Loading…
Trial eligibility change
| eligibility_criteria | 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. | → | 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 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, terminations, stillbirth and any livebirth (linked or unlinked to a delivery). Exclusion Criteria: * Women with opioids dispensed in the 90 days prior to LMP or during the first trimester (to exclude potential opioid-induced constipation). * Women with inflammatory bowel diseases (IBDs) identified based on ICD codes recorded in the 90 days prior to LMP or during the first trimester (because it is a contraindication). * 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. |
Not scored.No materiality record exists yet for this event.
No other named entities identified.This event has no scored competitor read-through.
No real valuation-relevant phase transition on a resolved asset for this event.This section fires only when the event carries a resolved asset and a real phase change — not guessed for every event.