Skip to main content
OpenTrials
Completed

NCT Number: NCT06369272

Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

The primary objectives of this study are:

In infants of women exposed to SPIKEVAX during pregnancy, to assess:

* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs). * If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19). * In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders [e.g., pre-eclampsia, eclampsia, and gestational hypertension] gestational diabetes, and post-partum hemorrhage; and * To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maternal Outcomes Infant Outcomes Pregnancy

Age range

13 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Carelon Research

Newton, Massachusetts, 02458, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • EOP within study period
  • Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.

Exclusion criteria

  • Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis.
  • Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.

Treatment and study plan

Primary outcomes

  1. Number of MCMs

    Time frame: Up to approximately 3 years

  2. Number of Adverse Neonatal and Infant Outcomes

    Time frame: Up to approximately 3 years

    Adverse neonatal and infant outcomes include neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, or incidence of hospitalization due to infections including COVID-19.

  3. Number of Participants with Hypertensive Disorders

    Time frame: Up to approximately 3 years

    Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage

  4. Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Demographics: Participant Region of Residence

    Time frame: Baseline

  2. Demographics: Age at LMP

    Time frame: Baseline

  3. Demographics: Number of Overweight or Obese Participants

    Time frame: Baseline

  4. Demographics: Duration of Health Plan Enrolment Prior to Pregnancy

    Time frame: Baseline

  5. Demographics: Calendar Date of the Pregnancy Outcome

    Time frame: Baseline

  6. Demographics: Participant Race and Ethnicity

    Time frame: Baseline

  7. Demographics: Participant Socio-economic Status

    Time frame: Baseline

  8. Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations

    Time frame: Baseline

  9. Healthcare Utilization: Number of Distinct Medications Used

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2024
Registry last updated
Apr 16, 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.