SGA)
SGA will be defined as weight at birth of full and preterm live-born infants in <10th percentile.
Measured: Up to 7 years
Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)
NICU admissions will be identified by current procedure terminology (CPT) codes in maternal and infant claims within 30 days of delivery.
Measured: Up to 7 years
Number of Participants With Any Major Clinical Diagnosis or Procedures
Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Mar 2023
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure During PregnancyStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803200
- Sponsor's protocol ID
- TAK-771-4004
- Other IDs
- EUPAS103800
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data
- ClinicalTrials.gov ID
- NCT05803200
- Acronym / sponsor ID
- TAK-771-4004
- Conditions
- Exposure During Pregnancy
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 7 Apr 2023 (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.
The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.
Detailed description
This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.
This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort:
- HyQvia
This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US.
The overall time for data collection in this study will be approximately 7 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HyQvia | – | Drug: No interventionPregnant female participants who have insurance coverage with full prescriptions benefits exposed to HyQvia during the period from 90 days before the last menstrual period (LMP) through 30 days after delivery will be observed retrospectively from 1 January 2014 to 31 December 2020 (up to 7 years). |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end of pregnancy and their infants included in the MarketScan Research Database during the period 2014-2020.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| No interventionNo intervention was given as this is an observational study. | Drug | HyQvia |
Primary outcome
Number of Participants with Major Congenital Malformations in the Infant
Time frame: Up to 7 years
A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Data for infants will be reviewed in the database from the date of delivery to 90 days following birth to check for any malformations. The number of infants with malformations during the database period of 1 January 2014 to 31 December 2020 (up to 7 years) will be reported.
Number of Participants with Spontaneous Abortion
Time frame: Up to 7 years
Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.
Number of Participants with Stillbirth
Time frame: Up to 7 years
Stillbirth is defined as a fetal death after 20 weeks of gestation.
Number of Participants with Preterm Birth
Time frame: Up to 7 years
Pre-term birth is defined as delivery before 37 weeks of gestation.
Number of Participants Being Small for Gestational Age (SGA)
Time frame: Up to 7 years
SGA will be defined as weight at birth of full and preterm live-born infants in <10th percentile.
Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Up to 7 years
NICU admissions will be identified by current procedure terminology (CPT) codes in maternal and infant claims within 30 days of delivery.
Number of Participants With Any Major Clinical Diagnosis or Procedures
Time frame: Up to 7 years
Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.
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 25 Sep 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
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 Exposure During Pregnancy, run by Takeda at 1 site in United States.
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 0 inclusion and 1 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 25 Sep 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 United States. 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?
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?
Number of Participants with Major Congenital Malformations in the Infant (time frame: Up to 7 years). The study lists 7 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 25 Sep 2023.