Twin Reversal Arterial Perfusion SyndromePhase 4TRAPISTNCT02621645
TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
A Phase 4 study testing Early selective reduction of TRAP mass, Late selective reduction of TRAP mass and Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle in people with Twin Reversal Arterial Perfusion Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in 11 countries.
Trial summary
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin Reversal Arterial Perfusion Syndrome
- What is being tested?
- Early selective reduction of TRAP mass, Late selective reduction of TRAP mass and Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 14 sitesin 11 countries
- Study dates
- May 2016to Jun 2025
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TRAP sequence in a monochorionic diamniotic twin pregnancy diagnosed between 11.6 and 13.6 weeks, as determined by the crown-rump length of the pump twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment
- Women aged 18 years or more, who are able to consent
- Anatomically normal pump twin
- Provide written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees
Who cannot join
- Contraindication for an intervention due to a severe maternal medical condition or threatening miscarriage
- Inaccessibility of the acardiac twin due to a retroverted uterus, severe maternal obesity, uterine fibroids, bowel or placental superposition
- A major anomaly in the pump twin, requiring surgery or leading to infant death or severe handicap
- Spontaneous arrest of the reverse flow and/or pump twin demise at diagnosis
Trial locations and contacts
14 sites in 11 countries.
14 sites in 11 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Women's Hospital
Birmingham
Mark Kilby
- Recruiting
King's College
London
Sarah Bower
- Recruiting
St. George's Hospital, University of London (UK sponsor)
London
Asma Khalil
Sarah Davies
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan
Nicola Persico
- Recruiting
Ospedale dei Bambini Vittore Buzzi
Milan
Mariano Lanna
United States1 site, 1 recruiting
- Recruiting
Children's Memorial Hermann Hospital
Houston, Texas
Anthony Johnson
Noemi Boring
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Graz
Philipp Klaritsch
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven
Liesbeth Lewi
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto
Tim Van Mieghem
Greg Ryan
France1 site, 1 recruiting
- Recruiting
Centre Médico-Chirurgical et Obstétrical
Schiltigheim
Romain Favre
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Christian Bamberg
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel Litwinsky
Yoav Yinon
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
Dick Oepkes
Monique Haak
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Carlota Rodo
About this study
Official title: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.
Read the detailed description
The investigators propose to conduct a multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 11.6 and 13.6 weeks (1:1) to an early or late intervention group, using a web-based application (www.sealedenvelope.com) with a computer-generated list with random permuted blocks of sizes 2 or 4, stratified by gestational age at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention-to-treat. Outcome will be adjudicated blinded to group allocation.
All interventions will be done under local anaesthesia and/or conscious sedation in sterile conditions by an experienced operator. They must be performed within 1 week after randomisation and at the latest at 14.0 weeks in the early group and 19.0 weeks in the late group. In the early group, only intrafetal coagulation will be used. Intrafetal ablation will be performed under ultrasound guidance using an 18-gauge (1.27 mm) to 20-gauge (0.91 mm) needle with a free-hand technique. The needle is introduced into the pelvis/abdomen of the TRAP mass close to the intra-abdominal portion of the feeding vessel, while avoiding puncture of the placenta and pump twin sac. The procedure is considered successful when there is complete cessation of reverse flow into the TRAP mass on intraoperative color-flow mapping.
In the late intervention/control group either intrafetal coagulation or fetoscopic laser coagulation will be performed of the cord and/or anastomosing vessels, unless the flow has stopped spontaneously or demise of the pump twin has occurred in the meantime. Intrafetal coagulation is done as described above by using a 17-gauge (1.47 mm) to 20-gauge needle. Alternatively, fetoscopic laser coagulation of the cord or anastomosing vessels can be performed through a 17-gauge to 7 French trocar with 1-1,3 mm fetoscope and 400 μm laser fiber. The rationale not to standardize the technique in the late intervention group is that several techniques have been reported for treatment after 16 weeks without any significant differences in outcome. Also, it is usual for the surgeon to adapt the technique to the requirements of each individual case, e.g. for a posterior placenta, the surgeon may prefer fetoscopic rather than intrafetal coagulation. Not restricting the technique to only 1 option will therefore more truly represent current practice and increase the generalizability of the trial's findings.
Patients will be discharged the same day or 1 day after the procedure. Management and follow-up will be similar for the study and the control or current practice group. A follow-up scan is usually performed 1 week after the intervention to check for fetal well-being and exclude anemia. A detailed ultrasound scan will be arranged in a fetal medicine center at 20 and 30 weeks to assess the heart and brain anatomy. Some centers may offer an MRI scan at around 30 weeks as part of the protocol for monochorionic twin pregnancies that underwent an intrauterine intervention. Antenatal, peripartum and postnatal care of the mother will be similar to that of a singleton pregnancy and at the discretion of the referring physician. Intrauterine intervention for TRAP sequence is not an indication for cesarean or elective preterm birth.
- Being tested
- Early selective reduction of TRAP mass, Late selective reduction of TRAP mass, Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle, Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle, Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber
- Keywords
- monochorionic, TRAP, acardiac twin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early selective reduction of TRAP massProcedure or surgery
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
Late selective reduction of TRAP massProcedure or surgery
Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction.
Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needleDevice
Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needleDevice
Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiberDevice
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Intervention between 12.0 and 14.0 weeks. Early selective reduction of TRAP mass. Receives: Procedure: Early selective reduction of TRAP mass; Device: Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle |
| Late intervention | Active comparator | Intervention between 16.0 and 19.0 weeks. Late selective reduction of TRAP mass. This is the standard timing of the intervention. One of two possible techniques for late reduction is chosen by the treating physician. Receives: Procedure: Late selective reduction of TRAP mass; Device: Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle; Device: Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with neonatal survival and birth at or after 34.0 weeks of the pump twin
Measured: 2 weeks after expected date of birth
Secondary outcomes (16)
Number of patients with need for re-intervention
This means any kind of fetal intervention, such as repeated intrafetal coagulation, intra-uterine transfusion cord-occlusion...
Measured: 2 weeks after expected date of birth
Number of patients with maternal morbidity
Maternal morbidity is defined as presence of one or more of the following events:
- Need for transfusion for hemorrhage
- Abruption
- Chorioamnionitis as defined on pathology
- Sepsis
- Bowel perforation
- Other serious maternal morbidity requiring admission to ICU
Measured: 2 weeks after expected date of birth
Number of patients with miscarriage
Number of patients with miscarriage before 24 weeks
Measured: 2 weeks after expected date of birth
Number of patients with preterm prelabor rupture of membranes (PPROM)
Number of patients with rupture of membranes before onset of labor and before 37 weeks
Measured: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 28 weeks
Number of patients delivering before 28 weeks
Measured: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 32 weeks
Number of patients delivering before 32 weeks
Measured: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 37 weeks
Number of patients delivering before 37 weeks
Measured: 2 weeks after expected date of birth
Time from randomization to delivery
Number of weeks between randomization and the time of delivery
Measured: 2 weeks after expected date of birth
Time from randomization to PPROM
Number of weeks between randomization and rupture of membranes in patients with PPROM
Measured: 2 weeks after expected date of birth
Birth weight in grams
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with stillbirth
Stillbirth refers to all patients with antepartum or intrapartum demise of the fetus
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with neonatal death
Demise of a live-born child within the first 28 days of life
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with severe neonatal morbidity
Severe neonatal morbidity is defined as the presence of at least one of the following:
- chronic lung disease (defined as oxygen dependency at 36 weeks gestational age)
- patent ductus arteriosus needing medical therapy or surgical closure
- necrotizing enterocolitis stage 2 or higher
- retinopathy of prematurity stage 3 or higher
- ischemic limb injury
- amniotic band syndrome
- severe cerebral injury (includes at least one of the following: intraventricular hemorrhage grade 3 or higher, cystic periventricular leukomalacia grade 2 or higher, ventricular dilatation greater than the 97th centile, porencephalic or parenchymal cysts or other severe cerebral lesions).
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
High volume vs low volume centers of neonatal survival and birth at or after 34.0 weeks of the pump twin and maternal morbidity parameters
Measured: 2 weeks after expected date of birth
Number of patients with intact survival rate
Intact survival rate defined as the number of surviving infants with normal development at two years corrected for prematurity as assessed by the ASQ® score for infant development (Ages \& Stages Questionnaire). A score of more than 2 standard deviations below the mean score for term-born children will be considered abnormal.
Measured: 2 years after expected date of birth
Number of patients with normal Bayley III score
Number of patients with normal Bayley III score at two years of age corrected for prematurity
Measured: 2 years after expected date of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Twin Reversal Arterial Perfusion SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- St. George's Hospital, University of London (UK sponsor), Leiden University Medical Center, Ospedalo Maggiore Policlinico di Milano, Italy, Hospital Universitari Vall d'hebron Barcelona, Spain, Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France, Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria, Ospedale dei Bambini "Vittore Buzzi" Milano, Italy, Birmingham Women's Hospital, UK, Sheba Medical Center, Children's Memorial Hermann Hospital Houston Texas, USA, Universitätsklinikum Hamburg-Eppendorf, Mount Sinai Hospital, Canada, University of Pittsburgh, University Hospital Innsbruck, Austria, Spedali Civili, University of Brescia, Italy
- Responsible party
- Sponsor
- Investigators
- Liesbeth Lewi, MD PhD, Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621645
- Sponsor's protocol ID
- S58224
- Acronym
- TRAPIST
- Status last verified
- Jul 2024
- First submitted
- 12 Nov 2015
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moore TR, Gale S, Benirschke K. Perinatal outcome of forty-nine pregnancies complicated by acardiac twinning. Am J Obstet Gynecol. 1990 Sep;163(3):907-12. doi: 10.1016/0002-9378(90)91094-s.
PubMed 2206078Pagani G, D'Antonio F, Khalil A, Papageorghiou A, Bhide A, Thilaganathan B. Intrafetal laser treatment for twin reversed arterial perfusion sequence: cohort study and meta-analysis. Ultrasound Obstet Gynecol. 2013 Jul;42(1):6-14. doi: 10.1002/uog.12495.
PubMed 23640771Hecher K, Lewi L, Gratacos E, Huber A, Ville Y, Deprest J. Twin reversed arterial perfusion: fetoscopic laser coagulation of placental anastomoses or the umbilical cord. Ultrasound Obstet Gynecol. 2006 Oct;28(5):688-91. doi: 10.1002/uog.3816.
PubMed 16958150Chaveeva P, Poon LC, Sotiriadis A, Kosinski P, Nicolaides KH. Optimal method and timing of intrauterine intervention in twin reversed arterial perfusion sequence: case study and meta-analysis. Fetal Diagn Ther. 2014;35(4):267-79. doi: 10.1159/000358593. Epub 2014 Apr 16.
PubMed 24751835Lewi L, Valencia C, Gonzalez E, Deprest J, Nicolaides KH. The outcome of twin reversed arterial perfusion sequence diagnosed in the first trimester. Am J Obstet Gynecol. 2010 Sep;203(3):213.e1-4. doi: 10.1016/j.ajog.2010.04.018. Epub 2010 Jun 3.
PubMed 20522408O'Donoghue K, Barigye O, Pasquini L, Chappell L, Wimalasundera RC, Fisk NM. Interstitial laser therapy for fetal reduction in monochorionic multiple pregnancy: loss rate and association with aplasia cutis congenita. Prenat Diagn. 2008 Jun;28(6):535-43. doi: 10.1002/pd.2025.
PubMed 18509857Scheier M, Molina FS. Outcome of twin reversed arterial perfusion sequence following treatment with interstitial laser: a retrospective study. Fetal Diagn Ther. 2012;31(1):35-41. doi: 10.1159/000334156. Epub 2011 Dec 23.
PubMed 22204966Berg C, Holst D, Mallmann MR, Gottschalk I, Gembruch U, Geipel A. Early vs late intervention in twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2014 Jan;43(1):60-4. doi: 10.1002/uog.12578.
PubMed 23908075Jelin E, Hirose S, Rand L, Curran P, Feldstein V, Guevara-Gallardo S, Jelin A, Gonzales K, Goldstein R, Lee H. Perinatal outcome of conservative management versus fetal intervention for twin reversed arterial perfusion sequence with a small acardiac twin. Fetal Diagn Ther. 2010;27(3):138-41. doi: 10.1159/000295176. Epub 2010 Mar 9.
PubMed 20215730Lewi L, Gratacos E, Ortibus E, Van Schoubroeck D, Carreras E, Higueras T, Perapoch J, Deprest J. Pregnancy and infant outcome of 80 consecutive cord coagulations in complicated monochorionic multiple pregnancies. Am J Obstet Gynecol. 2006 Mar;194(3):782-9. doi: 10.1016/j.ajog.2005.09.013.
PubMed 16522413Kerstjens JM, Nijhuis A, Hulzebos CV, van Imhoff DE, van Wassenaer-Leemhuis AG, van Haastert IC, Lopriore E, Katgert T, Swarte RM, van Lingen RA, Mulder TL, Laarman CR, Steiner K, Dijk PH. The Ages and Stages Questionnaire and Neurodevelopmental Impairment in Two-Year-Old Preterm-Born Children. PLoS One. 2015 Jul 20;10(7):e0133087. doi: 10.1371/journal.pone.0133087. eCollection 2015.
PubMed 26193474
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy
- ClinicalTrials.gov ID
- NCT02621645
- Acronym / sponsor ID
- TRAPIST / S58224
- Keywords
- monochorionic, TRAP, acardiac twin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- St. George's Hospital, University of London (UK sponsor), Leiden University Medical Center, Ospedalo Maggiore Policlinico di Milano, Italy, Hospital Universitari Vall d'hebron Barcelona, Spain, Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France, Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria, Ospedale dei Bambini "Vittore Buzzi" Milano, Italy, Birmingham Women's Hospital, UK, Sheba Medical Center, Children's Memorial Hermann Hospital Houston Texas, USA, Universitätsklinikum Hamburg-Eppendorf, Mount Sinai Hospital, Canada, University of Pittsburgh, University Hospital Innsbruck, Austria, Spedali Civili, University of Brescia, Italy
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Dec 2015 (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.
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.
Detailed description
The investigators propose to conduct a multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 11.6 and 13.6 weeks (1:1) to an early or late intervention group, using a web-based application (www.sealedenvelope.com) with a computer-generated list with random permuted blocks of sizes 2 or 4, stratified by gestational age at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention-to-treat. Outcome will be adjudicated blinded to group allocation.
All interventions will be done under local anaesthesia and/or conscious sedation in sterile conditions by an experienced operator. They must be performed within 1 week after randomisation and at the latest at 14.0 weeks in the early group and 19.0 weeks in the late group. In the early group, only intrafetal coagulation will be used. Intrafetal ablation will be performed under ultrasound guidance using an 18-gauge (1.27 mm) to 20-gauge (0.91 mm) needle with a free-hand technique. The needle is introduced into the pelvis/abdomen of the TRAP mass close to the intra-abdominal portion of the feeding vessel, while avoiding puncture of the placenta and pump twin sac. The procedure is considered successful when there is complete cessation of reverse flow into the TRAP mass on intraoperative color-flow mapping.
In the late intervention/control group either intrafetal coagulation or fetoscopic laser coagulation will be performed of the cord and/or anastomosing vessels, unless the flow has stopped spontaneously or demise of the pump twin has occurred in the meantime. Intrafetal coagulation is done as described above by using a 17-gauge (1.47 mm) to 20-gauge needle. Alternatively, fetoscopic laser coagulation of the cord or anastomosing vessels can be performed through a 17-gauge to 7 French trocar with 1-1,3 mm fetoscope and 400 μm laser fiber. The rationale not to standardize the technique in the late intervention group is that several techniques have been reported for treatment after 16 weeks without any significant differences in outcome. Also, it is usual for the surgeon to adapt the technique to the requirements of each individual case, e.g. for a posterior placenta, the surgeon may prefer fetoscopic rather than intrafetal coagulation. Not restricting the technique to only 1 option will therefore more truly represent current practice and increase the generalizability of the trial's findings.
Patients will be discharged the same day or 1 day after the procedure. Management and follow-up will be similar for the study and the control or current practice group. A follow-up scan is usually performed 1 week after the intervention to check for fetal well-being and exclude anemia. A detailed ultrasound scan will be arranged in a fetal medicine center at 20 and 30 weeks to assess the heart and brain anatomy. Some centers may offer an MRI scan at around 30 weeks as part of the protocol for monochorionic twin pregnancies that underwent an intrauterine intervention. Antenatal, peripartum and postnatal care of the mother will be similar to that of a singleton pregnancy and at the discretion of the referring physician. Intrauterine intervention for TRAP sequence is not an indication for cesarean or elective preterm birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Procedure: Early selective reduction of TRAP mass, Device: Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needleIntervention between 12.0 and 14.0 weeks. Early selective reduction of TRAP mass. |
| Late intervention | Active comparator | Procedure: Late selective reduction of TRAP mass, Device: Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle, Device: Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiberIntervention between 16.0 and 19.0 weeks. Late selective reduction of TRAP mass. This is the standard timing of the intervention. One of two possible techniques for late reduction is chosen by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- TRAP sequence in a monochorionic diamniotic twin pregnancy diagnosed between 11.6 and 13.6 weeks, as determined by the crown-rump length of the pump twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment
- Women aged 18 years or more, who are able to consent
- Anatomically normal pump twin
- Provide written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees
Key exclusion criteria (4 listed)
- Contraindication for an intervention due to a severe maternal medical condition or threatening miscarriage
- Inaccessibility of the acardiac twin due to a retroverted uterus, severe maternal obesity, uterine fibroids, bowel or placental superposition
- A major anomaly in the pump twin, requiring surgery or leading to infant death or severe handicap
- Spontaneous arrest of the reverse flow and/or pump twin demise at diagnosis
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 |
|---|---|---|
| Early selective reduction of TRAP massUltrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle | Procedure or surgery | Early intervention |
| Late selective reduction of TRAP massUltrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction. | Procedure or surgery | Late intervention |
| Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle | Device | Early intervention |
| Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle | Device | Late intervention |
| Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber | Device | Late intervention |
Primary outcome
Number of patients with neonatal survival and birth at or after 34.0 weeks of the pump twin
Time frame: 2 weeks after expected date of birth
16 secondary outcomes
Number of patients with need for re-intervention
Time frame: 2 weeks after expected date of birth
Number of patients with maternal morbidity
Time frame: 2 weeks after expected date of birth
Number of patients with miscarriage
Time frame: 2 weeks after expected date of birth
Number of patients with preterm prelabor rupture of membranes (PPROM)
Time frame: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 28 weeks
Time frame: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 32 weeks
Time frame: 2 weeks after expected date of birth
Number of patients with preterm birth prior to 37 weeks
Time frame: 2 weeks after expected date of birth
Time from randomization to delivery
Time frame: 2 weeks after expected date of birth
Time from randomization to PPROM
Time frame: 2 weeks after expected date of birth
Birth weight in grams
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with stillbirth
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with neonatal death
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with severe neonatal morbidity
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
High volume vs low volume centers of neonatal survival and birth at or after 34.0 weeks of the pump twin and maternal morbidity parameters
Time frame: 2 weeks after expected date of birth
Number of patients with intact survival rate
Time frame: 2 years after expected date of birth
Number of patients with normal Bayley III score
Time frame: 2 years after expected date of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 2206078Moore TR, Gale S, Benirschke K. Perinatal outcome of forty-nine pregnancies complicated by acardiac twinning. Am J Obstet Gynecol. 1990 Sep;163(3):907-12. doi: 10.1016/0002-9378(90)91094-s.
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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.
Liesbeth Lewi, MD PhD study chair
UZ Leuven
14 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early selective reduction of TRAP mass, Late selective reduction of TRAP mass and Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle in people with Twin Reversal Arterial Perfusion Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in 11 countries.
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 4 inclusion and 4 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Italy, United States, Austria, Belgium and 6 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Isabel Couck, MD (+32 16 342294, isabel.couck@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with neonatal survival and birth at or after 34.0 weeks of the pump twin (time frame: 2 weeks after expected date of birth). 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 NCT02621645, which also lists 11 linked publications.
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 10 Jul 2024.