Chronic Idiopathic Constipation (CIC)NCT04869280
Post-Marketing Study of Prucalopride Safety In Pregnancy
An observational study of Chronic Idiopathic Constipation (CIC), run by Takeda at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chronic Idiopathic Constipation (CIC)
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women from the United States (US) and Canada who have or have not been treated with prucalopride for CIC or IBS-C during their pregnancy.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy
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.
Read more
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.
- Conditions
- Chronic Idiopathic Constipation (CIC)
- Being tested
- No Intervention
- Keywords
- Fetal and infant outcomes, Prucalopride, Pregnancy Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort-1: Pregnant Women Exposed to Prucalopride Prior to Enrollment | Pregnant women diagnosed with chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (IBS-C) who have been exposed to prucalopride during pregnancy and prior to enrollment will be observed. Receives: Other: No Intervention | |
| Cohort-2: Pregnant Women Not Exposed to Prucalopride | Pregnant women diagnosed with CIC or IBS-C who have not been exposed to prucalopride will be observed. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year of age
Secondary outcomes (8)
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.
Measured: 20 weeks post-last menstrual period (LMP)
Number of Participants With Stillbirth
Stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP.
Measured: From 20 weeks post-LMP to end of pregnancy
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.
Measured: At the end of pregnancy or through 9-month pregnancy period
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.
Measured: Through 9-month pregnancy period
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.
Measured: At birth
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.
Measured: Up to 1 year of age
Screening for Neurodevelopmental Milestones
Screening for neurodevelopment performed using the Ages and Stages Questionnaire (ASQ). An abnormal score is defined in the scoring guidelines.
Measured: 1 year of age
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.
Measured: Up to 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start21 May 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Constipation (CIC)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, TakedaStudy Director, Study director, The Organization of Teratology Information Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869280
- Sponsor's protocol ID
- TAK-555-5001
- Other IDs
- EUPAS40231
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prucalopride (MOTEGRITY®, RESOTRAN®) Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study of Prucalopride Safety in Pregnancy
- ClinicalTrials.gov ID
- NCT04869280
- Acronym / sponsor ID
- TAK-555-5001
- Conditions
- Chronic Idiopathic Constipation (CIC)
- Keywords
- Fetal and infant outcomes, Prucalopride, Pregnancy Registry
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Study start
- 21 May 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort-1: Pregnant Women Exposed to Prucalopride Prior to Enrollment | – | Other: No InterventionPregnant women diagnosed with chronic idiopathic constipation (CIC) or irritable bowel syndrome-constipation (IBS-C) who have been exposed to prucalopride during pregnancy and prior to enrollment will be observed. |
| Cohort-2: Pregnant Women Not Exposed to Prucalopride | – | Other: No InterventionPregnant women diagnosed with CIC or IBS-C who have not been exposed to prucalopride will be observed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women from the United States (US) and Canada who have or have not been treated with prucalopride for CIC or IBS-C during their pregnancy.
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Cohort-1: Pregnant Women Exposed to Prucalopride Prior to Enrollment, Cohort-2: Pregnant Women Not Exposed to Prucalopride |
Primary outcome
Percentage of Participants With Major Structural Defects
Time frame: Up to 1 year of age
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.
8 secondary outcomes
Number of Participants With Spontaneous Abortion/Miscarriage
Time frame: 20 weeks post-last menstrual period (LMP)
Number of Participants With Stillbirth
Time frame: From 20 weeks post-LMP to end of pregnancy
Number of Participants With Elective Termination/Abortion
Time frame: At the end of pregnancy or through 9-month pregnancy period
Number of Participants With Premature Delivery
Time frame: Through 9-month pregnancy period
Incidence of Small for Gestational Age
Time frame: At birth
Number of Participants With Postnatal Growth Deficiency
Time frame: Up to 1 year of age
Screening for Neurodevelopmental Milestones
Time frame: 1 year of age
Incidence of Hospitalization in Live Born Children
Time frame: Up to 1 year of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Study Director study director
The Organization of Teratology Information Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Idiopathic Constipation (CIC), run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Major Structural Defects (time frame: Up to 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.