Twin to Twin Transfusion SyndromeNCT00345852
Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
A study testing Fetoscopic Selective Laser Photocoagulation in people with Twin to Twin Transfusion Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 12 sites in United States.
Trial summary
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin to Twin Transfusion Syndrome
- What is being tested?
- Fetoscopic Selective Laser Photocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2002to May 2007
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both twins are alive
- TTTS diagnosed prior to 22 weeks gestation
- Monochorionic diamniotic gestation
- Like sex twins
- Single placental mass
- Thin intertwin membrane
Show all 13Show fewer
- Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm)
- Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction)
- Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present
- No associated structural abnormalities
- No sonographic evidence of CNS injury at time of entry
- No preterm labor
- No maternal medical contraindication to anesthesia or surgery
Who cannot join
- Failure to meet all inclusion criteria
- TTTS presenting after 22 weeks gestation
- Randomization after 24 weeks gestation
- Cervical length < 2.0 cm post initial
- Presence of cervical cerclage
- Uterine anomaly
Show all 9Show fewer
- Refusal to accept randomization
- Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions
- Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
University of Texas Medical Branch
Galveston, Texas, 77555
New York University School of Medicine
New York, New York, 10016
Columbia-Presbyterian Medical Center
New York, New York, 10032
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213
University of Utah Hospital
Salt Lake City, Utah, 84143
University of California-San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.
Read the detailed description
We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity
- Conditions
- Twin to Twin Transfusion Syndrome
- Being tested
- Fetoscopic Selective Laser Photocoagulation
- Keywords
- twin to twin transfusion syndrome, fetoscopic selective laser photocoagulation, amnioreduction
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic Selective Laser PhotocoagulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of donor twin at 30 days after birth and no treatment failure
Survival of recipient twin at 30 days after birth and no treatment failure
Secondary outcomes (6)
Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Gestational age at delivery
Placental insufficiency
Cardiac outcome: echocardiographic evidence of cardiac compromise
Neurologic outcome: evidence of brain injury preceding birth by MRI
Postnatal comorbidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startMar 2002
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin to Twin Transfusion SyndromeStudies of the same condition, open and under way.
- 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
- 150 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Investigators
- Timothy M Crombleholme, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345852
- Sponsor's protocol ID
- R01HD041149
- Status last verified
- Jun 2006
- First submitted
- 27 Jun 2006
- Last updated
- 29 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
- ClinicalTrials.gov ID
- NCT00345852
- Acronym / sponsor ID
- R01HD041149
- Conditions
- Twin to Twin Transfusion Syndrome
- Keywords
- twin to twin transfusion syndrome, fetoscopic selective laser photocoagulation, amnioreduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Mar 2002
- Study completion
- May 2007
- First posted
- 29 Jun 2006 (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.
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.
Detailed description
We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Both twins are alive
- TTTS diagnosed prior to 22 weeks gestation
- Monochorionic diamniotic gestation
- Like sex twins
- Single placental mass
Key exclusion criteria (9 listed)
- Failure to meet all inclusion criteria
- TTTS presenting after 22 weeks gestation
- Randomization after 24 weeks gestation
- Cervical length < 2.0 cm post initial
- Presence of cervical cerclage
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 |
|---|---|---|
| Fetoscopic Selective Laser Photocoagulation | Procedure or surgery | – |
Primary outcome
Survival of donor twin at 30 days after birth and no treatment failure
Survival of recipient twin at 30 days after birth and no treatment failure
6 secondary outcomes
Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Gestational age at delivery
Placental insufficiency
Cardiac outcome: echocardiographic evidence of cardiac compromise
Neurologic outcome: evidence of brain injury preceding birth by MRI
Postnatal comorbidity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2007.
- Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpageLink provided by the sponsor.
Related trials for Twin to Twin Transfusion Syndrome
Active, not recruitingObservational study
Database of Monochorionic Pregnancies
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Recruiting
The Effect of Uterine Entry In Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
Twin to Twin Transfusion
Not yet recruiting
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Twin to Twin Transfusion Syndrome
Recruiting
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence
Recruiting
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Fetal Conditions, Maternal; Procedure
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.
Timothy M Crombleholme, MD principal investigator
Children's Hospital Medical Center, Cincinnati
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic Selective Laser Photocoagulation in people with Twin to Twin Transfusion Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 12 sites 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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
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?
Survival of donor twin at 30 days after birth and no treatment failure. The study lists 2 primary outcomes in all. 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 29 Jun 2007.