Twin to Twin Transfusion as Antepartum ConditionNCT05008744
Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome
An observational study of Twin to Twin Transfusion as Antepartum Condition and Monochorionic Diamniotic Placenta, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Twin to Twin Transfusion as Antepartum Condition, Monochorionic Diamniotic Placenta
- What is being tested?
- Fetoscopic laser ablation
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2031
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant persons presenting with a diagnosis of twin to twin transfusion syndrome
Who may be able to join
- Single placenta (Monochorionic)
- Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
- Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
- Prominent bladder in the recipient/ non-filling bladder in the donor
- Thin dividing membrane
Who cannot join
- Patients unwilling to participate in the study or to be followed up
- Presence of major congenital anomalies incompatible with survival
- Active pre-term labor Ruptured membranes
- Chorioamnionitis
- Vaginal bleeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Seattle Childrens Hospital
Seattle, Washington, 98015
Martin P Walker, MD, 206-987-3539 ext. 73539, martin.walker@seattlechildrens.org
- Active, not recruiting
University of Washington
Seattle, Washington, 98195
About this study
Official title: Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)
The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.
Read the detailed description
Patients will undergo an intake evaluation followed by a detailed ultrasound examination to rule out the presence of congenital anomalies and to assess the hemodynamic status of the fetuses and any pre-existing cerebral damage. The following data will be collected, as is identical to the standard of care in evaluating monochorionic twins
Maternal
- Age
- Gravidity and parity
- BMI
- Race/ethnicity
- Gestational age
- The presence of any symptoms
- Cervical length
Fetal
- Estimated fetal weight
- Detailed anatomy
- Doppler evaluation of umbilical cord, ductus venosus and middle cerebral arteries
- Evaluation of the myocardial performance indices
- Amniotic fluid volume
- Placental position
- Cord insertions
Patients will then be counseled about the risks and benefits of the procedure and will be asked to sign an informed consent.
The procedure will be performed under a spinal or local anesthesia at the discretion of the anesthesiologist and surgeon based upon placental position, maternal hemodynamic stability and maternal anxiety and ability to cooperate. Ultrasound guidance will help to select an appropriate incisional site. Under ultrasound guidance, a 2 mm skin incision will be made and a 10 French Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. An amniotic fluid sample will be obtained and sent for microbiological studies. A small aliquot of fluid will also be set aside for future institutional review board approved studies (see detail regarding banking below).
The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope. The Laser used is a Dornier Diode laser using a power of 30-40 Watts. At the conclusion of the anastomotic ablation, an ablation line will be created across the vascular equator, effectively dichorionizing the placenta. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be documented at the beginning and end of the procedure. An amniodrainage of the larger sac will be performed at the conclusion of the procedure to leave the amniotic fluid volume of that sac at a normal level.
- Being tested
- Fetoscopic laser ablation
- Keywords
- Twin, Monochorionic, Fetoscopy, Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic laser ablationProcedure or surgery
Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity.
The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with TTTS | Pregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome Receives: Procedure: Fetoscopic laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival to discharge from the nursery of affected babies
Measured: Immediately after the surgery to discharge from the hospital after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2031 (estimated)
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 as Antepartum ConditionStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Walker, Seattle Children's Hospital
- Investigators
- Martin P Walker, MD, Principal investigator, Seattle Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008744
- Sponsor's protocol ID
- 00003168
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)
- ClinicalTrials.gov ID
- NCT05008744
- Acronym / sponsor ID
- 00003168
- Keywords
- Twin, Monochorionic, Fetoscopy, Laser
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 17 Aug 2021 (actual)
- 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 purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.
Detailed description
Patients will undergo an intake evaluation followed by a detailed ultrasound examination to rule out the presence of congenital anomalies and to assess the hemodynamic status of the fetuses and any pre-existing cerebral damage. The following data will be collected, as is identical to the standard of care in evaluating monochorionic twins
Maternal
- Age
- Gravidity and parity
- BMI
- Race/ethnicity
- Gestational age
- The presence of any symptoms
- Cervical length
Fetal
- Estimated fetal weight
- Detailed anatomy
- Doppler evaluation of umbilical cord, ductus venosus and middle cerebral arteries
- Evaluation of the myocardial performance indices
- Amniotic fluid volume
- Placental position
- Cord insertions
Patients will then be counseled about the risks and benefits of the procedure and will be asked to sign an informed consent.
The procedure will be performed under a spinal or local anesthesia at the discretion of the anesthesiologist and surgeon based upon placental position, maternal hemodynamic stability and maternal anxiety and ability to cooperate. Ultrasound guidance will help to select an appropriate incisional site. Under ultrasound guidance, a 2 mm skin incision will be made and a 10 French Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. An amniotic fluid sample will be obtained and sent for microbiological studies. A small aliquot of fluid will also be set aside for future institutional review board approved studies (see detail regarding banking below).
The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope. The Laser used is a Dornier Diode laser using a power of 30-40 Watts. At the conclusion of the anastomotic ablation, an ablation line will be created across the vascular equator, effectively dichorionizing the placenta. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be documented at the beginning and end of the procedure. An amniodrainage of the larger sac will be performed at the conclusion of the procedure to leave the amniotic fluid volume of that sac at a normal level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with TTTS | – | Procedure: Fetoscopic laser ablationPregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant persons presenting with a diagnosis of twin to twin transfusion syndrome
Key inclusion criteria (5 listed)
- Single placenta (Monochorionic)
- Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
- Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
- Prominent bladder in the recipient/ non-filling bladder in the donor
- Thin dividing membrane
Key exclusion criteria (5 listed)
- Patients unwilling to participate in the study or to be followed up
- Presence of major congenital anomalies incompatible with survival
- Active pre-term labor Ruptured membranes
- Chorioamnionitis
- Vaginal bleeding
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 laser ablationUnder ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope. | Procedure or surgery | Patients presenting with TTTS |
Primary outcome
Survival
Time frame: Immediately after the surgery to discharge from the hospital after delivery
Survival to discharge from the nursery of affected babies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No. No sharing planned
Related trials for Twin to Twin Transfusion as Antepartum Condition
RecruitingObservational study
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition
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.
Martin P Walker, MD principal investigator
Seattle Childrens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin to Twin Transfusion as Antepartum Condition and Monochorionic Diamniotic Placenta, run by Seattle Children's Hospital at 2 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin P Walker, MD (206-987-3539 ext. 73539, martin.walker@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Immediately after the surgery to discharge from the hospital after delivery). 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 19 Apr 2024.