Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in 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
- 125
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Major Structural Defects
研究概览
简要总结
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy.
Participants are not required to take prucalopride during the study. The study is non-interventional. Women and their infants are followed during pregnancy and for 1 year after pregnancy to collect information on maternal, pregnancy, and infant outcomes.
During the study, participants will be asked questions during 3 telephone interviews; 2 during pregnancy and 1 just after their expected delivery date. Participants who took or are taking prucalopride will be asked more detailed questions about this during these interviews. All information is collected remotely, and no visits to the study site are required.
Also, all participants will be asked to complete a questionnaire about their baby when their baby is about 1 year old.
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
- •Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) Cohort:
- •Pregnant women.
- •Exposure to MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for the treatment of chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (IBS-C), for any number of days, at any dose, and at any time from the 1st day of the LMP up to and including the 12th week after the first day of the LMP. If the date of LMP is unclear, or if a first-trimester ultrasound has been done and the estimated date of conception is more than one week discrepant from the menstrual period calculation, the first-trimester ultrasound-derived date will be used to calculate a date for LMP and conception.
- •Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.
- •Cohort 2: Disease-Matched Comparison Cohort:
- •Pregnant women.
- •Diagnosed with CIC or IBS-C; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible.
- •Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.
排除标准
- •Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) Cohort
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect.
- •Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
- •Women who have used prucalopride for an indication other than CIC or IBS-C.
- •Women who do not have exposure in the first trimester of pregnancy.
- •Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
- •Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- •Cohort 2: Disease-Matched Comparison Cohort:
- •Women who have first contact with the project after prenatal diagnosis of any major structural defect.
- •Exposure to prucalopride (brand name or generic) anytime during the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy.
- •Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
- •Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
- •Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
结局指标
主要结局
Percentage of Participants With Major Structural Defects
时间窗: Up to 1 year of age
Major structural defects are defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.
次要结局
- Number of Participants With Elective Termination/Abortion(At the end of pregnancy or through 9-month pregnancy period)
- Number of Participants With Spontaneous Abortion/Miscarriage(20 weeks post-last menstrual period (LMP))
- Incidence of Small for Gestational Age(At birth)
- Number of Participants With Postnatal Growth Deficiency(Up to 1 year of age)
- Number of Participants With Stillbirth(From 20 weeks post-LMP to end of pregnancy)
- Number of Participants With Premature Delivery(Through 9-month pregnancy period)
- Incidence of Hospitalization in Live Born Children(Up to 1 year of age)
- Screening for Neurodevelopmental Milestones(1 year of age)