Pregnancy Complications, Pregnancy, High Risk, Pregnancy Related
Conditions
Keywords
Relugolix, Uterine Fibroids, Endometriosis, Pregnancy
Brief summary
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.
Detailed description
The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.
Interventions
DRUGRelugolix + Estradiol + Norethindrone Acetate
Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)
Sponsors
Sumitomo Pharma Switzerland GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Woman ≥ 18 and ≤ 50 years of age at time of conception * Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception) Cohort 1 * Exposure to relugolix combination therapy at any time during pregnancy Cohort 2 * No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)
Exclusion criteria
* Exposure to known teratogens during pregnancy * \< 6 months of continuous healthcare coverage immediately prior to date of conception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Congenital Malformation (MCM) | Up to 5 years | Comparison of rate of MCM between cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Small for gestational age (SGA) | Up to 5 years | Comparison of rate of SGA between cohorts |
| Spontaneous abortion (SAB) | Up to 5 years | Comparison of rate of SABs between cohorts |
| Stillbirth | Up to 5 years | Comparison of rate of stillbirths between cohorts |
| Preterm birth | Up to 5 years | Comparison of rate of preterm births between cohorts |
Countries
United States
Outcome results
None listed