← Back to Search

Fetoscopic Laser Surgery for TAPS

N/A

Recruiting

Led By Dick Oepkes, MD PhD

Research Sponsored by Leiden University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing whether fetoscopic laser surgery can improve neonatal outcomes by prolonging pregnancy in monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence.

Who is the study for?

This trial is for women over 18 with monochorionic twin pregnancies experiencing twin anemia-polycythemia sequence (TAPS) at stage ≥2, diagnosed between the 20th and 28th weeks of gestation. It's not for those with triplet or higher order pregnancies, TAPS stage≥2 just after TTTS surgery, TAPS stage 1, or twins who've had other intrauterine treatments.Check my eligibility

What is being tested?

The study compares fetoscopic laser surgery to standard treatment in managing TAPS in monochorionic twins. The goal is to see if this surgery can extend pregnancy and improve neonatal outcomes compared to standard care.See study design

What are the potential side effects?

While specific side effects are not listed here, fetoscopic laser surgery may include risks typical of surgical interventions such as bleeding, infection risk for mother and babies, premature birth, or potential harm to the twins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant with twins, have TAPS stage 2 or higher, and was diagnosed between 20 and 28 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gestational Age at Birth

Secondary outcome measures

Number of patient with mild neurodevelopmental impairment

Number of patients with behavioral problems

Number of patients with hematological complications

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard TreatmentExperimental Treatment1 Intervention

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

Group II: Fetoscopic Laser SurgeryExperimental Treatment1 Intervention

fetoscopic laser coagulation of the vascular anastomoses at the placental surface

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Leiden University Medical CenterLead Sponsor

529 Previous Clinical Trials

581,614 Total Patients Enrolled

Dick Oepkes, MD PhDPrincipal InvestigatorLeiden University Medical Center

Media Library

Fetoscopic Laser Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04432168 — N/A

Twin Anemia Polycythemia Sequence Research Study Groups: Standard Treatment, Fetoscopic Laser Surgery

Twin Anemia Polycythemia Sequence Clinical Trial 2023: Fetoscopic Laser Surgery Highlights & Side Effects. Trial Name: NCT04432168 — N/A

Fetoscopic Laser Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432168 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have registered for this investigation?

"Affirmative. Per the information on clinicaltrials.gov, this study is actively recruiting patients - having been first posted on April 30th 2019 and most recently updated June 11th 2020. 44 individuals need to be enlisted from a single medical centre for the trial to go ahead."

Answered by AI

Are recruitment efforts underway for this experiment?

"Affirmative. On clinicaltrials.gov, it is indicated that this medical study, which was first posted on April 30th 2019, is actively seeking participants. 44 individuals are required from a single location to form the trial's cohort."

Answered by AI

Is the minimum age criteria for this study more than two decades old?

"This trial is looking for suitable participants who are aged between 18 and 50 years old. For those younger than this, there are 93 studies available while 206 trials exist for patients older than 65."

Answered by AI

May I have the opportunity to join this experiment?

"The research team aims to recruit 44 anemic individuals aged 18-50. In addition, the study is particularly interested in female participants of legal age who are able to provide informed consent."

Answered by AI

Recent research and studies

Fetal Diagnosis and TherapyJournal

Evaluation of the Utility of in Utero Treatment of Twin Anemia-polycythemia Sequence

Sananès, Nicolas, Marine Veujoz, Francois Severac, Maël Barthoulot, Nicolas Meyer, Anne-Sophie Weingertner, Monique Kohler, et al.. 2015. “Evaluation of the Utility of in Utero Treatment of Twin Anemia-polycythemia Sequence”. Fetal Diagnosis and Therapy. S. Karger AG. doi:10.1159/000380822.

American Journal of Obstetrics and GynecologyJournal

Prevalence and Management of Late Fetal Complications Following Successful Selective Laser Coagulation of Chorionic Plate Anastomoses in Twin-to-twin Transfusion Syndrome

Robyr, Romaine, Liesbeth Lewi, Laurent J. Salomon, Masami Yamamoto, Jean-Pierre Bernard, Jan Deprest, and Yves Ville. 2006. “Prevalence and Management of Late Fetal Complications Following Successful Selective Laser Coagulation of Chorionic Plate Anastomoses in Twin-to-twin Transfusion Syndrome”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2005.08.069.

PlacentaJournal

Twin Anemia–polycythemia Sequence in Two Monochorionic Twin Pairs Without Oligo-polyhydramnios Sequence

Lopriore, E., J.M. Middeldorp, D. Oepkes, H.H. Kanhai, F.J. Walther, and F.P.H.A. Vandenbussche. 2007. “Twin Anemia–polycythemia Sequence in Two Monochorionic Twin Pairs Without Oligo-polyhydramnios Sequence”. Placenta. Elsevier BV. doi:10.1016/j.placenta.2006.01.010.

Ultrasound in Obstetrics & GynecologyJournal