ClinicalTrials.gg
Not yet recruitingNCT07832513Updated Sep 22, 2026

Study of Pregnancy in Patients With Myeloproliferative Neoplasms

An observational study in Myeloproliferative Neoplasm (MPN) and Pregnancy, sponsored by University Health Network, Toronto. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
Female
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Study summary

This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm

02

Conditions studied

  • Myeloproliferative Neoplasm (MPN)
  • Pregnancy
03

In context

Myeloproliferative Disorders

668 studies on the registry are indexed under Myeloproliferative Disorders; 111 are open to participants now.

This study's planned enrollment of 30 is below the median of 150 across 115 observational studies indexed under Myeloproliferative Disorders.

Browse Myeloproliferative Disorders studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with MPN who are 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 with a diagnosis of chronic phase essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic or overt primary myelofibrosis (PMF), post-ET myelofibrosis (MF), post-PV MF, or myeloproliferative neoplasm (MPN) - unclassifiable according to the 2022 International Consensus Criteria. Patients who have not had a diagnostic bone marrow may participate if there is a driver mutation and all other diagnostic criteria are met.
  • Patients with a confirmed pregnancy through Beta Human Chorionic Gonadotropin (BHCG) testing of the urine or blood and/or dating ultrasound. Patients may be eligible to participate at any stage of pregnancy.
  • Patients must have the ability to participate in study procedures.
  • Participants must provide consent to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • Patients with a diagnosis of chronic myeloid leukemia, myelodysplastic syndrome (MDS), MDS/MPN overlap syndrome, or other myeloid .
  • Peripheral blood or marrow blasts >/= 10%.
  • Patients with concurrent disease that in the opinion of the investigator may be adversely impact the safety of the patient or impair assessment of study results, including but not limited to:
  • Uncontrolled diseases (e.g., hepatitis, immune thrombocytopenic purpura [ITP], scleroderma, autoimmune arthritis)
  • Active, uncontrolled infection (e.g., , , )
  • Second malignancy requiring concurrent treatment, except basal cell carcinoma or squamous cell carcinoma or cervical carcinoma in situ.
  • Patients requiring a legally authorized representative.
Terms in these criteria, in plain language(6)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with myeloproliferative neoplasms and are pregnant

    Other: Risk-adapted algorithm

Interventions

  • OtherRisk-adapted algorithm

    The risk-based algorithm is based on expert consensus and has been well-described in review articles and educational sessions at major conferences.

06

What researchers measure

Primary outcomes

  1. Proportion of pregnancies resulting in live birth

    Time frame: 3 years

Secondary outcomes

  1. Number of perinatal venous thrombotic events

    Time frame: 3 years

  2. Number of arterial thromboembolic events

    Time frame: 3 years

  3. Number of perinatal major bleeding events

    Time frame: 3 years

  4. Proportion of participant deaths from any cause, starting from the beginning of the pregnancy up until 12 weeks after the pregnancy ends.

    Time frame: 3 years

  5. Number of hypertensive disorder events of pregnancy at less than 34 weeks

    Time frame: 3 years

  6. Number of hypertensive disorder events of pregnancy at greater than 34 weeks

    Time frame: 3 years

  7. Number of participants diagnosed with placental insufficiency

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 37 observational studies under Myeloproliferative Disorders, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's planned 24 months is below that.

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

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartEst.
Oct 5, 2026
Primary completionEst.
Oct 5, 2028
CompletionEst.
Oct 5, 2028
Last update
Sep 22, 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 Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832513
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Oct 5, 2026 (estimated)
Primary completion
Oct 5, 2028 (estimated)
Completion
Oct 5, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Dawn Maze, MD, FRCPC, MSc.
Contact
dawn.maze@uhn.ca
416-946-4501 ext. 5845
Dawn Maze, MD, FRCPC, MSc.
principal investigator · The Princess Margaret Cancer Foundation
Nadine Shehata, MD, FRCPC, MSc.
principal investigator · Sinai Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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