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

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).