Twin Twin Transfusion SyndromeTTTSNCT01622049
Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome
An observational study of Twin Twin Transfusion Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Twin Twin Transfusion Syndrome
- What is being tested?
- Selective Laser Photocoagulation of Communicating Vessels
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Feb 2009
- Phase
- Observational
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible, patients must meet the following criteria:
- Maternal age 18 to 55 years
- 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.
Show all 26Show fewer
- 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.
- 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. Inclusion Criteria 5.2 Exclusion Criteria
- The following criteria would exclude patients from participation in the study:
- 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.
- 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 an exclusion criteria.
- Placental abruption.
- Active labor.
- Jehovah's Witness.
- Any other patient deemed inappropriate for the study by the principal investigator.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be delivered fresh to Tampa General Hospital in an icebox container for assessment. Placentas will be discarded after analysis.
- Conditions
- Twin Twin Transfusion Syndrome
- Being tested
- Selective 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.
Selective Laser Photocoagulation of Communicating VesselsDevice
Also called SLPCV
Patients will be admitted to Tampa General Hospital. Laboratory tests and anesthesia assessments will be completed. Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. Surgery will be performed preferably under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. Surgery will be performed with standard operative fetoscopy equipment and techniques. A trocar will be introduced in the amniotic cavity of the recipient. An amniotic fluid sample will be obtained for microbiological studies, and genetic analysis for clinical care only. The amniotic fluid will be discarded after analysis. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted. An amniodrainage of the larger sac may be performed
| Study group | Role | What they receive |
|---|---|---|
| TTTS treatment method | This is an observational trial. Patients who meet eligibility criteria and give written informed consent will have SLPCV. All subjects will receive ongoing standard-of-care prenatal care for the duration of their pregnancy from their referring perinatologist or obstetrician. Receives: Device: Selective Laser Photocoagulation of Communicating Vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study objective is to evaluate neonatal/infant survival 6 months after birth.
Measured: 6 months
Secondary outcomes (1)
The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startOct 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Twin Twin Transfusion SyndromeStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Observational
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben A Quintero, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622049
- Sponsor's protocol ID
- #105118
- Acronym
- TTTS
- Status last verified
- Nov 2012
- First submitted
- 5 Aug 2010
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chmait RH, Kontopoulos EV, Korst LM, Llanes A, Petisco I, Quintero RA. Stage-based outcomes of 682 consecutive cases of twin-twin transfusion syndrome treated with laser surgery: the USFetus experience. Am J Obstet Gynecol. 2011 May;204(5):393.e1-6. doi: 10.1016/j.ajog.2011.02.001. Epub 2011 Mar 15.
PubMed 21411051
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome
- ClinicalTrials.gov ID
- NCT01622049
- Acronym / sponsor ID
- TTTS / #105118
- Conditions
- Twin Twin Transfusion Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Jun 2012 (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.
Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be delivered fresh to Tampa General Hospital in an icebox container for assessment. Placentas will be discarded after analysis.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTTS treatment method | – | Device: Selective Laser Photocoagulation of Communicating VesselsThis is an observational trial. Patients who meet eligibility criteria and give written informed consent will have SLPCV. All subjects will receive ongoing standard-of-care prenatal care for the duration of their pregnancy from their referring perinatologist or obstetrician. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Maternal age 18 to 55 years
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Selective Laser Photocoagulation of Communicating VesselsAlso: SLPCVPatients will be admitted to Tampa General Hospital. Laboratory tests and anesthesia assessments will be completed. Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. Surgery will be performed preferably under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. Surgery will be performed with standard operative fetoscopy equipment and techniques. A trocar will be introduced in the amniotic cavity of the recipient. An amniotic fluid sample will be obtained for microbiological studies, and genetic analysis for clinical care only. The amniotic fluid will be discarded after analysis. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted. An amniodrainage of the larger sac may be performed | Device | TTTS treatment method |
Primary outcome
The primary study objective is to evaluate neonatal/infant survival 6 months after birth.
Time frame: 6 months
1 secondary outcome
The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth
Time frame: 6 months
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 14 Mar 2013.
- Results publication: PubMed 21411051Chmait RH, Kontopoulos EV, Korst LM, Llanes A, Petisco I, Quintero RA. Stage-based outcomes of 682 consecutive cases of twin-twin transfusion syndrome treated with laser surgery: the USFetus experience. Am J Obstet Gynecol. 2011 May;204(5):393.e1-6. doi: 10.1016/j.ajog.2011.02.001. Epub 2011 Mar 15.
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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.
Ruben A Quintero, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Twin Transfusion Syndrome, run by University of South Florida 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 26 inclusion and 0 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 14 Mar 2013. 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?
The primary study objective is to evaluate neonatal/infant survival 6 months after birth. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622049, which also lists 1 linked publication.
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 14 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.