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Laser surgery or watchful waiting? trial seeks best care for twin syndrome

NCT ID NCT01220011

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compared two approaches for twin-to-twin transfusion syndrome (TTTS) stage 1: immediate laser surgery versus careful observation. 179 pregnant women with TTTS stage 1 and favorable conditions took part. The goal was to see which strategy leads to better survival and brain health for the babies at 6 months of age.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fetoscopic laser surgery
What this could lead to
If laser surgery proves better, it could become the standard treatment for early-stage TTTS, improving survival and reducing brain damage in twins.
What could go wrong
This is a completed trial with 179 participants, so results are limited. Laser surgery carries risks like preterm labor or infection, and the benefit over observation may be small or none.

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

179 people

The number who actually took part.

Started

Apr 2011

Finished

Mar 2019

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 years and older

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: * TTTS stage 1 (Euro foetus criteria) * Gestational age \> 16 and \< 26 weeks * Age \> 18 * Informed consent Exclusion Criteria: * Therapeutic amniocentesis prior to referral * Short cervix \< 15 mm on transvaginal US * Severe maternal discomfort:Dyspnea and orthopnea, Abdominal pain \> 4 on a 10-level visual analogic pain scale, Contractions \> 1 per hour * PPROM * Fetal malformations unrelated to TTTS * Follow-up is impossible

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Conditions

The condition(s) this trial relates to.

hematologic disorder Infant, Newborn, Diseases neonatal anemia perinatal disease twin to twin transfusion syndrome

As listed by the trial registrant

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

Anemia neonatal Blood and blood disorders Hematologic disease Infant, newborn, diseases

Contacts and locations

Locations

  • Children's Hospital Colorado and Colorado Fetal Care Center

    Aurora, Colorado, 80045, United States

  • Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3026, United States

  • Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Fetal Therapy Program, Evergrenn Hospital Medical Center

    Kirkland, Washington, 98034, United States

  • Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University.

    Providence, Rhode Island, 02903, United States

  • Hospital Ste-Justine

    Montreal, Quebec, H3T 1R2, Canada

  • Mount Sinai Hospital, University of Toronto

    Toronto, Ontario, ON M5X 1X5, Canada

  • Necker Enfants Malades

    Paris, 75006, France

  • The Ohio State University / OSU Fetal Therapy Program

    Columbus, Ohio, 43221, United States

  • The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School

    Houston, Texas, 77030, United States

  • University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences

    Baltimore, Maryland, 21000, United States

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