Pregnancy ComplicationsNCT01653392
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
An observational study of Pregnancy Complications and Pregnancy Outcome, run by Emergent BioSolutions at 1 site in United States.
Trial summary
The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Pregnancy Outcome, Congenital Abnormalities
- What is being tested?
- Observational Intervention
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Feb 2020
- 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: Active duty female service members who received one or more doses of BioThrax® while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period (LMP) All live born infants born to women who join the registry.
Who may be able to join
- Female active duty service member
- Received one or more dose of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period.
Who cannot join
- Non-service member, non-active duty pregnant female.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Health Research Center
San Diego, California, 92106
About this study
The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
Read the detailed description
This study will use a convenience sample and passive referral to enroll participants.
For the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey).
Outcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.
- Being tested
- Observational Intervention
- Keywords
- Maternal Mortality, Obstetric Labor, Premature, Eclampsia, Pre-Eclampsia, Abortion, Spontaneous, Diabetes, Gestational, Pregnancy, Ectopic, Hydatidiform Mole, Fetal death, Live birth, Still birth, Premature Birth, Sex ratio, Birth weight
- Medical subject headings
- Pregnancy Complications, Congenital Abnormalities, Maternal Death, Obstetric Labor, Premature, Eclampsia, Pre-Eclampsia, Abortion, Spontaneous, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational InterventionBiological
This is an observational study, therefore no interventions are specified.
| Study group | Role | What they receive |
|---|---|---|
| Anthrax Vaccine Adsorbed | Active duty women who received one or more doses of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period, and all live born infants born to women who join the registry. Receives: Biological: Observational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Outcomes
Pregnancy outcomes measured include live birth, still birth, spontaneous abortion, elective termination, ectopic pregnancy, or molar pregnancy Note: Twin or higher order multiple pregnancies may have more than one outcome.
Measured: Up to 44 weeks
Maternal Outcomes
Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Measured: Up to 44 weeks
Infant Outcomes
Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
Measured: Up to 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Naval Health Research Center
- Responsible party
- Sponsor
- Investigators
- Natalie Wells, MD, Principal investigator, Naval Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653392
- Sponsor's protocol ID
- EBS.AVA.010 / NHRC.2012.0003
- Status last verified
- Mar 2024
- First submitted
- 16 Jul 2012
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioThrax® (Anthrax) Vaccine in Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01653392
- Acronym / sponsor ID
- EBS.AVA.010 / NHRC.2012.0003
- Keywords
- Maternal Mortality, Obstetric Labor, Premature, Eclampsia, Pre-Eclampsia, Abortion, Spontaneous, Diabetes, Gestational, Pregnancy, Ectopic, Hydatidiform Mole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Naval Health Research Center
- Study start
- Jul 2012 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 31 Jul 2012 (estimated)
- 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 purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
Detailed description
This study will use a convenience sample and passive referral to enroll participants.
For the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey).
Outcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anthrax Vaccine Adsorbed | – | Biological: Observational InterventionActive duty women who received one or more doses of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period, and all live born infants born to women who join the registry. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Active duty female service members who received one or more doses of BioThrax® while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period (LMP) All live born infants born to women who join the registry.
Key inclusion criteria (2 listed)
- Female active duty service member
- Received one or more dose of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period.
Key exclusion criteria (1 listed)
- Non-service member, non-active duty pregnant female.
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 |
|---|---|---|
| Observational InterventionThis is an observational study, therefore no interventions are specified. | Biological | Anthrax Vaccine Adsorbed |
Primary outcome
Pregnancy Outcomes
Time frame: Up to 44 weeks
Pregnancy outcomes measured include live birth, still birth, spontaneous abortion, elective termination, ectopic pregnancy, or molar pregnancy Note: Twin or higher order multiple pregnancies may have more than one outcome.
Maternal Outcomes
Time frame: Up to 44 weeks
Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Infant Outcomes
Time frame: Up to 1 year of age
Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
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 15 Mar 2024.
- 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.
Natalie Wells, MD principal investigator
Naval Health Research Center
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 Pregnancy Complications and Pregnancy Outcome, run by Emergent BioSolutions 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 2 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 15 Mar 2024. 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?
Pregnancy Outcomes (time frame: Up to 44 weeks). The study lists 3 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 15 Mar 2024.