The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence

NCT04432168 | Unknown DMC

• 1 other identifier: NL6442700018
• Study Type: interventional
• Target: 44
• Locations: 5 countries
• Sites: 5

Brief Summary

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.

Conditions

Twin Anemia Polycythemia Sequence

Keywords

Monochorionic Twins; Twin-Twin Transfusion Syndrome; Fetoscopic Laser Surgery; Intrauterine Transfusion; Partial Exchange Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of patients with perinatal mortality

  42 days (28 days neonatal period+2 weeks postdates) after expected date of birth

• Number of patients with severe neonatal morbidity

  42 days (28 days neonatal period+2 weeks postdates) after expected date of birth

• Number of patients with hematological complications

  2 weeks after expected date of birth

• Number of patients with procedure-related complications

  2 weeks after expected date of birth

• Number of patient with mild neurodevelopmental impairment

  2 years after expected date of birth

Study Arms (2)

Fetoscopic Laser Surgery

EXPERIMENTAL

fetoscopic laser coagulation of the vascular anastomoses at the placental surface

Procedure: Fetoscopic Laser Surgery

Standard Treatment

OTHER

Expectant management, IUT (with or without PET), preterm delivery

Other: Standard Treatment

Interventions

Fetoscopic Laser Surgery PROCEDURE

Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.

Also known as: Fetoscopic Laser Coagulation, Laser therapy, Fetoscopic Laser Ablation

Fetoscopic Laser Surgery

Standard Treatment OTHER

In the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease. * Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week. * IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia. * PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia. * Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation.

Standard Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (5)

Yale University

New Haven, Connecticut, 208327, United States

NOT YET RECRUITING

Vittore Buzzi Children's Hospital

Milan, Lombardy, 20154, Italy

RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

Karolinska University Hospital

Stockholm, Södermanland County, 141 86, Sweden

NOT YET RECRUITING

Related Publications (4)

• 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. doi: 10.1016/j.placenta.2006.01.010. Epub 2006 Mar 3.

  PMID: 16516289 BACKGROUND

• 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. doi: 10.1016/j.ajog.2005.08.069.

  PMID: 16522415 BACKGROUND

• Sananes 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.

  PMID: 25790745 BACKGROUND

• 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.

  PMID: 24706478 BACKGROUND

MeSH Terms

Conditions

Fetofetal Transfusion

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dick Oepkes, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Femke Slaghekke, MD PhD

CONTACT

+31 71 52 97211; f.slaghekke@lumc.nl

Lisanne Tollenaar, BSc

CONTACT

+31653413875; l.s.a.tollenaar@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. D. Oepkes

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 16, 2020
• Study Start: April 30, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2024
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); SE (1); US (1); IT (1); ES (1)