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Laser surgery in the womb could let moms with vasa previa deliver naturally

NCT ID NCT06290232

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 looked at a fetal surgery called fetoscopic laser photocoagulation (FLP) to treat vasa previa, a condition where fetal blood vessels cover the womb opening, making vaginal delivery dangerous. The goal was to seal off these vessels to prevent bleeding and allow a safer delivery, possibly without a C-section. However, the study was withdrawn before enrolling any participants, so no results are available.

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.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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 55 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: * Pregnant patient * Singleton pregnancy * Confirmed diagnosis of vasa previa, defined as unprotected fetal vessels running through the membranes at or within 5cm of the internal cervical os. Diagnosis must be confirmed after 26w0d, and before 32w5d * Able to undergo intervention during 30w0d to 32w6d * Type II vasa previa in which one placental lobe is considered to be accessory, defined as constituting less than 20% of the total placental mass seen on MRI and US imaging * Type II vasa previa in which multiple bridging vessels connect the two placental lobes (≥4 vessels), and only 1-2 vessel(s) run through or within 5cm of the internal cervical os * Patient is eligible to undergo anesthesia * Patient and biological father of the fetus (if available) are able to provide signed informed consent Exclusion Criteria: * Gestational age at referral higher than 32w6d * Multiple pregnancy * Vasa previa types I and III * Type II vasa previa in which the accessory lobe constitutes more than 20% of the total placental mass, as determined by the fetal surgeon during diagnostic fetoscopy * Type II vasa previa in which all of the bridging vessels between placental lobes are running over the internal cervical os * Fetal growth restriction, defined as estimated fetal weight or abdominal circumference less than the 10th percentile for gestational age * Abnormal fetal brain MRI, including delayed maturation, hemorrhage, arterial ischemic injury, abnormal ventricular size, or any congenital anomalies * Allergy or previous adverse reaction to ancillary medications with no available alternative * Preterm contractions and PPROM before surgery * Preeclampsia or uterine anomaly during the current pregnancy * Placenta previa, low-lying placenta, placenta accreta spectrum disorder * Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life * Maternal pre-pregnancy BMI \>40 * Active hepatitis B, hepatitis C, or HIV infection * High risk for congenital fetal bleeding disorders * Unreliable pregnancy dating due to an irregular menstrual cycle/uncertain last menstrual period with no confirmed dating from first trimester ultrasound * The surgeon determines that the procedure is not feasible for any other reason after diagnostic fetoscopy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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