Clinical trial NCT04961840: A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
Official title: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Constipation
Pregnancy
Keywords: Fetal and infant outcomes
Prucalopride
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include privately insured pregnant women from the Unite States with a clinical diagnosis of constipation.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Infants With Major Congenital Malformations
timeFrame: Last menstrual period (LMP) up to 90 days after delivery
Secondary outcomes:
measure: Percentage of Participants With Spontaneous Abortions
timeFrame: LMP up to 20 weeks of gestation
measure: Percentage of Participants With Stillbirths
timeFrame: After 20 weeks of gestation up to end of pregnancy
measure: Percentage of Participants With Preterm Delivery
timeFrame: LMP up to 37 weeks of gestation
measure: Percentage of Infants With Small for Gestational Age (SGA)
timeFrame: Up to 30 days after delivery
measure: Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission
timeFrame: Up to 30 days after delivery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H. Chan School of Public Health
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: