Twin Twin Transfusion SyndromeNCT02122328
Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
A study testing Sequential laser photocoagulation of communicating vessels. and Selective laser photocoagulation of communicating vessels in people with Twin Twin Transfusion Syndrome, run by University of Southern California at 1 site in United States.
Trial summary
The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Twin Transfusion Syndrome
- What is being tested?
- Sequential laser photocoagulation of communicating vessels. and Selective laser photocoagulation of communicating vessels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2010to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
- 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).
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- 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.
Who cannot join
- Patients unable or unwilling to participate in the study or to be followed up.
- Patients unable to give written informed consent.
- Presence of major congenital anomalies that may not warrant surgery.
- Known unbalanced chromosomal complement.
- Prior intentional septostomy (purposely making a hole in the dividing membrane).
- Ruptured membranes.
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- Chorioamnionitis.
- Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atrium 10-19 mm) may or may not be used as exclusion criteria.
- Placental abruption.
- Active labor.
- Patient unwilling to receive blood products.
- Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of the median (indicative of fetal anemia).
- Any other patient deemed inappropriate for the study by the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollywood Presbyterian Medical Center
Los Angeles, California, 90027
About this study
Official title: USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.
- Conditions
- Twin Twin Transfusion Syndrome
- Being tested
- Sequential laser photocoagulation of communicating vessels., Selective laser photocoagulation of communicating vessels
- Keywords
- Twin twin transfusion syndrome, Sequential laser photocoagulation of communicating vessels
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential laser photocoagulation of communicating vessels.Procedure or surgery
Selective laser photocoagulation of communicating vesselsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Selective procedure | Active comparator | Selective laser photocoagulation of communicating vessels. Receives: Procedure: Selective laser photocoagulation of communicating vessels |
| Sequential procedure | Experimental | Sequential laser photocoagulation of communicating vessels Receives: Procedure: Sequential laser photocoagulation of communicating vessels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.
Measured: Birth
Secondary outcomes (1)
Surgical complications
Measured: 21 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study start9 Jun 2010
- Primary completion30 Apr 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Twin Transfusion SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramen Chmait, University of Southern California
- Investigators
- Ramen Chmait, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122328
- Sponsor's protocol ID
- HS-09-00680
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2014
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
- ClinicalTrials.gov ID
- NCT02122328
- Acronym / sponsor ID
- HS-09-00680
- Conditions
- Twin Twin Transfusion Syndrome
- Keywords
- Twin twin transfusion syndrome, Sequential laser photocoagulation of communicating vessels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 9 Jun 2010 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective procedure | Active comparator | Procedure: Selective laser photocoagulation of communicating vesselsSelective laser photocoagulation of communicating vessels. |
| Sequential procedure | Experimental | Procedure: Sequential laser photocoagulation of communicating vessels.Sequential laser photocoagulation of communicating vessels |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
- Confirmed TTTS patients, who by definition meet the following sonographic criteria:
- 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.
Key exclusion criteria (13 listed)
- Patients unable or unwilling to participate in the study or to be followed up.
- Patients unable to give written informed consent.
- Presence of major congenital anomalies that may not warrant surgery.
- Known unbalanced chromosomal complement.
- Prior intentional septostomy (purposely making a hole in the dividing membrane).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential laser photocoagulation of communicating vessels. | Procedure or surgery | Sequential procedure |
| Selective laser photocoagulation of communicating vessels | Procedure or surgery | Selective procedure |
Primary outcome
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
Time frame: Birth
A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.
1 secondary outcome
Surgical complications
Time frame: 21 post-operative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
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The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramen Chmait, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential laser photocoagulation of communicating vessels. and Selective laser photocoagulation of communicating vessels in people with Twin Twin Transfusion Syndrome, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV. (time frame: Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.