BioThrax® (Anthrax) Vaccine in Pregnancy Registry

NCT01653392 | Completed

• 1 other identifier: EBS.AVA.010 / NHRC.2012.0003
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications; Pregnancy Outcome; Congenital Abnormalities

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 44 weeks

• Maternal Outcomes

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

  Up to 44 weeks

• Infant Outcomes

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

  Up to 1 year of age

Study Arms (1)

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.

Biological: Observational Intervention

Interventions

Observational Intervention BIOLOGICAL

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

Anthrax Vaccine Adsorbed

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Naval Health Research Center: collaborator

Study Sites (1)

Naval Health Research Center

San Diego, California, 92106, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Congenital Abnormalities; Maternal Death; Obstetric Labor, Premature; Eclampsia; Pre-Eclampsia; Abortion, Spontaneous; Diabetes, Gestational; Pregnancy, Ectopic; Hydatidiform Mole; Fetal Death; Stillbirth; Premature Birth; Birth Weight

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Gestational Trophoblastic Disease; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Body Weight; Signs and Symptoms

Study Officials

• Natalie Wells, MD

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)