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Completed

NCT Number: NCT05803200

A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy

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.

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Key information

Conditions

Exposure During Pregnancy

Age range

16 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

• Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.

Exclusion criteria

  • NA

Treatment and study plan

No intervention

Drug

No intervention was given as this is an observational study.

Primary outcomes

  1. 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.

  2. Number of Participants with Spontaneous Abortion

    Time frame: Up to 7 years

    Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.

  3. Number of Participants with Stillbirth

    Time frame: Up to 7 years

    Stillbirth is defined as a fetal death after 20 weeks of gestation.

  4. Number of Participants with Preterm Birth

    Time frame: Up to 7 years

    Pre-term birth is defined as delivery before 37 weeks of gestation.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Sep 25, 2023

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.

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