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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:Select...
I have a major birth defect that doesn't require surgery.
Select...
I have had a procedure to intentionally create a hole in the heart's dividing wall.
Select...
I have an abnormal number of chromosomes.
Select...
My unborn baby has abnormal brain ultrasound findings.
Select...
I am unable to sign a consent form.
Select...
I am not willing to receive blood transfusions.
Select...
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
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.
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.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
940 Previous Clinical Trials
1,613,905 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major birth defect that doesn't require surgery.I have had a procedure to intentionally create a hole in the heart's dividing wall.I am pregnant with twins or triplets sharing a placenta and have TTTS with specific ultrasound findings.I have an abnormal number of chromosomes.The doctor in charge of the study decides that you are not a good fit for the study.My unborn baby has abnormal brain ultrasound findings.Your water has broken.I am unable to sign a consent form.You have experienced separation of the placenta from the uterus before the baby is born.I am not willing to receive blood transfusions.I am willing and able to participate in the study and follow-up.
Research Study Groups:
This trial has the following groups:- Group 1: Selective procedure
- Group 2: Sequential procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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