Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Rate of major congenital malformations
研究概览
简要总结
Orilissa is a drug approved for the management of moderate to severe pain associated with endometriosis. Oriahnn is approved for heavy menstrual bleeding due to uterine fibroids. Elagolix-containing products should not be taken by women who are pregnant or suspected to be pregnant but pregnancies are expected as the medicine does not completely stop ovulation and women may inadvertently continue taking Elagolix-containing products until their pregnancy is confirmed.
This study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with and without exposure to Elagolix-containing products for their endometriosis or other conditions based on approved indications and prescribing patterns of Elagolix. Around 584 participants will be enrolled (292 participants exposed to Elagolix and 292 without exposure) in the United States.
Participants will not receive Elagolix-containing products as part of this study but will be followed for maternal and fetal outcomes up to 1 year after delivery.
There may be a higher burden for participants in this study compared to standard of care. Participants will be asked to provide additional information by questionnaire during each trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. Contact Bloom Pregnancy Call Center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit https://www.bloompregnancyregistry.com/.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants exposed to Elagolix:
- •Currently pregnant.
- •Documentation that the participant was exposed to elagolix-containing product from 14 days after last menstrual period (LMP) or at any time during pregnancy.
- •Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.
- •Internal Comparator:
- •Currently pregnant with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of elagolix-containing product.
- •Documentation that the participant was not exposed to elagolix-containing product from 14 days after LMP or any time during pregnancy.
- •Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.
排除标准
- 未提供
结局指标
主要结局
Rate of major congenital malformations
时间窗: Approximately 2 years (1 year post-delivery)
Defined as an abnormality in structural development that is medically or cosmetically significant, present at birth, and persists in postnatal life unless or until repaired.
次要结局
- Rate of elective or therapeutic pregnancy termination(Up to 9 months)
- Rate of preterm birth(Up to 9 months)
- Rate of maternal placental issues(Up to 9 months)
- Rate of minor congenital malformations(Approximately 2 years (1 year post-delivery))
- Rate of spontaneous abortion(Up to 9 months)
- Rate of stillbirth(Up to 9 months)
- Rate of small for gestation age infants(Up to 9 months)
- Rate of postnatal growth deficiency or failure to thrive(Approximately 2 years (1 year post-delivery))