What side effects are associated with this type of intervention?

The most common treatments for Twin-Twin Transfusion Syndrome (TTTS), such as Sequential Laser Photocoagulation of Communicating Vessels (SQLPCV), are associated with side effects including preterm premature rupture of membranes (PPROM), preterm labor, infection, and fetal demise. There is also a risk of incomplete coagulation, which can lead to recurrent TTTS or twin anemia-polycythemia sequence (TAPS).

What prior FDA approvals exist?

The primary FDA-approved treatment for Twin-Twin Transfusion Syndrome (TTTS) is laser photocoagulation of the communicating vessels, specifically Selective Laser Photocoagulation of Communicating Vessels (SLPCV). This procedure involves using a laser to coagulate the blood vessels that connect the circulations of the twins, thereby stopping the transfusion imbalance. Sequential Laser Photocoagulation of Communicating Vessels (SQLPCV) is a variation of this technique, aiming to provide better vascular stability to the donor fetus by sequentially targeting the vessels. While SQLPCV itself may not yet be FDA-approved, it builds on the established principles of SLPCV, which is the standard treatment for TTTS.

What other types of research exist?

Promising novel alternatives to Sequential Laser Photocoagulation of Communicating Vessels (SQLPCV) for Twin-Twin Transfusion Syndrome (TTTS) patients include: 1) Selective Laser Photocoagulation of Communicating Vessels (SLPCV), which targets only the vessels directly responsible for TTTS, potentially reducing procedure time and complications. 2) Fetoscopic Laser Surgery with advanced imaging techniques, which enhances precision in identifying and coagulating the problematic vessels. 3) Radiofrequency Ablation (RFA), which uses heat to close off the vessels and may offer a less invasive option with fewer risks of preterm labor. These alternatives are being explored for their efficacy and safety in improving perinatal outcomes for TTTS patients.

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Procedure

Sequential vs. Standard Laser Treatment for TTTS

N/A

Waitlist Available

Led By Ramen Chmait, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Presence of major congenital anomalies that may not warrant surgery.

Prior intentional septostomy (purposely making a hole in the dividing membrane).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special laser treatment for pregnant women with TTTS. The treatment seals abnormal blood vessels between twins in a specific order to stabilize blood flow and improve survival chances for the donor twin. This laser treatment is now the preferred method for twin-twin transfusion syndrome (TTTS).

Who is the study for?

This trial is for pregnant individuals with confirmed twin-twin transfusion syndrome (TTTS) between 16 and 26 weeks of gestation. Eligible participants have a single placenta, specific fluid levels in each twin's sac, and are carrying twins or triplets sharing the same placenta. They must consent to treatment and follow-up. Exclusions include active labor, certain fetal conditions like anemia or congenital anomalies, ruptured membranes, unwillingness to receive blood products, or any criteria making them unsuitable as decided by the investigator.

What is being tested?

The study compares two laser treatments for TTTS: sequential (SQLPCV) versus selective (SLPCV) photocoagulation of vessels connecting the twins' circulations. The goal is to see if SQLPCV improves survival rates for the donor fetus compared to SLPCV in a controlled experiment where patients are randomly assigned one of these treatments.

What are the potential side effects?

While not explicitly listed here, side effects may include complications from laser surgery such as bleeding or damage to surrounding tissues; risks associated with any surgical procedure under anesthesia; potential adverse outcomes for either fetus due to changes in blood flow dynamics post-procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a major birth defect that doesn't require surgery.

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I have had a procedure to intentionally create a hole in the heart's dividing wall.

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I have an abnormal number of chromosomes.

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My unborn baby has abnormal brain ultrasound findings.

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I am unable to sign a consent form.

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I am not willing to receive blood transfusions.

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I am willing and able to participate in the study and follow-up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sequential procedureExperimental Treatment1 Intervention

Sequential laser photocoagulation of communicating vessels

Group II: Selective procedureActive Control1 Intervention

Selective laser photocoagulation of communicating vessels.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Twin-Twin Transfusion Syndrome (TTTS) involve laser photocoagulation techniques, such as Sequential Laser Photocoagulation of Communicating Vessels (SQLPCV) and Selective Laser Photocoagulation of Communicating Vessels (SLPCV). SQLPCV works by sequentially coagulating the abnormal blood vessels between the twins, providing vascular stability to the donor fetus and improving intrauterine survival rates. SLPCV selectively targets specific vessels to achieve similar outcomes. These treatments are crucial for TTTS patients as they help to balance blood flow between the twins, thereby reducing complications and improving perinatal outcomes.

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

946 Previous Clinical Trials

1,603,977 Total Patients Enrolled

Ramen Chmait, MD5.013 ReviewsPrincipal Investigator - University of Southern California

University of Southern California

3 Previous Clinical Trials

182 Total Patients Enrolled

5Patient Review

Dr. Chmait and his team are excellent. My daughter-in-law was pregnant with twins and diagnosed with TTTS, but surgery was a success thanks to him. He's very compassionate and empathetic, which we appreciate.