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Fetoscopic Laser Surgery for TAPS
N/A
Waitlist Available
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
Must not have
TAPS stage≥ 2, diagnosed within 1 week after laser surgery for twin-twin transfusion syndrome (TTTS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am pregnant with twins, have TAPS stage 2 or higher, and was diagnosed between 20 and 28 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My TAPS stage is 2 or higher, diagnosed within a week after my TTTS laser surgery.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gestational Age at Birth
Secondary study objectives
Number of patient with mild neurodevelopmental impairment
Number of patients with behavioral problems
Number of patients with hematological complications
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Leiden University Medical CenterLead Sponsor
557 Previous Clinical Trials
607,121 Total Patients Enrolled
Dick Oepkes, MD PhDPrincipal InvestigatorLeiden University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for TAPS, but not laser surgery for TTTS.My TAPS stage is 2 or higher, diagnosed within a week after my TTTS laser surgery.I am a woman aged 18 or older and can give consent.I am pregnant with twins, have TAPS stage 2 or higher, and was diagnosed between 20 and 28 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Treatment
- Group 2: Fetoscopic Laser Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.