Pregnancy and Lactation Studies
ENROLLING PREGNANCY AND LACTATION STUDIES
Albireo BYLVAY Pregnancy and Lactation Surveillance Program Information
- Toll-free phone number (US Only): 1-877-390-2762
- Fax number (US Only): 1-877-390-3661
- Email address: [email protected]
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:
- Toll-free phone number (U.S.): +1 833 377 7633 (Option 5)
- Email address: [email protected]
BMS Camzyos Pregnancy Surveillance Program
- Toll-free phone number (US Only): +1-877-390-2852
- Fax number (US Only): +1-877 495-0810
- Email address: [email protected]
CIBINQO™ Pregnancy Registry
- Toll-free phone number (North America): +1 877 311 3770
- Toll-free worldwide access fax number: +1 877 311 3781
- Email address: [email protected]
- Website: www.cibinqopregnancyregistry.com
GLOW PREGNANCY REGISTRY
If you have been exposed to SKYRIZI®(risankizumab-rzaa) or related medication during pregnancy or within 5 months (20 weeks) prior to becoming pregnant, you may be eligible to participate in this U.S. registry. Pregnant women and their healthcare providers may contact the registry at:
- Toll-free phone number (North America): +1 877 302 2161
- Toll-free worldwide access fax number: +1 877 896 0927
- Email address: [email protected]
- Website: https://glowpregnancyregistry.com
- Clinicaltrials.gov: www.clinicaltrials.gov/ct2/show/NCT04846959?cond=Skyrizi&draw=2&rank=8
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:
- Toll-free phone number (U.S.): +1 844 443 7734
- Toll-free fax number (U.S.): +1 877 202 3940
- Email address: [email protected]
- Website: www.heplisavbpregnancyregistry.com
MyRose Pregnancy Registry
- Toll-free phone number (North America): +1 877 390 2723
- Toll-free worldwide access fax number: +1 877 390 2711
- Email address: [email protected]
- Website: www.relugolixCTpregnancyregistry.com
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:
- Toll-free phone number (U.S.): +1 877 366 0324
- Email address: [email protected]
- Website: www.nurtecpregnancyregistry.com
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:
- Toll-free phone number (North America): +1 877 283 6220
- Toll-free worldwide access fax number: +1 877 284 3341
- Email address: [email protected]
- Website: https://sunosipregnancyregistry.com
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:
- Toll-free phone number (U.S.): +1 855 850 2138
- Toll-free fax number (U.S.): +1 855 850 2137
- Website: www.tevagenerics.com/acitretin
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:
- Toll-free phone number (U.S.): + 1 877 302 2813
- Toll-free fax number (U.S.): + 1 877 777 5622
- Email address: [email protected]
- Website: www.wakixpregnancyregistry.com
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:
- Toll-free phone number (North America): +1 877 390 2760
- Toll-free worldwide access fax number: +1 877 390 3126
- Email address: [email protected]
- Website: https://wegovypregnancyregistry.com
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:
- Toll-free phone number (North America): +1 877 301 9314
- Toll-free worldwide access fax number: +1 877 777 6337
- Email address: [email protected]
- Website: www.zeposiapregnancyregistry.com/
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 postmarketing 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 postmarketing 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: [email protected]
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 postmarketing 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:
[email protected]