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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. After delivery, outcome data will be sent to the research coordinator in Coordinating Center in Tampa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Group | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selective laser photocoagulation of communicating vessels | Procedure | Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. The use of these medications is safe in pregnancy in the doses and schedules outlined. Surgery will be performed under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. The patient will undergo either SLPCV or UCO depending on her choice. Patients will remain hospitalized for 24-48 hours. All subjects will be monitored during their hospital stay. Any unanticipated adverse events or serious adverse events will be reported to the IRB according to IRB reporting requirements. Prior to discharge from the hospital an investigator will perform a post-procedure ultrasound to assess fetal status |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben A Quintero, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States | ||
| University of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9840574 | Background | Lin CC, Santolaya-Forgas J. Current concepts of fetal growth restriction: part I. Causes, classification, and pathophysiology. Obstet Gynecol. 1998 Dec;92(6):1044-55. doi: 10.1016/s0029-7844(98)00328-7. | |
| 9610996 | Background | Ananth CV, Vintzileos AM, Shen-Schwarz S, Smulian JC, Lai YL. Standards of birth weight in twin gestations stratified by placental chorionicity. Obstet Gynecol. 1998 Jun;91(6):917-24. doi: 10.1016/s0029-7844(98)00052-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Expected Management | Device | 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. |
|
|
| Tampa |
| Florida |
| 33606 |
| United States |
| 9757971 | Background | Hamilton EF, Platt RW, Morin L, Usher R, Kramer M. How small is too small in a twin pregnancy? Am J Obstet Gynecol. 1998 Sep;179(3 Pt 1):682-5. doi: 10.1016/s0002-9378(98)70064-x. |
| 3764450 | Background | Dudley DK, D'Alton ME. Single fetal death in twin gestation. Semin Perinatol. 1986 Jan;10(1):65-72. No abstract available. |
| 2198920 | Background | Fusi L, Gordon H. Twin pregnancy complicated by single intrauterine death. Problems and outcome with conservative management. Br J Obstet Gynaecol. 1990 Jun;97(6):511-6. doi: 10.1111/j.1471-0528.1990.tb02521.x. |
| 10910594 | Background | Lin IJ, Chen CH, Wang TM, Fu LS, Chi CS. Infants of twin pregnancies with one twin demise in the uterus: a retrospective study. Acta Paediatr Taiwan. 1999 Mar-Apr;40(2):92-6. |
| 10668142 | Background | Axt R, Hippach M, Mink D, Hendrik HJ, Ertan AK, Schmidt W. Maternal and neonatal outcome in a monochorionic twin pregnancy complicated by single intrauterine demise. Clin Exp Obstet Gynecol. 1999;26(3-4):155-7. |
| 10078581 | Background | Petersen IR, Nyholm HC. Multiple pregnancies with single intrauterine demise. Description of twenty-eight pregnancies. Acta Obstet Gynecol Scand. 1999 Mar;78(3):202-6. |
| 2178843 | Background | Burke MS. Single fetal demise in twin gestation. Clin Obstet Gynecol. 1990 Mar;33(1):69-78. |
| 10732306 | Background | Saito K, Ohtsu Y, Amano K, Nishijima M. Perinatal outcome and management of single fetal death in twin pregnancy: a case series and review. J Perinat Med. 1999;27(6):473-7. doi: 10.1515/JPM.1999.063. |
| 10623986 | Background | Nicolini U, Poblete A. Single intrauterine death in monochorionic twin pregnancies. Ultrasound Obstet Gynecol. 1999 Nov;14(5):297-301. doi: 10.1046/j.1469-0705.1999.14050297.x. No abstract available. |
| 8008302 | Background | Kilby MD, Govind A, O'Brien PM. Outcome of twin pregnancies complicated by a single intrauterine death: a comparison with viable twin pregnancies. Obstet Gynecol. 1994 Jul;84(1):107-9. |
| 14749653 | Background | Adegbite AL, Castille S, Ward S, Bajoria R. Neuromorbidity in preterm twins in relation to chorionicity and discordant birth weight. Am J Obstet Gynecol. 2004 Jan;190(1):156-63. doi: 10.1016/j.ajog.2003.07.004. |
| 7996959 | Background | Karsdorp VH, van Vugt JM, van Geijn HP, Kostense PJ, Arduini D, Montenegro N, Todros T. Clinical significance of absent or reversed end diastolic velocity waveforms in umbilical artery. Lancet. 1994 Dec 17;344(8938):1664-8. doi: 10.1016/s0140-6736(94)90457-x. |
| 8141204 | Background | Valcamonico A, Danti L, Frusca T, Soregaroli M, Zucca S, Abrami F, Tiberti A. Absent end-diastolic velocity in umbilical artery: risk of neonatal morbidity and brain damage. Am J Obstet Gynecol. 1994 Mar;170(3):796-801. doi: 10.1016/s0002-9378(94)70285-3. |
| 15287053 | Background | Gratacos E, Carreras E, Becker J, Lewi L, Enriquez G, Perapoch J, Higueras T, Cabero L, Deprest J. Prevalence of neurological damage in monochorionic twins with selective intrauterine growth restriction and intermittent absent or reversed end-diastolic umbilical artery flow. Ultrasound Obstet Gynecol. 2004 Aug;24(2):159-63. doi: 10.1002/uog.1105. |
| 16323150 | Background | Huber A, Diehl W, Zikulnig L, Bregenzer T, Hackeloer BJ, Hecher K. Perinatal outcome in monochorionic twin pregnancies complicated by amniotic fluid discordance without severe twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2006 Jan;27(1):48-52. doi: 10.1002/uog.2655. |
| 2342732 | Background | De Lia JE, Cruikshank DP, Keye WR Jr. Fetoscopic neodymium:YAG laser occlusion of placental vessels in severe twin-twin transfusion syndrome. Obstet Gynecol. 1990 Jun;75(6):1046-53. |
| 2916637 | Background | DeLia JE, Cukierski MA, Lundergan DK, Kochenour NK. Neodymium:yttrium-aluminum-garnet laser occlusion of rhesus placental vasculature via fetoscopy. Am J Obstet Gynecol. 1989 Feb;160(2):485-9. doi: 10.1016/0002-9378(89)90477-8. |
| 4039109 | Background | DeLia JE, Rogers JG, Dixon JA. Treatment of placental vasculature with a neodymium-yttrium-aluminum-garnet laser via fetoscopy. Am J Obstet Gynecol. 1985 Apr 15;151(8):1126-7. doi: 10.1016/0002-9378(85)90395-3. |
| 7808488 | Background | Ville Y, Hyett J, Hecher K, Nicolaides K. Preliminary experience with endoscopic laser surgery for severe twin-twin transfusion syndrome. N Engl J Med. 1995 Jan 26;332(4):224-7. doi: 10.1056/NEJM199501263320404. |
| 9870237 | Background | Quintero RA, Morales WJ, Mendoza G, Allen M, Kalter CS, Giannina G, Angel JL. Selective photocoagulation of placental vessels in twin-twin transfusion syndrome: evolution of a surgical technique. Obstet Gynecol Surv. 1998 Dec;53(12 Suppl):S97-103. doi: 10.1097/00006254-199812010-00001. No abstract available. |
| 8843613 | Background | Quintero RA, Romero R, Reich H, Goncalves L, Johnson MP, Carreno C, Evans MI. In utero percutaneous umbilical cord ligation in the management of complicated monochorionic multiple gestations. Ultrasound Obstet Gynecol. 1996 Jul;8(1):16-22. doi: 10.1046/j.1469-0705.1996.08010016.x. |
| 16522413 | Background | Lewi L, Gratacos E, Ortibus E, Van Schoubroeck D, Carreras E, Higueras T, Perapoch J, Deprest J. Pregnancy and infant outcome of 80 consecutive cord coagulations in complicated monochorionic multiple pregnancies. Am J Obstet Gynecol. 2006 Mar;194(3):782-9. doi: 10.1016/j.ajog.2005.09.013. |
| 16167936 | Background | Robyr R, Yamamoto M, Ville Y. Selective feticide in complicated monochorionic twin pregnancies using ultrasound-guided bipolar cord coagulation. BJOG. 2005 Oct;112(10):1344-8. doi: 10.1111/j.1471-0528.2005.00746.x. |
| 11568799 | Background | Quintero RA, Bornick PW, Morales WJ, Allen MH. Selective photocoagulation of communicating vessels in the treatment of monochorionic twins with selective growth retardation. Am J Obstet Gynecol. 2001 Sep;185(3):689-96. doi: 10.1067/mob.2001.116724. |
| 1887021 | Background | Hadlock FP, Harrist RB, Martinez-Poyer J. In utero analysis of fetal growth: a sonographic weight standard. Radiology. 1991 Oct;181(1):129-33. doi: 10.1148/radiology.181.1.1887021. |
| 3055996 | Background | Arduini D, Rizzo G, Mancuso S, Romanini C. Short-term effects of maternal oxygen administration on blood flow velocity waveforms in healthy and growth-retarded fetuses. Am J Obstet Gynecol. 1988 Nov;159(5):1077-80. doi: 10.1016/0002-9378(88)90417-6. |
| 12942495 | Background | Martinez JM, Bermudez C, Becerra C, Lopez J, Morales WJ, Quintero RA. The role of Doppler studies in predicting individual intrauterine fetal demise after laser therapy for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2003 Sep;22(3):246-51. doi: 10.1002/uog.215. |
| 11169288 | Background | Quintero RA, Comas C, Bornick PW, Allen MH, Kruger M. Selective versus non-selective laser photocoagulation of placental vessels in twin-to-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2000 Sep;16(3):230-6. doi: 10.1046/j.1469-0705.2000.00265.x. |
| Background | Quintero R. Diagnostic and Operative Fetoscopy. New York: The Parthenon Publishing Group, 2002. |
| 12748508 | Background | Quintero RA, Dickinson JE, Morales WJ, Bornick PW, Bermudez C, Cincotta R, Chan FY, Allen MH. Stage-based treatment of twin-twin transfusion syndrome. Am J Obstet Gynecol. 2003 May;188(5):1333-40. doi: 10.1067/mob.2003.292. |
| 1550147 | Background | Saunders NJ, Snijders RJ, Nicolaides KH. Therapeutic amniocentesis in twin-twin transfusion syndrome appearing in the second trimester of pregnancy. Am J Obstet Gynecol. 1992 Mar;166(3):820-4. doi: 10.1016/0002-9378(92)91340-g. |
| Background | Morales W. Selective photocoagulation of placental vessels in twin-twin transfusion syndrome: outcomes and complications. In: Quintero R, ed. Twin-twin transfusion syndrome. London: Taylor and Francis, Scheduled for publication in 2006. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management. | Posted | Number | percentage of AGA babies who survived | 6 months |
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| 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. | Not Posted | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 2 | 0 | 2 | ||
| EG001 | 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. | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | University of South Florida | 813-259-8680 | obgynclinicalresearch@health.usf.edu |
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
|