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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01177553
First received: August 5, 2010
Last updated: February 20, 2013
Last verified: February 2013
Results First Received: September 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intrauterine Growth Retardation
Interventions: Procedure: selective laser photocoagulation of communicating vessels
Device: Expected Management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Surgery Group

Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.

Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures.

Expectant Management Group Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.

Participant Flow:   Overall Study
    Surgery Group     Expectant Management Group  
STARTED     3     2  
COMPLETED     2 [1]   2 [1]
NOT COMPLETED     1     0  
babies not yet 6 months of age                 1                 0  
[1] data as of March 2009



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Surgery Group

Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.

Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures.

Expectant Management Group Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient’s perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
Total Total of all reporting groups

Baseline Measures
    Surgery Group     Expectant Management Group     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     2     5  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     2     5  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  



  Outcome Measures

1.  Primary:   Survival   [ Time Frame: 6 months ]

2.  Secondary:   Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Research Coordinator
Organization: University of South Florida
phone: 813-259-8680
e-mail: obgynclinicalresearch@health.usf.edu


Publications:
Hamilton EF, Platt RW, Morin L, Usher R, Kramer M. How small is too small in a twin pregnancy? Am J Obstet Gynecol 1998;179:682-5.


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01177553     History of Changes
Other Study ID Numbers: IRB#105690
Study First Received: August 5, 2010
Results First Received: September 21, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration