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New shot aims to stop dangerous pregnancy condition before it starts

NCT ID NCT07384936

Prevention Sponsor: Fang Wang Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an injection called topefilgrastim in 100 pregnant women at high risk for preeclampsia, a serious condition that can harm both mother and baby. Participants are split into two dose groups or a control group to see if the drug can lower the chance of developing preeclampsia. The main goal is to measure changes in key blood markers linked to the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily participate in the study, be able to understand, and sign the informed consent form. * Aged 18 to 45 years (inclusive) at the time of signing the informed consent form. * Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either: A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details) * Gestational weeks 11-13 at enrollment. * Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound). Exclusion Criteria: * History of psychiatric disorder not adequately controlled by medication. * Unexplained vaginal bleeding at screening. * Known uterine malformation. * Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis. * Known proliferative retinopathy. * Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation. * Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium. * Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.

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Conditions

The condition(s) this trial relates to.

preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lanzhou University Second Hospital

    Lanzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.