Twin Anemia Polycythemia Sequence Clinical Trial
Official title:
The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia-Polycythemia Sequence - a Multicenter Open-Label Randomized Controlled Trial
This multicenter open-label randomized controlled trial is set up to evaluate the effect of fetoscopic laser surgery on the gestational age at birth for monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence. Half op the patients will be treated with fetoscopic laser surgery, while the other half will be managed with standard treatment. The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
| Status | Recruiting |
| Enrollment | 44 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | April 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Monochorionic twin pregnancy complicated by either spontaneous or post-laser twin anemia polycythemia sequence (TAPS), stage = 2, diagnosed between 20+0 and till 28+0 weeks of gestation - Women aged 18 years or more, who are able to consent. - Written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees. Exclusion Criteria: - TAPS stage 1 - TAPS stage= 2, diagnosed within 1 week after laser surgery for twin-twin transfusion syndrome (TTTS) (a large inter-twin middle cerebral artery peak systolic velocity difference within a week after laser for TTTS is likely to related to hemodynamic reequilibration, and is usually not based on TAPS) - Triplet pregnancies, or higher order multiple pregnancies - TAPS cases that already underwent an intrauterine treatment (with the exception of laser surgery for TTTS in post-laser TAPS cases) - Congenital abnormalities (including severe cerebral injury) in one or both twins |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Vittore Buzzi Children's Hospital | Milan | Lombardy |
| Netherlands | Leiden University Medical Center | Leiden | South-Holland |
| Spain | Vall d'Hebron University Hospital | Barcelona | |
| Sweden | Karolinska University Hospital | Stockholm | Södermanland |
| United States | Yale University | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Leiden University Medical Center |
United States, Italy, Netherlands, Spain, Sweden,
Lopriore E, Middeldorp JM, Oepkes D, Kanhai HH, Walther FJ, Vandenbussche FP. Twin anemia-polycythemia sequence in two monochorionic twin pairs without oligo-polyhydramnios sequence. Placenta. 2007 Jan;28(1):47-51. Epub 2006 Mar 3. — View Citation
Robyr R, Lewi L, Salomon LJ, Yamamoto M, Bernard JP, Deprest J, Ville Y. Prevalence and management of late fetal complications following successful selective laser coagulation of chorionic plate anastomoses in twin-to-twin transfusion syndrome. Am J Obstet Gynecol. 2006 Mar;194(3):796-803. — View Citation
Sananès N, Veujoz M, Severac F, Barthoulot M, Meyer N, Weingertner AS, Kohler M, Guerra F, Gaudineau A, Nisand I, Favre R. Evaluation of the Utility of in utero Treatment of Twin Anemia-Polycythemia Sequence. Fetal Diagn Ther. 2015;38(3):170-8. doi: 10.1159/000380822. Epub 2015 Mar 17. — View Citation
Slaghekke F, Favre R, Peeters SH, Middeldorp JM, Weingertner AS, van Zwet EW, Klumper FJ, Oepkes D, Lopriore E. Laser surgery as a management option for twin anemia-polycythemia sequence. Ultrasound Obstet Gynecol. 2014 Sep;44(3):304-10. doi: 10.1002/uog.13382. Epub 2014 Aug 4. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gestational Age at Birth | Gestational age: completed weeks + additional days since the first day of the last menstruational period of the mother. | 2 weeks after expected date of birth | |
| Secondary | Number of patients with perinatal mortality | Perinatal mortality is defined as fetal death or neonatal death (demise of a liveborn child within 28 days after birth) | 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth | |
| Secondary | Number of patients with severe neonatal morbidity | Severe neonatal morbidity is defined as the presence of at least one of the following: Respiratory distress syndrome requiring surfactant or mechanical ventilation Proven early onset neonatal sepsis with positive blood cultures within 72 hours postpartum Retinopathy of prematurity stage 3 or higher Necrotizing enterocolitis stage 2 or higher Patent ductus arteriosus requiring medical therapy or surgical closure Severe cerebral injury (defined as 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) |
42 days (28 days neonatal period+2 weeks postdates) after expected date of birth | |
| Secondary | Number of patients with hematological complications | Hematological complications are defined as the presence of at least one of the following: Anemia in donor requiring a blood transfusion within 24 hours after birth Polycythemia in recipient requiring a partial exchange transfusion within 24 hours after birth necrotic skin injury limb ischemia platelet count < 150,000/microL albumin levels < 20 g/L protein levels < 40 g/L |
2 weeks after expected date of birth | |
| Secondary | Number of patients with procedure-related complications | Procedure-related complications are defined as at least one of the following: amniotic band syndrome iatrogenic monoamnionicity Preterm premature rupture of the membranes Placental abruption clinical chorioamnionitis histological chorioamnionitis and/or funisitis |
2 weeks after expected date of birth | |
| Secondary | Number of patient with mild neurodevelopmental impairment | Mild neurodevelopmental impairment is defined as at least one of the following: cerebral palsy (spastic bilateral, spastic unilateral, or mixed) Impaired cognitive or motor development defined as Score < 85 (1 standard deviation (SD) below the mean) as assessed by Bayley Scales of Infant and Toddler Development version 3 (BSID-III) Impaired functioning in communication, fine and gross motor, problem solving, personal and social functioning defined as Score > 1 SD below the mean as assessed by Ages and Stages Questionnaire version 3 (ASQ-III) severe visual loss (blind or partially sighted) severe hearing loss (needing hearing aids) |
2 years after expected date of birth | |
| Secondary | Number of patients with severe neurodevelopmental impairment | Severe neurodevelopmental impairment is defined as at least one of the following: cerebral palsy defined as a gross motor function classification system (CMFCS) grade > 1 Impaired cognitive or motor development defined as a score < 70 (2 SD below the mean) as assessed by the Bayley Scales of Infant and Toddler Development version 3 (BSID-III) Impaired functioning in communication, fine and gross motor, problem solving, personal and social functioning defined as a score > 2 SD below the mean as assessed by Ages and Stages Questionnaire version 3 (ASQ-III) Bilateral blindness defined as visual acuity of less than 3/60 in the better eye Bilateral deafness defined as severe or profound hearing loss in both ears (severe hearing loss: a person can only hear sounds > 70-89 decibel , profound hearing loss: a person can only hear sounds > 90 decibel |
2 years after expected date of birth | |
| Secondary | Number of patients with behavioral problems | Behavioral problems are defined as a T-score = 64 for one of the following broad band scales: total problem score, Internalizing problems (anxious/depressed, withdrawn, somatic complaints), Externalizing problems (rule-breaking, aggressive behavior) as measured with the Child Behaviour Checklist 1.5-5 years | 2 years after expected date of birth |