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

N/AActive Not RecruitingNCT04961840

Takeda100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Constipation Pregnancy

Interventions

No InterventionOTHER

This is a non-interventional study.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: From delivery up to 90 days post-delivery

Secondary Outcomes

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.

Time frame: 90 days prior to the Last menstrual period (LMP) until end of pregnancy

Percentage of Participants With Terminations (Discontinuation of Pregnancy)

Percentage of participants with discontinuation of pregnancy through medication or surgical procedures will be reported.

Time frame: 90 days prior to the LMP until end of pregnancy

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.

Time frame: 90 days prior to the LMP until end of pregnancy

Percentage of Participants With Preterm Delivery

Preterm delivery is defined as a live birth occurring at less than (\<) 37 gestational weeks.

Time frame: From Delivery to 30 days post-delivery

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.

Time frame: From Delivery to 30 days post-delivery

Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission

Percentage of infants admitted to NICU in relation to early and late pregnancy. exposure to prucalopride will be reported.

Time frame: From Delivery to 30 days post-delivery

Percentage of Infants With Hospitalizations

Percentage of infants With Hospitalizations during the first year of life in relation to prenatal exposure to prucalopride will be reported.

Time frame: From Delivery to 365 days post-delivery

Percentage of Infants With Poor Growth and Developmental Delays or Disorders

Percentage of infants With Poor Growth and developmental delays or disorders during the first year of life in relation to prenatal exposure to prucalopride will be reported.

Time frame: From Delivery to 365 days post-delivery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes