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

Takeda

Status: Active, not recruiting

Conditions: Constipation; Pregnancy

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04961840

EUPAS41866 (Other Identifier)

TAK-555-5002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Cohort 1: Pregnant Women Exposed to Prucalopride

Description:

Pregnant women with clinically diagnosis of constipation who have been exposed to prucalopride during pregnancy will be observed.

Treatment:

Other: No Intervention

Cohort 2: Pregnant Women Not Exposed to Prucalopride

Description:

Pregnant women with clinical diagnosis of constipation who have been exposed to other constipation drugs and not prucalopride during pregnancy will be observed.

Treatment:

Other: No Intervention

Cohort 3: Untreated Pregnant Women

Description:

Pregnant women with clinical diagnosis of constipation with no recorded prescription dispensed for any constipation drugs during pregnancy will be observed.

Treatment:

Other: No Intervention