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.
Study Type
OBSERVATIONAL
Enrollment
127
This is a non-interventional study.
University of California San Diego
La Jolla, California, United States
Percentage of Participants With Major Structural Defects
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.
Time frame: Up to 1 year of age
Number of Participants With Spontaneous Abortion/Miscarriage
Spontaneous abortion/miscarriage is defined as non-deliberate fetal death that occurs prior to 20 weeks post-LMP.
Time frame: 20 weeks post-last menstrual period (LMP)
Number of Participants With Stillbirth
Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP.
Time frame: From 20 weeks post-LMP to end of pregnancy
Number of Participants With Elective Termination/Abortion
Elective termination/abortion is defined as deliberate termination of pregnancy through medication or surgical procedures. Elective abortions are classified for medical or social reasons.
Time frame: At the end of pregnancy or through 9-month pregnancy period
Number of Participants With Premature Delivery
Premature delivery is defined as live birth prior to 37 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if LMP uncertain or more than 1 week discrepant). Elective caesarian deliveries or inductions prior to 37 completed weeks will be considered separately.
Time frame: Through 9-month pregnancy period
Incidence of Small for Gestational Age
Small for gestational age is defined as birth size (weight, length or head circumference) less than the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants.
Time frame: At birth
Number of Participants With Postnatal Growth Deficiency
Postnatal growth deficiency is defined as postnatal size (weight, length or head circumference) less than the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.
Time frame: Up to 1 year of age
Screening for Neurodevelopmental Milestones
Screening for neurodevelopment performed using the Ages and Stages Questionnaire (ASQ). An abnormal score is defined in the scoring guidelines.
Time frame: 1 year of age
Incidence of Hospitalization in Live Born Children
Hospitalizations is defined as any hospitalization of the infant within the first year of life after discharge following delivery.
Time frame: Up to 1 year of age
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