Evaluating Prucalopride (Motegrity®) Use in Pregnancy & Lactation

Better safety info starts with your referral.

MotherToBaby Pregnancy Studies and the Mommy’s Milk: Human Milk Research Biorepository are looking for pregnant and/or lactating patients in the U.S. who have been diagnosed with Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C) to take part in our research studies.

Why are we conducting these studies? Prescription medications may come to market with little to no information on the safety of the product when used in human pregnancy and lactation. This leaves health providers in a bind when treating patients of reproductive potential. We’re actively working to fill these information gaps with our observational pregnancy and lactation studies, and we need your help to do it.

Participants self-enroll in our studies, so after you make the referral nothing further is required from you. Both studies are strictly observational; your patient will not be asked to change any aspect of their current healthcare routine, including their medications. 

The MotherToBaby Pregnancy Study

Who can participate in the MotherToBaby research study?
MotherToBaby is enrolling pregnant persons, or those planning to become pregnant, diagnosed with CIC or IBS-C who reside in the U.S. This is a cohort study, so both those who have and those who have not used prucalopride in a current or recent pregnancy may be eligible.

What does the MotherToBaby study involve?
Participants self-enroll and can expect:

  • 1-3 telephone interviews during pregnancy + at least 1 post-partum interview
  • Releasing medical records for their pregnancy and baby up to one year of age
  • Developmental follow-up of the baby up to one year of age

The Mommy’s Milk Lactation Study

Who can participate in the Mommy’s Milk study?
Mommy’s Milk is enrolling lactating persons age 18+ years who reside in the U.S. and who are using prucalopride while breastfeeding a child who is ≤ 11 months of age.

What does the Mommy’s Milk study involve?
Participants self-enroll and can expect:

  • Telephone interviews
  • Providing 4-7 milk samples over a 24-hour period before & after taking a regular dose of prucalopride. Milk samples are collected at home using mom’s pump and will be shipped to the study office using materials we provide at no cost to the mom.
  • Releasing baby’s medical records up to 16 months of age

Volunteers will receive up to $125 for completing the study.

How Do I Refer a Patient? 

It’s easy! Get permission from the patient to refer them to us, then simply fill out our Refer Now form. Download our Patient Communication Toolkit for suggestions on how to talk to your patients about our studies and other ways you can refer them to us.

Refer Now!

MotherToBaby Pregnancy Studies and Mommy’s Milk: Human Milk Research Biorepository are research programs housed at the UC San Diego School of Medicine and led by Dr. Christina Chambers, a perinatal epidemiologist whose research has been instrumental in identifying previously unrecognized human teratogens, as well as ruling out substantial risk for other medications and vaccines. The information collected helps inform the medical community and the general public about the safety of medications when used in pregnancy and lactation.

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Questions? Call 866.626.6847 | Text 855.999.3525 | Email or Chat at MotherToBaby.org.

Disclaimer: MotherToBaby Fact Sheets are meant for general information purposes and should not replace the advice of your health care provider. MotherToBaby is a service of the non-profit Organization of Teratology Information Specialists (OTIS). OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm. Copyright by OTIS, July 7, 2021.