A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy

Study Overview
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Brief Summary
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This study will collect information on pregnant women diagnosed with constipation from their 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 assess the risk of major birth defects with the mother's use of prucalopride during the first 3 months of pregnancy. The study uses existing health care insurance information; participants are not enrolled, treated, or required to visit the doctor during this study.

Official Title
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Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy

Conditions
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Constipation, Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with constipation. Maternal coverage by health care and prescriptions insurance during eligibility period: Live births: 90 days prior to the last menstrual period until 30 days post-delivery; abortions (spontaneous abortions): from 180 days prior to the first code for abortion to 30 days after this diagnosis; stillbirths: from 180 days prior to the first code for stillbirth to 30 days after this diagnosis. 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 pathology 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, stillbirth and any livebirth (linked or unlinked to a delivery). Exclusion Criteria: Termination of pregnancy will be identified but excluded from analyses (since malformations are rarely coded and these pregnancies will not be at risk for other outcomes). Pregnancies in which prucalopride is dispensed in the 3 months prior to the LMP but not during the first trimester (to ensure that there is not misclassification of the non-exposed) 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 (because they are 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, antineoplastic agents, isotretinoin, misoprostol, and thalidomide from LMP through LMP plus 90 days (that is, days of exposure overlap with 1st trimester).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Pregnant Women Exposed to Prucalopride<br>Pregnant women with clinically diagnosis of constipation who have been exposed to prucalopride during pregnancy will be observed. | |
| Cohort 2: Pregnant Women Not Exposed to Prucalopride<br>Pregnant women with clinical diagnosis of constipation who have been exposed to other laxative and not prucalopride constipation drugs during pregnancy will be observed. | |
| Cohort 3: Untreated Pregnant Women<br>Pregnant women with clinical diagnosis of constipation with no recorded prescription dispensed for any constipation drugs during pregnancy will be observed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Infants With Major Congenital Malformations | 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. | Last menstrual period (LMP) up to 90 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Spontaneous Abortions | Spontaneous abortions will be defined as spontaneous losses before 20 weeks of gestation. Percentage of participants with spontaneous abortion will be reported. | LMP up to 20 weeks of gestation | 
| Percentage of Participants With Stillbirths | Stillbirths will be defined as in utero fetal deaths at or after 20 weeks of gestation. Percentage of participants with stillbirths will be reported. | After 20 weeks of gestation up to end of pregnancy | 
| Percentage of Participants With Preterm Delivery | Preterm delivery is defined as a live birth occurring at less than (<) 37 gestational weeks. | LMP up to 37 weeks of gestation | 
| Percentage of Infants With Small for Gestational Age (SGA) | SGA will be defined as weight at birth of full and preterm live-born infants in <10th percentile. Percentage of infants with SGA will be reported. | Up to 30 days after delivery | 
| Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission | Percentage of infants admitted to NICU will be reported. | Up to 30 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal and infant outcomes, Prucalopride