Skip to main content
OpenTrials
Completed

NCT Number: NCT01653392

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Complications Abortion, Spontaneous Birth Weight Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Diabetes Mellitus Diabetes, Gestational Eclampsia Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Death Gestational Trophoblastic Disease Glucose Metabolism Disorders Hydatidiform Mole Hypertension, Pregnancy-Induced Maternal Death Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications, Neoplastic Pregnancy Outcome Pregnancy, Ectopic Premature Birth Signs and Symptoms Stillbirth Trophoblastic Neoplasms Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Naval Health Research Center

San Diego, California, 92106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Non-service member, non-active duty pregnant female.

Treatment and study plan

Observational Intervention

Biological

This is an observational study, therefore no interventions are specified.

Primary outcomes

  1. 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.

  2. Maternal Outcomes

    Time frame: Up to 44 weeks

    Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.

  3. Infant Outcomes

    Time frame: Up to 1 year of age

    Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • Naval Health Research Center

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2012
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.