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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
Confirmed TTTS patients, who by definition meet the following sonographic criteria: Single placenta. Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage. Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage. Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic). Same gender, if visible. Quintero Stages 1-4. Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included. Patients with an anterior placenta may be included. Triplet gestations with two or three fetuses sharing the same placenta may be included. Patients must be able to give written informed consent.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 6 months of life
Awards & highlights

Study Summary

This trial is comparing two methods of treating TTTS to see which one is better. The first method is SQLPCV and the second is SLPCV. They are comparing the perinatal outcomes of each method.

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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant with twins or triplets sharing a placenta and have TTTS with specific ultrasound findings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 6 months of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 6 months of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
Secondary outcome measures
Surgical complications
Other outcome measures
Fetal/neonatal/infant outcomes

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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,594,661 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.

Media Library

Selective laser photocoagulation of communicating vessels (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02122328 — N/A
Twin-Twin Transfusion Syndrome Research Study Groups: Selective procedure, Sequential procedure
Twin-Twin Transfusion Syndrome Clinical Trial 2023: Selective laser photocoagulation of communicating vessels Highlights & Side Effects. Trial Name: NCT02122328 — N/A
Selective laser photocoagulation of communicating vessels (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02122328 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this trial at this time?

"As indicated by the clinicaltrials.gov website, this experiment is enlisting participants and has been doing so since June 1st 2010 with its most recent update occurring on May 6th 2022."

Answered by AI

What is the total number of individuals participating in this research project?

"Affirmative, the clinicaltrials.gov website states that recruitment for this research project is still active. Initially posted on June 1st 2010 and last updated on May 6th 2022, the trial has a goal of enrolling 542 participants at one location."

Answered by AI

Could I be involved with this medical experiment?

"The requirements for entry into this medical research are twin-twin transfusion syndrome and an age between 16 to 55. Upwards of 542 individuals will be accepted in the trial."

Answered by AI

Does this research incorporate participants who are older than 30?

"This medical experiment has a strict age limit of 16-55 years old, with 377 trials available for minors and 989 studies open to individuals over 65."

Answered by AI
~44 spots leftby Mar 2025