Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of Infants With Major Congenital Malformations
研究概览
简要总结
This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records.
It will include the following groups:
- Those who took prucalopride.
- Those who took other medicines for constipation.
- Those who did not take any prescription medicines for constipation.
The main aim of the study is to find out whether the medicine prucalopride, which is used to treat constipation, is safe for use during pregnancy and to look at whether taking prucalopride at certain times during pregnancy is associated to a higher chance of specific health problems for the mother or baby.
The study uses two large existing healthcare insurance databases for collecting information. Participants are not enrolled, treated, or required to visit the doctor during this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18 to 44 years with constipation.
- •Maternal coverage by health care and prescriptions insurance during eligibility period:
- •a) To study pregnancy outcomes (live births, spontaneous abortions, terminations, or stillbirths): 90 days prior to the LMP until end of pregnancy; and b) to study malformations, perinatal and infant outcomes: 90 days to LMP until 30 days post-delivery.
- •For infant outcomes, the cohort will be restricted to pregnancies with linked offspring.
- •For major malformations, only pregnancies with livebirths will be included, since information regarding the pathological results from a pregnancy loss or the indication for termination is rarely recorded. In addition, infants are required to have full insurance coverage from delivery to at least 90 days after the delivery, unless the infant died prior to the end of the 90 days, in which case a shorter eligibility period until death is permitted.
- •For the analyses of pregnancy losses, the cohort also includes pregnancies ending in spontaneous abortion, terminations, stillbirth and any livebirth (linked or unlinked to a delivery).
排除标准
- •Women with opioids dispensed in the 3 months prior to LMP or during the first trimester (to exclude potential opioid-induced constipation) and women with inflammatory bowel diseases (IBD) (because IBD is a contraindication)
- •For major malformations, the cohort excludes pregnancies with a chromosomal abnormality based on at least one inpatient or outpatient ICD-9 code for 758.xx,759.81-759.83, or 655.1x within 90 days after delivery in the infant and/or maternal claims.
- •For major malformations, pregnancies with outpatient exposure to definite teratogens including warfarin, valproate, antineoplastic agents, colchicine, testosterone, radioiodine, isotretinoin, misoprostol, and thalidomide from LMP through LMP plus 90 days.
结局指标
主要结局
Percentage of Infants With Major Congenital Malformations
时间窗: From delivery up to 90 days post-delivery
A major congenital malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Major malformations will be sorted and grouped according to the International Classification of Diseases 10th Revision (ICD-10). Percentage of infants with major congenital malformations after birth will be reported.
次要结局
- Percentage of Participants With Spontaneous Abortions(90 days prior to the Last menstrual period (LMP) until end of pregnancy)
- Percentage of Participants With Terminations (Discontinuation of Pregnancy)(90 days prior to the LMP until end of pregnancy)
- Percentage of Participants With Stillbirths(90 days prior to the LMP until end of pregnancy)
- Percentage of Participants With Preterm Delivery(From Delivery to 30 days post-delivery)
- Percentage of Infants With Small for Gestational Age (SGA)(From Delivery to 30 days post-delivery)
- Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission(From Delivery to 30 days post-delivery)
- Percentage of Infants With Hospitalizations(From Delivery to 365 days post-delivery)
- Percentage of Infants With Poor Growth and Developmental Delays or Disorders(From Delivery to 365 days post-delivery)