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NCT01177553 · ClinicalTrials.gov registry record · NA
Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
A NA study, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01177553 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 5 participants.
The verdict
NCT01177553, a NA study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe neurologic handicap (up to 30% risk) of the other twin. These complications result from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through placental vascular communications. Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are mediated through placental vascular anastomoses, we have proposed obliterating such anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV communications are identified on the surface of the placenta by noting that the terminal end of the artery of one of the fetuses does not have a corresponding returning vein to the same fetus. We have speculated that the separation of the circulations may be of benefit in monochorionic twins affected by SIUGR by preventing the adverse effects that may result from the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical trial the outcome of SIUGR managed either expectantly or with SLPCV. Study procedures will begin with confirmation of the diagnosis and screening criteria at the Qualified Clinical Center. The patient will sign the appropriate consents and then be randomized to her treatment group. Enrollment data will be submitted to the research coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa General Hospital or qualified laser center. They may return to the referring center for follow-up.
Interventions
- PROCEDURE selective laser photocoagulation of communicating vessels
- DEVICE Expected Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01177553
The ClinicalTrials.gov registry entry for NCT01177553 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which selective laser photocoagulation of communicating vessels is the first listed.
NCT01177553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01177553 about?
NCT01177553 is a clinical study titled "Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery". Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and...
What is the current status of trial NCT01177553?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2007-05. Estimated completion is 2009-02.
What interventions are being tested in trial NCT01177553?
The interventions under investigation include: selective laser photocoagulation of communicating vessels (PROCEDURE), Expected Management (DEVICE).
Who is sponsoring clinical trial NCT01177553?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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