Twin Twin Transfusion SyndromeNCT03449823
Renal Artery Dopplers in Twin Twin Transfusion Syndrome
An observational study of Twin Twin Transfusion Syndrome, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Twin Twin Transfusion Syndrome
- What is being tested?
- Doppler ultrasound of fetal renal artery
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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).
Who may be able to join
- pregnant women with monochorionic / diamniotic (MCDA) twin pregnancies with and without twin-twin transfusion syndrome (TTTS)
- greater than 14 weeks gestation
Who cannot join
- higher-order multiple gestation
- sonographic evidence of a major structural fetal anomaly (exceptions to this structural fetal anomaly exclusion are acquired recipient twin cardiac changes that are known to be associated with TTTS - these cases may be considered for study inclusion)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Are Renal Artery Doppler Indices Different Between Monochorionic Diamniotic Twins With Twin-twin Transfusion Syndrome and Monochorionic Diamniotic Twins Without Twin-twin Transfusion Syndrome?
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.
Read more
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.
Read the detailed description
TTTS, which complicates 10-15% of MCDA twin pregnancies, is characterized by a net imbalance of volume between twins, mediated through abnormal placental blood vessel anastomoses that connect the two placental circulations. Clinically, the "donor" twin develops features of anemia and hypovolemia, while the "recipient" twin shows signs of hypervolemia and hypertensive fluid overload. If untreated, the syndrome has a perinatal mortality rate as high as 80-100%. Although modern intrauterine therapies have improved the rates of fetal death, significant risks of morbidity and mortality remain even after treatment.
Twin-twin transfusion syndrome is most commonly classified according to a staging system developed by Quintero et al in 1999, which is based on discrete, categorical ultrasound findings (amniotic fluid volume, presence/absence of a fetal bladder, umbilical artery Doppler studies, fetal hydrops, and death). The system includes 5 stages ranging from mild disease with isolated discordant amniotic fluid volumes, to severe disease with demise of one or both twins. Although this system has some prognostic value, it also has significant limitations due to the highly complex physiologic conditions that are involved in the disease. For example, some criteria in the staging system are not consistently representative of fetal physiology. Additionally, the stages do not correlate well with overall perinatal survival or with outcomes following intrauterine therapies.
Recent work has demonstrated that the complex pathophysiology of twin-twin transfusion syndrome involves a discordant activation of the renin angiotensin system (RAS). RAS is normally important in fluid and salt regulation in both the adult and the fetus, and TTTS in marked hypovolemia and hypervolemia in monozygous fetuses within the same maternal environment. The renal RAS in the donor is up-regulated, presumably as a consequence of hypovolemia. The recipient is also exposed to high levels or RAS components, either due to the transfusion of these components from the donor via anastomoses, or via discordant placental RAS activation, resulting in a hypertensive, hypervolemic state.
Multiple studies have identified a correlation between Doppler assessment of the fetal renal artery and the development of oligohydramnios, a hypovolemic state, in singleton pregnancies. However, the use of renal artery Doppler studies has not yet been fully evaluated in twin gestations. In particular, it has not been evaluated in MCDA twin gestations complicated by TTTS, the pathophysiology of which involves significant alterations in fetal volume and fluid status.
This project is intended to serve as a single-center study to determine if there is indeed a difference in renal artery Doppler parameters in sets of MCDA twins with TTTS compared to sets of MCDA twins without TTTS. The identification of a significant difference would potentially provide support for further investigation into this measurement as a screening tool or prognostic indicator when applied to MCDA twin pregnancies.
Secondary goals of this study include: comparing donor to recipient renal artery Doppler findings among pregnancies with TTTS, evaluating serial renal artery Doppler findings over time per pregnancy, and evaluating pre- and post-therapy renal artery Doppler findings in those pregnancies undergoing therapy for TTTS.
- Conditions
- Twin Twin Transfusion Syndrome
- Being tested
- Doppler ultrasound of fetal renal artery
- Keywords
- Renal Artery Doppler
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasound of fetal renal arteryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| TTTS Cases | Cases of monochorionic / diamniotic twin pregnancies diagnosed with twin-twin transfusion syndrome. Receives: Diagnostic Test: Doppler ultrasound of fetal renal artery | |
| MCDA Controls | Controls of monochorionic / diamniotic twin pregnancies without a diagnosis of twin-twin transfusion syndrome. Receives: Diagnostic Test: Doppler ultrasound of fetal renal artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Obtained at the time of enrollment.
Secondary outcomes (6)
Post-laser 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.
Measured: 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
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin A.
Measured: 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
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin A.
Measured: 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
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin B.
Measured: 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
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin B.
Measured: 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 B
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin B.
Measured: Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start9 Sep 2016
- Primary completion21 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Twin Twin Transfusion SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Miller, Columbia University
- Investigators
- Joses Jain, MD, Study director, Columbia UniversityRussell Miller, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449823
- Sponsor's protocol ID
- AAAQ9660
- Status last verified
- Jul 2018
- First submitted
- 7 Feb 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Publications
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.
PubMed 23200164Lewi 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.
PubMed 18533114Acosta-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.
PubMed 17250837Fusi 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.
PubMed 2198920van 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.
PubMed 9699754Ong 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.
PubMed 16903844Quintero 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.
PubMed 10645517Taylor 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.
PubMed 12468171Yamamoto 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.
PubMed 16157121Taylor 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.
PubMed 3007602Galea 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.
PubMed 18558429Arduini 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.
PubMed 1992401Stigter 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.
PubMed 11529994Oz 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.
PubMed 12383539Azpurua 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.
PubMed 19185102
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Renal Artery Doppler Indices Different Between Monochorionic Diamniotic Twins With Twin-twin Transfusion Syndrome and Monochorionic Diamniotic Twins Without Twin-twin Transfusion Syndrome?
- ClinicalTrials.gov ID
- NCT03449823
- Acronym / sponsor ID
- AAAQ9660
- Conditions
- Twin Twin Transfusion Syndrome
- Keywords
- Renal Artery Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TTTS, which complicates 10-15% of MCDA twin pregnancies, is characterized by a net imbalance of volume between twins, mediated through abnormal placental blood vessel anastomoses that connect the two placental circulations. Clinically, the "donor" twin develops features of anemia and hypovolemia, while the "recipient" twin shows signs of hypervolemia and hypertensive fluid overload. If untreated, the syndrome has a perinatal mortality rate as high as 80-100%. Although modern intrauterine therapies have improved the rates of fetal death, significant risks of morbidity and mortality remain even after treatment.
Twin-twin transfusion syndrome is most commonly classified according to a staging system developed by Quintero et al in 1999, which is based on discrete, categorical ultrasound findings (amniotic fluid volume, presence/absence of a fetal bladder, umbilical artery Doppler studies, fetal hydrops, and death). The system includes 5 stages ranging from mild disease with isolated discordant amniotic fluid volumes, to severe disease with demise of one or both twins. Although this system has some prognostic value, it also has significant limitations due to the highly complex physiologic conditions that are involved in the disease. For example, some criteria in the staging system are not consistently representative of fetal physiology. Additionally, the stages do not correlate well with overall perinatal survival or with outcomes following intrauterine therapies.
Recent work has demonstrated that the complex pathophysiology of twin-twin transfusion syndrome involves a discordant activation of the renin angiotensin system (RAS). RAS is normally important in fluid and salt regulation in both the adult and the fetus, and TTTS in marked hypovolemia and hypervolemia in monozygous fetuses within the same maternal environment. The renal RAS in the donor is up-regulated, presumably as a consequence of hypovolemia. The recipient is also exposed to high levels or RAS components, either due to the transfusion of these components from the donor via anastomoses, or via discordant placental RAS activation, resulting in a hypertensive, hypervolemic state.
Multiple studies have identified a correlation between Doppler assessment of the fetal renal artery and the development of oligohydramnios, a hypovolemic state, in singleton pregnancies. However, the use of renal artery Doppler studies has not yet been fully evaluated in twin gestations. In particular, it has not been evaluated in MCDA twin gestations complicated by TTTS, the pathophysiology of which involves significant alterations in fetal volume and fluid status.
This project is intended to serve as a single-center study to determine if there is indeed a difference in renal artery Doppler parameters in sets of MCDA twins with TTTS compared to sets of MCDA twins without TTTS. The identification of a significant difference would potentially provide support for further investigation into this measurement as a screening tool or prognostic indicator when applied to MCDA twin pregnancies.
Secondary goals of this study include: comparing donor to recipient renal artery Doppler findings among pregnancies with TTTS, evaluating serial renal artery Doppler findings over time per pregnancy, and evaluating pre- and post-therapy renal artery Doppler findings in those pregnancies undergoing therapy for TTTS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTTS Cases | – | Diagnostic Test: Doppler ultrasound of fetal renal arteryCases of monochorionic / diamniotic twin pregnancies diagnosed with twin-twin transfusion syndrome. |
| MCDA Controls | – | Diagnostic Test: Doppler ultrasound of fetal renal arteryControls of monochorionic / diamniotic twin pregnancies without a diagnosis of twin-twin transfusion syndrome. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- pregnant women with monochorionic / diamniotic (MCDA) twin pregnancies with and without twin-twin transfusion syndrome (TTTS)
- greater than 14 weeks gestation
Key exclusion criteria (2 listed)
- higher-order multiple gestation
- sonographic evidence of a major structural fetal anomaly (exceptions to this structural fetal anomaly exclusion are acquired recipient twin cardiac changes that are known to be associated with TTTS - these cases may be considered for study inclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasound of fetal renal arteryDoppler ultrasound assessment of the proximal fetal renal artery to with measurement of the peak systolic velocity, resistive index, pulsatility index, and systolic/diastolic ratio. | Diagnostic test | MCDA Controls, TTTS Cases |
Primary outcome
Fetal renal artery Doppler PSV for twin A
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin A.
Fetal renal artery Doppler RI for twin A
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin A.
Fetal renal artery Doppler PI for twin A
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin A.
Fetal renal artery Doppler PSV for twin B
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the peak systolic velocity for twin B.
Fetal renal artery Doppler RI for twin B
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the resistive index for twin B.
Fetal renal artery Doppler PI for twin B
Time frame: Obtained at the time of enrollment.
Doppler ultrasound assessment of the proximal fetal renal artery with measurement of the pulsatility index for twin B.
6 secondary outcomes
Post-laser fetal renal artery Doppler PSV for twin A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 B
Time frame: Obtained within one week following fetoscopic laser therapy for cases in which this treatment is provided.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 23200164Society 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.
- Background: PubMed 18533114Lewi 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.
- Background: PubMed 17250837Acosta-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.
- Background: PubMed 2198920Fusi 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.
- Background: PubMed 9699754van 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.
- Background: PubMed 16903844Ong 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.
- Background: PubMed 10645517Quintero 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.
- Background: PubMed 12468171Taylor 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.
- Background: PubMed 16157121Yamamoto 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.
- Background: PubMed 3007602Taylor 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.
- Background: PubMed 18558429Galea 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.
- Background: PubMed 1992401Arduini 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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Twin to Twin Transfusion
Not yet recruiting
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Twin to Twin Transfusion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joses Jain, MD study director
Columbia University
Russell Miller, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Twin Transfusion Syndrome, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal renal artery Doppler PSV for twin A (time frame: Obtained at the time of enrollment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449823, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.