ClinicalTrials.gg
CompletedNCT02322177Updated Oct 26, 2026

Maternal Inborn Errors of Metabolism in Pregnancy: A Pregnancy Registry Protocol

An observational study in Inborn Errors of Metabolism, Pregnancy and Acidemias, sponsored by National Human Genome Research Institute (NHGRI). Completed at 2 sites in United States. Open to female participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Human Genome Research Institute (NHGRI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2
Ages
14 Years to 50 Years
Sex
Female
01

Study summary

Background:

- People with inborn errors of metabolism can t turn food into energy the right way. This can affect a person s growth and health. Researchers want to know how this condition affects a pregnant woman and her baby.

Objectives:

- To collect data from the medical records of women with an inborn error of metabolism. Also, to create a pregnancy registry of inborn errors of metabolism.

Eligibility:

  • Women with an inborn error of metabolism who either:
  • have been pregnant in the past,
  • are currently pregnant, or
  • have recently talked with their doctor about becoming pregnant.

Design:

  • This study will collect data only. No extra tests will be done.
  • Participants will be in the study for the length of their pregnancy and for 1 year after delivery.
  • Participants will answer questions about their family s health.
  • The participant s doctor will send their medical records to researchers. These may include data about:
  • Last health care visit before pregnancy
  • Blood, urine, ultrasound, or lab results during pregnancy
  • Delivery and recovery after delivery
  • Researchers will ask for the test(s) used to confirm pregnancy.
  • After the participant has her baby, researchers will ask for data about how the baby is doing. This may include when the baby is sitting, walking, talking, etc.
  • The data will be placed into a database. The database will not include the participant s name or identifying data.
Read the detailed description

Women with inherited metabolic disorders are reaching child bearing age more often due to advances in early diagnosis and improved pediatric care. For many of these disorders, there is very little information in the literature to guide the counseling and treatment of these patients and their pregnancies.

The most information for the effects of an underlying inborn error of metabolism in pregnancy derives from the study of phenylketonuria (PKU). From the knowledge gained through the collection of information from multiple cases of pregnancy affected by PKU, important management issues were identified. For example, children born to mothers with an unrestricted diet were substantially more likely to have intellectual disability, microcephaly, and low birth weights than women who maintained a phenylalanine restricted diet. The excess phenylalanine poses long-term health risks to the developing fetus and now a vigilant metabolic approach is recognized as mandatory in women with PKU desiring pregnancy.

Compared to PKU, most or all other intermediary metabolic disorders have been understudied. For example, there are nine published cases of methylmalonic acidemia (MMA) in pregnancy and one case of cobalamin C deficiency in pregnancy, and review articles have reported the same cases. For other inborn errors of metabolism there is even less published or known. The paucity of publication of pregnancy in IEMs other than PKU may be due to the lack of organized research to address pregnancy management in metabolic disorders.

The objective of this study is to establish a pregnancy registry of women with inborn errors of metabolism other than PKU. We will collect management plans, baseline laboratory values, prenatal and postpartum course including metabolic and obstetrical issues, and fetal/neonatal outcomes. This study will also investigate reproductive issues including infertility and use of artificial reproductive technologies. A registry of this type will allow physicians and patients to report varying management and outcomes, both positive and negative, with the broader goal of delineating optimal maternal and fetal outcomes for these unique patient populations. Our registry data would also serve as a vehicle to disseminate management experience for all providers, recognizing that individual centers may not have sufficient experience to make accurate management decisions on their own.

02

Conditions studied

  • Inborn Errors of Metabolism
  • Pregnancy
  • Acidemias

Keywords

  • Inborn Error of Metabolism
  • Pregnancy
  • Amino acid disorder
  • Fatty acid oxidation disorder
  • Organic Acidemia
  • Natural History
03

In context

Metabolism, Inborn Errors

152 studies on the registry are indexed under Metabolism, Inborn Errors; 22 are open to participants now.

This study's enrollment of 2 is below the median of 65 across 45 observational studies indexed under Metabolism, Inborn Errors.

Browse Metabolism, Inborn Errors studies →

Lead sponsor

National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants are women with inborn errors of metabolism who have been pregnant

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients clinically diagnosed with methylmalonic acidemia or another inborn error of metabolism are eligible to participate; mutational and enzymatic status is preferred but not required. Biochemical testing is required.
  • Women with inborn errors of metabolism who have had a clinically documented prior pregnancy, currently are pregnant or planning a pregnancy.

Exclusion criteria

EXCLUSION CRITERIA:

  • Patients with phenylketonuria or hyperphenylalaninemia.
  • Anyone unwilling to provide (for themselves as adults, or on behalf of their children as minors) or assent.
  • Medical condition(s) or mental retardation are not in themselves reason for exclusion if in the judgment of the referring physician this would involve no more than minimal risk. We will make every effort to explain the study for the purpose of assent in a manner that the family feels is both age and developmentally appropriate for that child.
  • We will review a clinical description from the referring physician about a potential research subject to determine that the subject is appropriate to enter into the study. We reserve the right to exclude cases that are not definitively diagnosed by metabolites and/or molecular genetics or related to our direct research interests. We expect this to be a rare minority.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2 participants (actual)

Groups and cohorts

  • 1

    Participants are women with inborn errors of metabolism who have been pregnant

06

What researchers measure

Primary outcomes

  1. Maternal inborn errors of metabolism

    Time frame: Yearly

07

Study locations

2 sites
  • National Human Genome Research Institute (NHGRI)
    Bethesda, Maryland 20892, United States
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Kuseyri O, Weissbach A, Bruggemann N, Klein C, Gizewska M, Karall D, Scholl-Burgi S, Romanowska H, Krzywinska-Zdeb E, Monavari AA, Knerr I, Yapici Z, Leuzzi V, Opladen T. Pregnancy management and outcome in patients with four different tetrahydrobiopterin disorders. J Inherit Metab Dis. 2018 Sep;41(5):849-863. doi: 10.1007/s10545-018-0169-0. Epub 2018 Mar 28. PubMed 29594647 ↗
  • Raval DB, Merideth M, Sloan JL, Braverman NE, Conway RL, Manoli I, Venditti CP. Methylmalonic acidemia (MMA) in pregnancy: a case series and literature review. J Inherit Metab Dis. 2015 Sep;38(5):839-46. doi: 10.1007/s10545-014-9802-8. Epub 2015 Jan 8. PubMed 25567501 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Aug 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2014
First posted
Dec 23, 2014
Start
Dec 19, 2014
Primary completionActual
Aug 20, 2018
CompletionActual
Aug 20, 2018
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02322177
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Dec 19, 2014
Primary completion
Aug 20, 2018
Completion
Aug 20, 2018
Last update
Oct 26, 2026

Study contacts

Charles P Venditti, M.D.
principal investigator · National Human Genome Research Institute (NHGRI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion