Summary

Eligibility
for females (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Christina Chambers, PhD, MPH
Photo of Christina Chambers
Christina Chambers

Description

Summary

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. Participation begins after a pregnant woman has taken prucalopride. 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.

Official Title

Prucalopride Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance of Prucalopride Safety in Pregnancy

Keywords

Chronic Constipation Fetal and infant outcomes Prucalopride Pregnancy Registry Constipation

Eligibility

You can join if…

Open to females

Cohort 1: Prucalopride-Exposed Cohort:

  • Pregnant women.
  • Exposure to prucalopride for the treatment of CIC or IBS-C, for any number of days, at any dose, and at any time from the 1st day of the LMP up to and including the 12th week after the first day of the LMP. If the date of LMP is unclear, or if a first-trimester ultrasound has been done and the estimated date of conception is more than one week discrepant from the menstrual period calculation, the first-trimester ultrasound-derived date will be used to calculate a date for LMP and conception.
  • Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.

Cohort 2: Disease-Matched Comparison Cohort:

  • Pregnant women.
  • Diagnosed with CIC or IBS-C; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible.
  • No exposure to prucalopride at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy.
  • Agree to the conditions and requirements of the study including the interview schedule, and release of medical records.

You CAN'T join if...

Cohort 1: Prucalopride-Exposed Cohort

  • Women who have first contact with the project after prenatal diagnosis of any major structural defect.
  • Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
  • Women who have used prucalopride for an indication other than CIC or IBS-C.
  • Women who do not have exposure in the first trimester of pregnancy.
  • Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
  • Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.

Cohort 2: Disease-Matched Comparison Cohort:

  • Women who have first contact with the project after prenatal diagnosis of any major structural defect.
  • Exposure to prucalopride anytime during the current pregnancy.
  • Women who have enrolled in the prucalopride cohort study with a previous pregnancy (women may only enroll once in the Prucalopride Pregnancy Cohort Study).
  • Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment).
  • Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.

Location

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Christina Chambers, PhD, MPH
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Vice Chair of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital. She is a perinatal epidemiologist, whose research is focused on environmental exposures and pregnancy and child health outcomes, including birth defects.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
To obtain more information on the study, click here/on this link
ID
NCT04869280
Study Type
Observational
Last Updated