Clinical Trials

HER Foundation has supported hyperemesis gravidarum (HG) research, education, and advocacy for 25 years. This comprehensive guide helps you understand your rights, evaluate opportunities, and access support throughout any clinical trial journey. We believe informed patients make the best decisions for their families.

A trial sponsored by NGM Bio is open in the Philippines, Australia, and the UK.
For research related to HG, see our Research Opportunities page.
The HER Foundation is here to support anyone in a HG clinical trial as well as those who do not qualify. We have support groups, peer support, and education on alternative treatment options.

Read more about the EMERALD clinical trial open for a limited time for those currently suffering from HG. This trial is open to patients residing in the UK, Australia, and the Philippines.

Can I participate in the EMERALD trial by NGM Bio if I live in the US?

What is the HER Foundation's role in the EMERALD trial?

Thinking about participating in a clinical trial?

Here are ideas on what to think about if you would like to be part of a clinical trial. Some information may be limited by the specific trial protocol.

Should I participate in a clinical trial?

Only you can make the decision with your medical team if a clinical trial is appropriate for you. There are questions you may want to ask of the clinical research team to help with your decision:

What are the requirements for me to participate in this study?
Has this therapeutic been studied in non-pregnant women?
What will I receive and how often?
What are my responsibilities if I participate?
What HG care will you provide and what will my OBGYN provide?
Can I continue my current HG treatments while in the study?
What happens if HG gets worse during the study?
How long will my baby and I be monitored?
What obstetric care will I receive during the study?
What happens if I need transportation or other costs to participate?
Who pays for any medical care related to the study?
Will I receive study results when available?
What happens if I move or change doctors during the study?
Are there any costs I might be responsible for?
What if I need to withdraw from the study early?

Costs Typically Covered by a Study

Experimental medication or treatment
Study-related medical tests and procedures
Additional monitoring and assessments
Research team consultations
Travel reimbursement

What are my rights and protections?

In the USA, the FDA regulates clinical drug trials. Regardless of where a clinical trial takes place, you have fundamental rights as a research participant. These rights are protected by international standards and local regulations:

Informed Consent: You must receive detailed information about risks, benefits, and alternatives in language you understand
Right to Withdraw: You can leave the study at any time without penalty or loss of medical care
Independent Ethics Review: Ethics committees must review and monitor all aspects of the research
Voluntary Participation: No pressure, coercion, or excessive incentives should influence your decision
Privacy Protection: Your medical information must be kept confidential
Right to Information: You should receive updates about the study and your results when appropriate

Important: Unlike research in non-pregnant adults, pregnancy studies must demonstrate either direct benefit to you and your baby OR pose only minimal risk while generating important knowledge that cannot be obtained any other way.

Studies conducted in the United States provide additional protections under FDA regulations, including mandatory maternal-fetal medicine expertise and enhanced oversight for pregnant women. International studies may have different but equally important protections under their local regulatory systems.

What support services are available?

Why would I want to be part of a clinical trial?

There are many reasons you might consider enrolling in a clinical trial for HG.

The following possible reasons may help guide your decision making about if a trial if right for you:

I am not responding to current treatment and can't access other options.
I want to be part of the solution, so others have better treatment options than I did.
I may be able to get more medication and monitoring in a clinical trial.
Participating in research makes me feel like I'm doing something proactive about my condition instead of just suffering through it.
I want to contribute to scientific discovery that could change how HG is understood and treated.

Take time to consider your interest in a trial:

What do I hope to gain from participating in a clinical trial?
How important is helping future HG mothers to me?
Am I comfortable with uncertainty about whether a new treatment will help?
Can I handle the time and travel commitments required?
How does my family feel about my participation?
How do I feel about the risks of current treatment compared to the clinical trial therapeutic?

What risks and challenges should I consider when deciding about clinical trials?

A clinical trial often involves therapeutics that do not have a history of safety data to review and compare with current treatments. Following are some risks and challenges to reflect on as you make your decision:

Unknown Side Effects: New treatments may have unforeseen effects on you or your baby
Randomization: You might be assigned to receive placebo or standard care instead of the experimental treatment
Treatment May Not Work: Experimental approach might be less effective than current care
Time and Travel: Multiple clinical trial site visits and lengthy appointments
Additional Procedures: Extra blood draws, monitoring, and medical assessments
Privacy Considerations: Detailed medical information collection and potential data sharing
Emotional Impact: Uncertainty about treatment effectiveness
Post-Study Access: Experimental treatment may not be available after the trial ends

Note: All studies have strict protocols on data sharing and confidentiality.

Thinking about participating in a clinical trial?

Costs Typically Covered by a Study

FAQs for Mothers

FAQs for Family & Friends

FAQ on Future Pregnancies

FAQ Medication

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