ConstipationNCT04961840
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
An observational study of Constipation and Pregnancy, run by Takeda at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Constipation, Pregnancy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 30 Jun 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will include pregnancy women with constipation including those with constipation predominant irritable bowel syndrome.
Who may be able to join
- Pregnant women aged 18 to 44 years with constipation.
- Maternal coverage by health care and prescriptions insurance during eligibility period:
- 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 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, terminations, stillbirth and any livebirth (linked or unlinked to a delivery).
Who cannot join
- Women with opioids dispensed in the 90 days prior to LMP or during the first trimester (to exclude potential opioid-induced constipation).
- Women with inflammatory bowel diseases (IBDs) identified based on ICD codes recorded in the 90 days prior to LMP or during the first trimester (because it is a contraindication).
- 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 locations and contacts
1 site in 1 country.
United States1 site
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy
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:
Read more
- 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.
- Conditions
- Constipation, Pregnancy
- Being tested
- No Intervention
- Keywords
- Prucalopride, infant outcomes
- Medical subject headings
- Constipation
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 | Pregnant women with clinically diagnosis of constipation who have been exposed to prucalopride during pregnancy will be observed. Receives: Other: No Intervention | |
| Cohort 2: Pregnant Women Not Exposed to Prucalopride | Pregnant women with clinical diagnosis of constipation who have been exposed to other constipation drugs and not prucalopride during pregnancy will be observed. Receives: Other: No Intervention | |
| Cohort 3: Untreated Pregnant Women | Pregnant women with clinical diagnosis of constipation with no recorded prescription dispensed for any constipation drugs during pregnancy 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 Infants With Major Congenital Malformations
A major congenital malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Major malformations will be sorted and grouped according to the International Classification of Diseases 10th Revision (ICD-10). Percentage of infants with major congenital malformations after birth will be reported.
Measured: From delivery up to 90 days post-delivery
Secondary outcomes (8)
Percentage of Participants With Spontaneous Abortions
Spontaneous abortions will be defined as spontaneous losses before 20 weeks of gestation. Percentage of participants with spontaneous abortion will be reported.
Measured: 90 days prior to the Last menstrual period (LMP) until end of pregnancy
Percentage of Participants With Terminations (Discontinuation of Pregnancy)
Percentage of participants with discontinuation of pregnancy through medication or surgical procedures will be reported.
Measured: 90 days prior to the LMP until end of pregnancy
Percentage of Participants With Stillbirths
Stillbirths will be defined as in utero fetal deaths at or after 20 weeks of gestation. Percentage of participants with stillbirths will be reported.
Measured: 90 days prior to the LMP until end of pregnancy
Percentage of Participants With Preterm Delivery
Preterm delivery is defined as a live birth occurring at less than (<) 37 gestational weeks.
Measured: From Delivery to 30 days post-delivery
Percentage of Infants With Small for Gestational Age (SGA)
SGA will be defined as weight at birth of full and preterm live-born infants in <10th percentile. Percentage of infants with SGA will be reported.
Measured: From Delivery to 30 days post-delivery
Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission
Percentage of infants admitted to NICU in relation to early and late pregnancy. exposure to prucalopride will be reported.
Measured: From Delivery to 30 days post-delivery
Percentage of Infants With Hospitalizations
Percentage of infants With Hospitalizations during the first year of life in relation to prenatal exposure to prucalopride will be reported.
Measured: From Delivery to 365 days post-delivery
Percentage of Infants With Poor Growth and Developmental Delays or Disorders
Percentage of infants With Poor Growth and developmental delays or disorders during the first year of life in relation to prenatal exposure to prucalopride will be reported.
Measured: From Delivery to 365 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961840
- Sponsor's protocol ID
- TAK-555-5002
- Other IDs
- EUPAS41866
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2021
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride During Pregnancy
- ClinicalTrials.gov ID
- NCT04961840
- Acronym / sponsor ID
- TAK-555-5002
- Conditions
- Constipation, Pregnancy
- Keywords
- Prucalopride, infant outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jul 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Pregnant Women Exposed to Prucalopride | – | Other: No InterventionPregnant women with clinically diagnosis of constipation who have been exposed to prucalopride during pregnancy will be observed. |
| Cohort 2: Pregnant Women Not Exposed to Prucalopride | – | Other: No InterventionPregnant women with clinical diagnosis of constipation who have been exposed to other constipation drugs and not prucalopride during pregnancy will be observed. |
| Cohort 3: Untreated Pregnant Women | – | Other: No InterventionPregnant women with clinical diagnosis of constipation with no recorded prescription dispensed for any constipation drugs during pregnancy will be observed. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include pregnancy women with constipation including those with constipation predominant irritable bowel syndrome.
Key inclusion criteria (6 listed)
- Pregnant women aged 18 to 44 years with constipation.
- Maternal coverage by health care and prescriptions insurance during eligibility period:
- 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, terminations, stillbirth and any livebirth (linked or unlinked to a delivery).
Key exclusion criteria (3 listed)
- Women with opioids dispensed in the 90 days prior to LMP or during the first trimester (to exclude potential opioid-induced constipation).
- Women with inflammatory bowel diseases (IBDs) identified based on ICD codes recorded in the 90 days prior to LMP or during the first trimester (because it is a contraindication).
- 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.
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, Cohort 2: Pregnant Women Not Exposed to Prucalopride, Cohort 3: Untreated Pregnant Women |
Primary outcome
Percentage of Infants With Major Congenital Malformations
Time frame: From delivery up to 90 days post-delivery
A major congenital malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Major malformations will be sorted and grouped according to the International Classification of Diseases 10th Revision (ICD-10). Percentage of infants with major congenital malformations after birth will be reported.
8 secondary outcomes
Percentage of Participants With Spontaneous Abortions
Time frame: 90 days prior to the Last menstrual period (LMP) until end of pregnancy
Percentage of Participants With Terminations (Discontinuation of Pregnancy)
Time frame: 90 days prior to the LMP until end of pregnancy
Percentage of Participants With Stillbirths
Time frame: 90 days prior to the LMP until end of pregnancy
Percentage of Participants With Preterm Delivery
Time frame: From Delivery to 30 days post-delivery
Percentage of Infants With Small for Gestational Age (SGA)
Time frame: From Delivery to 30 days post-delivery
Percentage of Infants With Neonatal Intensive Care Unit (NICU) Admission
Time frame: From Delivery to 30 days post-delivery
Percentage of Infants With Hospitalizations
Time frame: From Delivery to 365 days post-delivery
Percentage of Infants With Poor Growth and Developmental Delays or Disorders
Time frame: From Delivery to 365 days post-delivery
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 13 Oct 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.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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
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 Constipation and Pregnancy, 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 6 inclusion and 3 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 13 Oct 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 Infants With Major Congenital Malformations (time frame: From delivery up to 90 days post-delivery). 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 13 Oct 2026.