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Are Renal Artery Doppler Indices Different Between Monochorionic Diamniotic Twins With Twin-twin Transfusion Syndrome and Monochorionic Diamniotic Twins Without Twin-twin Transfusion Syndrome?
Sponsor study identifier
observational
24
1 country
1
Study Start
September 9, 2016
Actual (reported)Primary Completion
March 21, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Twin-twin transfusion syndrome (TTTS) is a complication affecting 10-15% of monochorionic, diamniotic (MCDA) twin pregnancies. Unevenly distributed blood flow across a shared placental circulation results in a volume-restricted donor twin and a volume-overloaded recipient twin, and TTTS has high perinatal morbidity and mortality without treatment. Differential donor and recipient findings in TTTS can be observed upon ultrasound evaluation. TTTS is classified according to the Quintero staging system, which evaluates amniotic fluid volumes, fetal bladders, Doppler study of the umbilical artery and ductus venosus, and for the presence of hydrops or death. However, due to seemingly complex and variable disease pathophysiology, the Quintero system cannot predict outcomes on a case-by-case basis. Prior studies have associated fetal renal artery Doppler ultrasound measurements with amniotic fluid volume in singleton pregnancies. In fetuses with placental insufficiency, adaptive circulatory changes maintain adequate oxygen delivery to vital organs such as the heart, brain, and adrenals, with a consequent deprivation to splanchnic organs. In the fetal kidney, as vascular resistance increases during hypoxia, renal perfusion decreases proportionately. These changes are reflected in renal artery Doppler findings. As these same adaptations are believed to occur in donor twins, renal artery Doppler studies may also be of value in the TTTS evaluation. This study plans to perform renal artery Doppler assessments in MCDA twins complicated by TTTS, and compare them to measurements in gestational-age equivalent MCDA twins without TTTS. If findings differ significantly, it would support further investigation into the use of renal artery Doppler studies for the evaluation of complicated MCDA twins.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2016
Actual (reported)February 7, 2018
Actual (reported)February 28, 2018
Actual (reported)March 21, 2018
Actual (reported)June 30, 2018
Actual (reported)Fetal renal artery Doppler PSV for twin A
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin A.
Obtained at the time of enrollment.
Fetal renal artery Doppler RI for twin A
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin A.
Obtained at the time of enrollment.
Fetal renal artery Doppler PI for twin A
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin A.
Obtained at the time of enrollment.
Fetal renal artery Doppler PSV for twin B
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin B.
Obtained at the time of enrollment.
Fetal renal artery Doppler RI for twin B
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin B.
Post-laser fetal renal artery Doppler PSV for twin A
Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Post-laser fetal renal artery Doppler RI for twin A
Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Post-laser fetal renal artery Doppler PI for twin A
Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Post-laser fetal renal artery Doppler PSV for twin B
Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Post-laser fetal renal artery Doppler RI for twin B
Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Cases of monochorionic / diamniotic twin pregnancies diagnosed with twin-twin transfusion syndrome.
Controls of monochorionic / diamniotic twin pregnancies without a diagnosis of twin-twin transfusion syndrome.
Doppler ultrasound assessment of the proximal fetal renal artery to with measurement of the peak systolic velocity, resistive index, pulsatility index, and systolic/diastolic ratio.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The subject population will consist of pregnant women with monochorionic / diamniotic (MCDA) twin pregnancies with and without twin-twin transfusion syndrome (TTTS). This population is selected in order to investigate twin-twin transfusion syndrome, which is a disease process that is unique to pregnancies with monochorionic / diamniotic twins. Patients will be included in the study if they have a diagnosis of a MCDA twin gestation beyond the first trimester or pregnancy (greater than 14 weeks gestation).
Columbia University Medical Center
New York, New York, 10032, United States
Society for Maternal-Fetal Medicine; Simpson LL. Twin-twin transfusion syndrome. Am J Obstet Gynecol. 2013 Jan;208(1):3-18. doi: 10.1016/j.ajog.2012.10.880. Epub 2012 Nov 27.
Lewi L, Jani J, Blickstein I, Huber A, Gucciardo L, Van Mieghem T, Done E, Boes AS, Hecher K, Gratacos E, Lewi P, Deprest J. The outcome of monochorionic diamniotic twin gestations in the era of invasive fetal therapy: a prospective cohort study. Am J Obstet Gynecol. 2008 Nov;199(5):514.e1-8. doi: 10.1016/j.ajog.2008.03.050. Epub 2008 Jun 4.
Joses Jain, MD
Columbia University
Russell Miller, MD
Columbia University
24 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2018
First Posted
February 28, 2018
Study Start
September 9, 2016
Actual (reported)Obtained at the time of enrollment.
Fetal renal artery Doppler PI for twin B
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin B.
Obtained at the time of enrollment.
Contact the study team to confirm eligibility.
Acosta-Rojas R, Becker J, Munoz-Abellana B, Ruiz C, Carreras E, Gratacos E; Catalunya and Balears Monochorionic Network. Twin chorionicity and the risk of adverse perinatal outcome. Int J Gynaecol Obstet. 2007 Feb;96(2):98-102. doi: 10.1016/j.ijgo.2006.11.002. Epub 2007 Jan 23.
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van Heteren CF, Nijhuis JG, Semmekrot BA, Mulders LG, van den Berg PP. Risk for surviving twin after fetal death of co-twin in twin-twin transfusion syndrome. Obstet Gynecol. 1998 Aug;92(2):215-9. doi: 10.1016/s0029-7844(98)00159-8.
Ong SS, Zamora J, Khan KS, Kilby MD. Prognosis for the co-twin following single-twin death: a systematic review. BJOG. 2006 Sep;113(9):992-8. doi: 10.1111/j.1471-0528.2006.01027.x. Epub 2006 Aug 10.
Quintero RA, Morales WJ, Allen MH, Bornick PW, Johnson PK, Kruger M. Staging of twin-twin transfusion syndrome. J Perinatol. 1999 Dec;19(8 Pt 1):550-5. doi: 10.1038/sj.jp.7200292.
Taylor MJ, Govender L, Jolly M, Wee L, Fisk NM. Validation of the Quintero staging system for twin-twin transfusion syndrome. Obstet Gynecol. 2002 Dec;100(6):1257-65. doi: 10.1016/s0029-7844(02)02392-x.
Yamamoto M, El Murr L, Robyr R, Leleu F, Takahashi Y, Ville Y. Incidence and impact of perioperative complications in 175 fetoscopy-guided laser coagulations of chorionic plate anastomoses in fetofetal transfusion syndrome before 26 weeks of gestation. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1110-6. doi: 10.1016/j.ajog.2005.07.003.
Taylor GM, Peart WS, Porter KA, Zondek LH, Zondek T. Concentration and molecular forms of active and inactive renin in human fetal kidney, amniotic fluid and adrenal gland: evidence for renin-angiotensin system hyperactivity in 2nd trimester of pregnancy. J Hypertens. 1986 Feb;4(1):121-9. doi: 10.1097/00004872-198602000-00019.
Galea P, Barigye O, Wee L, Jain V, Sullivan M, Fisk NM. The placenta contributes to activation of the renin angiotensin system in twin-twin transfusion syndrome. Placenta. 2008 Aug;29(8):734-42. doi: 10.1016/j.placenta.2008.04.010. Epub 2008 Jun 16.
Arduini D, Rizzo G. Fetal renal artery velocity waveforms and amniotic fluid volume in growth-retarded and post-term fetuses. Obstet Gynecol. 1991 Mar;77(3):370-3.
Stigter RH, Mulder EJ, Bruinse HW, Visser GH. Doppler studies on the fetal renal artery in the severely growth-restricted fetus. Ultrasound Obstet Gynecol. 2001 Aug;18(2):141-5. doi: 10.1046/j.1469-0705.2001.00493.x.
Oz AU, Holub B, Mendilcioglu I, Mari G, Bahado-Singh RO. Renal artery Doppler investigation of the etiology of oligohydramnios in postterm pregnancy. Obstet Gynecol. 2002 Oct;100(4):715-8. doi: 10.1016/s0029-7844(02)02203-2.
Azpurua H, Dulay AT, Buhimschi IA, Bahtiyar MO, Funai E, Abdel-Razeq SS, Luo G, Bhandari V, Copel JA, Buhimschi CS. Fetal renal artery impedance as assessed by Doppler ultrasound in pregnancies complicated by intraamniotic inflammation and preterm birth. Am J Obstet Gynecol. 2009 Feb;200(2):203.e1-11. doi: 10.1016/j.ajog.2008.11.001.
Benzer N, Pekin AT, Yilmaz SA, Kerimoglu OS, Dogan NU, Celik C. Predictive value of second and third trimester fetal renal artery Doppler indices in idiopathic oligohydramnios and polyhydramnios in low-risk pregnancies: a longitudinal study. J Obstet Gynaecol Res. 2015 Apr;41(4):523-8. doi: 10.1111/jog.12601. Epub 2014 Nov 3.
Primary Completion
March 21, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Last Updated
July 18, 2018
Record last verified: 2018-07
There is no plan to share individual participant data with other researchers.
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Source: ClinicalTrials.gov.
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