Pregnancy and Lactation Studies

Our Solutions Clinical Development Peri and Post-Approval Non-Interventional Studies Pregnancy and Lactation Studies

Enrolling pregnancy and lactation studies

Albireo Bylvay Pregnancy and Lactation Surveillance Program Information

Bempedoic Acid Pregnancy Surveillance Program

If you are pregnant and have taken Nexletol® (bempedoic acid) or Nexlizet® (bempedoic acid/ezetimibe) at any time during pregnancy, you are eligible to participate in this study. The pregnant woman or one of her health care providers may contact the registry at:

BMS Camzyos Pregnancy Surveillance Program

BRIUMVI Pregnancy Registry

Are you pregnant and diagnosed with multiple sclerosis? Have you taken BRIUMVI (ublituximab-xiiy) or other multiple sclerosis medications during your pregnancy? You may be eligible to participate in this U.S. registry. Pregnant women and their health care providers may contact the registry at:

CIBINQO™ Pregnancy Registry

GLOW Pregnancy Registry

If you have been exposed to SKYRIZI®(risankizumab-rzaa) or related medications during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception), you may be eligible to participate in this U.S. registry.

Eligible Diagnoses: Plaque psoriasis, psoriatic arthritis, and Crohn’s disease & ulcerative colitis
Eligible Exposures: Risankizumab or other medications in the same class or line of therapy as risankizumab (e.g., tumor necrosis factor [TNF] inhibitors, interleukin [IL]-17 inhibitors, IL-12/23 inhibitors, other IL-23 inhibitors) during pregnancy.

Pregnant women and their healthcare providers may contact the registry at:

HEPLISAV-B® (Hepatitis B Vaccine [Recombinant], Adjuvanted) Pregnancy Registry

Pregnant women who have been vaccinated with HEPLISAV-B® (Hepatitis B Vaccine [Recombinant], Adjuvanted) within 28 days prior to conception or at any time during the pregnancy are eligible to participate in this U.S. registry. They may contact the registry at:

MyRose Pregnancy Registry

The Migraine Observational Nurtec Pregnancy Registry (MONITOR)

If you are a pregnant person diagnosed with migraine and have taken Nurtec®  ODT (rimegepant) or other migraine medications during pregnancy you may qualify to participate. Pregnant people (residing in the US) and their healthcare providers may contact the registry at:

The Penbraya™ Pregnancy Registry

RSV Vaccine Pregnancy Registry (RSV-PR)

The study team is looking for people aged 18 to 50 who are pregnant and either plan to receive the recommended vaccine in the third trimester, recently received the recommended respiratory syncytial virus (RSV) vaccine at or after week 32 of pregnancy or have chosen to not receive the RSV vaccine. Pregnant individuals and their healthcare providers may contact the registry at:

SUNOSI Pregnancy Registry

You may be eligible if you are:

  • Taking or have taken SUNOSI®(solriamfetol) or other wake-promoting medications or stimulants for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA)
  • OR a pregnant woman diagnosed with narcolepsy or OSA
  • OR a pregnant woman who not does have a diagnosis of narcolepsy or OSA, but who has taken at least one dose of SUNOSI or another wake-promoting medication or stimulant during pregnancy (sine the first day of your last menstrual period)

Pregnant women and their healthcare providers may contact the registry at:

T.A.P.P. (Take Action to Prevent Pregnancy) Pregnancy Monitoring Program for Acitretin

If you think you’ve become pregnant while taking Acitretin or within three years of stopping, contact the program at:

WAKIX® (pitolisant) Pregnancy Registry

If you have become pregnant while taking WAKIX® (pitolisant) or if you have taken WAKIX® at any time during your pregnancy, you are encouraged to enroll in this registry. The pregnant woman or one of her health care providers may contact the registry at:

WEGOVY Pregnancy Registry

You may be eligible if you are:

  • A resident of the United States, United Kingdom, or Spain; and
  • 15-50 years old; and
  • A pregnant woman who has been diagnosed with either:
    • Obesity, or
    • Overweight with at least one weight-related comorbidity (e.g. high blood pressure, diabetes, or high cholesterol)

You may be eligible to participate whether or not you’ve taken weight loss medications like Wegovy® (semaglutide 2.4 mg) during pregnancy.

Pregnant women and their healthcare providers may contact the registry at:

Zeposia MS Pregnancy Registry

If you are pregnant and have been diagnosed with multiple sclerosis and or exposed to ZEPOSIA® (ozanimod) or other multiple sclerosis medications during pregnancy or within 3 months prior to pregnancy, you might be eligible to participate in this U.S. and Canada registry. The pregnant woman or one of her health care providers may contact the registry at:

Closed pregnancy and lactation studies

Belimumab (benlysta™) Pregnancy Registry

A global observational study of the use of belimumab (BENLYSTA™) in pregnant women and their offspring.

Belimumab (BENLYSTA®) Pregnancy Registry – Full Text View – ClinicalTrials.gov

BEXSERO® Pregnancy Registry

An observational study of the use and safety of BEXSERO® in pregnant women and their offspring.
www.clinicaltrials.gov/ct2/show/NCT02640677?term=Bexsero+Pregnancy+Registry&rank=1

CRADLE

A multicenter post-marketing study to evaluate breast milk transfer in lactating mothers receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
www.clinicaltrials.gov/ct2/show/NCT02154425?term=CRADLE&rank=3

CRIB

A multicenter post-marketing study to evaluate placental transfer in women receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
www.clinicaltrials.gov/ct2/show/NCT02019602?term=CRIB&rank=4

MENVEO® Vaccine Pregnancy Registry

An observational study of the use and safety of MENVEO® in pregnant women and their offspring.
www.clinicaltrials.gov/ct2/show/NCT02223637?term=Menveo+pregnancy+registry&rank=1

Oseltamivir Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of oseltamivir exposure in pregnant women and their offspring.
Email address: pregnancyand.infantregistriessm@ppdi.com

The CHERISH Study

A multicenter postmarketing study to measure certolizumab pegol (Cimzia®) plasma levels in the blood over the course of pregnancy and after delivery.
www.clinicaltrials.gov/ct2/show/NCT04163016?term=UP0085&draw=2&rank=1

Vedolizumab (Entyvio®) Lactation Study

A multicenter post-marketing study to evaluate breast milk transfer in women receiving vedolizumab (Entyvio®) for ulcerative colitis or Crohn’s disease.
www.clinicaltrials.gov/ct2/show/NCT02559713?term=Vedolizumab+%28Entyvio%C2%AE%29+Lactation+Study&rank=1

Xolair® Pregnancy Registry

An observational study of the use and safety of Xolair® (Omalizumab) during pregnancy (EXPECT).
www.clinicaltrials.gov/ct2/show/NCT00373061?term=EXPECT&rank=10

Zanamivir (Relenza inhalation powder) Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of zanamivir (Relenza inhalation powder) exposure in pregnant women and their offspring.

Email address:
pregnancyand.infantregistriessm@ppdi.com