Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04869280
Other study ID # TAK-555-5001
Secondary ID EUPAS40231
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2021
Est. completion date May 31, 2026

Study information

Verified date June 2023
Source Takeda
Contact Contact
Phone +1-877-311-8972
Email mothertobaby@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. The study is non-interventional. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 616
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) Cohort: - Pregnant women. - Exposure to MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for the treatment of chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (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. - Agree to the conditions and requirements of the study including the interview schedule, and release of medical records. Exclusion Criteria: Cohort 1: Prucalopride-Exposed (MOTEGRITY, RESOTRAN) 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 (brand name or generic) anytime during the current pregnancy; may or may not have taken another medication for their disease in 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention
This is a non-interventional study.

Locations

Country Name City State
United States University of California San Diego La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
Takeda The Organization of Teratology Information Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Major Structural Defects Major structural defects are defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study. Up to 1 year of age
Secondary Number of Participants With Spontaneous Abortion/Miscarriage Spontaneous abortion/miscarriage is defined as non-deliberate fetal death that occurs prior to 20 weeks post-LMP. 20 weeks post-last menstrual period (LMP)
Secondary Number of Participants With Stillbirth Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP. From 20 weeks post-LMP to end of pregnancy
Secondary Number of Participants With Elective Termination/Abortion Elective termination/abortion is defined as deliberate termination of pregnancy through medication or surgical procedures. Elective abortions are classified for medical or social reasons. At the end of pregnancy or through 9-month pregnancy period
Secondary Number of Participants With Premature Delivery Premature delivery is defined as live birth prior to 37 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if LMP uncertain or more than 1 week discrepant). Elective caesarian deliveries or inductions prior to 37 completed weeks will be considered separately. Through 9-month pregnancy period
Secondary Incidence of Small for Gestational Age Small for gestational age is defined as birth size (weight, length or head circumference) less than the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants. At birth
Secondary Number of Participants With Postnatal Growth Deficiency Postnatal growth deficiency is defined as postnatal size (weight, length or head circumference) less than the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age. Up to 1 year of age
Secondary Screening for Neurodevelopmental Milestones Screening for neurodevelopment performed using the Ages and Stages Questionnaire (ASQ). An abnormal score is defined in the scoring guidelines. 1 year of age
Secondary Incidence of Hospitalization in Live Born Children Hospitalizations is defined as any hospitalization of the infant within the first year of life after discharge following delivery. Up to 1 year of age
See also
  Status Clinical Trial Phase
Completed NCT05980988 - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation N/A
Recruiting NCT03819062 - Sacral Neuromodulation as Treatment for Chronic Constipation N/A
Completed NCT00765882 - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation Phase 3
Completed NCT00730171 - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT00354575 - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units Phase 2
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT00765999 - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT01793753 - Effect of Propofol on Internal Anal Sphincter Pressure During ARM N/A
Completed NCT00746200 - Acupuncture for Chronic Constipation Phase 3
Enrolling by invitation NCT00671684 - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease Phase 1/Phase 2
Completed NCT00391820 - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial) Phase 2
Completed NCT00404040 - Movicol in Childhood Constipation (ProMotion Study) Phase 2
Completed NCT02281630 - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC) Phase 2
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Recruiting NCT05192317 - Administration of a Natural Molecular Complex in Functional Chronic Constipation N/A
Active, not recruiting NCT05202028 - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy N/A
Completed NCT05734859 - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation N/A
Completed NCT01007123 - Study of A3309 in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT00402337 - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation Phase 2
Completed NCT02961556 - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation Phase 3