Renal Artery Dopplers in Twin Twin Transfusion Syndrome

NCT03449823 | Completed

• 1 other identifier: AAAQ9660
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Twin Twin Transfusion Syndrome

Keywords

Renal Artery Doppler

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

Secondary Outcomes (6)

• 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.

Study Arms (2)

TTTS Cases

Cases of monochorionic / diamniotic twin pregnancies diagnosed with twin-twin transfusion syndrome.

Diagnostic Test: Doppler ultrasound of fetal renal artery

MCDA Controls

Controls of monochorionic / diamniotic twin pregnancies without a diagnosis of twin-twin transfusion syndrome.

Diagnostic Test: Doppler ultrasound of fetal renal artery

Interventions

Doppler ultrasound of fetal renal artery DIAGNOSTIC_TEST

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.

MCDA Controls; TTTS Cases

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• pregnant women with monochorionic / diamniotic (MCDA) twin pregnancies with and without twin-twin transfusion syndrome (TTTS)
• greater than 14 weeks gestation

You may not qualify if:

• higher-order multiple gestation

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (16)

• 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.

  PMID: 23200164 BACKGROUND

• 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.

  PMID: 18533114 BACKGROUND

• 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.

  PMID: 17250837 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.

  PMID: 2198920 BACKGROUND

• 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.

  PMID: 9699754 BACKGROUND

• 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.

  PMID: 16903844 BACKGROUND

• 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.

  PMID: 10645517 BACKGROUND

• 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.

  PMID: 12468171 BACKGROUND

• 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.

  PMID: 16157121 BACKGROUND

• 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.

  PMID: 3007602 BACKGROUND

• 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.

  PMID: 18558429 BACKGROUND

• 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.

  PMID: 1992401 BACKGROUND

• 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.

  PMID: 11529994 BACKGROUND

• 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.

  PMID: 12383539 BACKGROUND

• 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.

  PMID: 19185102 BACKGROUND

• 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.

  PMID: 25363086 BACKGROUND

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joses Jain, MD

  Columbia University

  STUDY DIRECTOR

• Russell Miller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 28, 2018
• Study Start: September 9, 2016
• Primary Completion: March 21, 2018
• Study Completion: June 30, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)