Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study

NCT03024918 | Recruiting

• 1 other identifier: S5877
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study in 3 cohorts of monochorionic diamniotic (MCDA) twins. The aim of the study is to assess whether unequal placental sharing can be predicted in pregnancy and whether it is predictive of pregnancy outcome.

Conditions

Monochorionic Twins

Keywords

monochorionic; placental sharing

Outcome Measures

Primary Outcomes (3)

• MCDA cohort: the association between unequal sharing and risk of fetal or neonatal loss (assessed by review of obstetric and pediatric records)

  2 weeks after expected date of birth

• TTTS cohort: the association between unequal sharing and intrauterine fetal death (assessed by review of obstetric records)

  2 weeks after expected date of birth

• sIUGR cohort: the association between unequal sharing and risk of fetal or neonatal loss and birth prior to 34 weeks (assessed by review of obstetric and pediatric records)

  2 weeks after expected date of birth

Secondary Outcomes (2)

• The correlation between prenatal ultrasound and MRI variables and placental sharing as assessed by postnatal imaging (all cohorts)

  2 weeks after expected date of birth

• The association between unequal sharing and intact survival (all cohorts) (assessed by review of obstetric and pediatric records and parent questionnaire)

  2 years after expected date of birth

Study Arms (3)

MCDA cohort

Unselected monochorionic diamniotic (MCDA) twin pregnancies, included between 11 and 14 weeks of gestation

TTTS cohort

Pregnancies complicated by twin-twin transfusion syndrome (TTTS) undergoing laser treatment, included at the time of diagnosis or referral

sIUGR cohort

Pregnancies complicated by selective intrauterine growth restriction (sIUGR), included at the time of diagnosis or referral. We define sIUGR as a discordance in estimated fetal weight of ≥ 20%.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population exists of women with a monochorionic twin pregnancy. Three cohorts will be created: a cohort of uncomplicated MCDA twins (included at the first trimester scan), a cohort of MCDA twins complicated by TTTS and undergoing laser surgery (included at the time of diagnosis) and a cohort of MCDA twins complicated by selective growth restriction (included at the time of diagnosis).

You may qualify if:

• MCDA cohort
• Ongoing monochorionic diamniotic twin pregnancy between 11 and 14 weeks, as determined by the crown rump length of the larger twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment
• Women aged 18 years or more, who are able to consent
• Written informed consent to participate in this study, forms being approved by the Ethical Committees
• TTTS cohort
• Monochorionic diamniotic twin pregnancy, with gestational age defined in the first trimester as mentioned above
• Complicated by TTTS according to the definition used in the Quintero staging of TTTS (DVP of donor \< 2 cm and DVP of receptor \> 8 cm before 20 weeks or \> 10 cm after 20 weeks
• Undergoing laser surgery for TTTS
• Women aged 18 years or more, who are able to consent
• Written informed consent to participate in this study, forms being approved by the Ethical Committees
• sIUGR cohort
• Monochorionic diamniotic twin pregnancy, with gestational age defined in the first trimester as mentioned above
• Complicated by sIUGR defined as a discordance in EFW of ≥ 20%, with the percentage of discordance being calculated as (EFW larger twin - EFW smaller twin)/EFW larger twin x 100.
• Women aged 18 years or more, who are able to consent
• Written informed consent to participate in this study, forms being approved by the Ethical Committees

You may not qualify if:

• Age \< 18 years
• Inability to consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (31)

• 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

• Lewi L, Gucciardo L, Huber A, Jani J, Van Mieghem T, Done E, Cannie M, Gratacos E, Diemert A, Hecher K, Lewi P, Deprest J. Clinical outcome and placental characteristics of monochorionic diamniotic twin pairs with early- and late-onset discordant growth. Am J Obstet Gynecol. 2008 Nov;199(5):511.e1-7. doi: 10.1016/j.ajog.2008.04.022. Epub 2008 Jun 9.

  PMID: 18539257 BACKGROUND

• Cavicchioni O, Yamamoto M, Robyr R, Takahashi Y, Ville Y. Intrauterine fetal demise following laser treatment in twin-to-twin transfusion syndrome. BJOG. 2006 May;113(5):590-4. doi: 10.1111/j.1471-0528.2006.00913.x. Epub 2006 Mar 27.

  PMID: 16579799 BACKGROUND

• Lopriore E, Sueters M, Middeldorp JM, Oepkes D, Walther FJ, Vandenbussche FP. Velamentous cord insertion and unequal placental territories in monochorionic twins with and without twin-to-twin-transfusion syndrome. Am J Obstet Gynecol. 2007 Feb;196(2):159.e1-5. doi: 10.1016/j.ajog.2006.10.865.

  PMID: 17306663 BACKGROUND

• Lopriore E, Pasman SA, Klumper FJ, Middeldorp JM, Walther FJ, Oepkes D. Placental characteristics in growth-discordant monochorionic twins: a matched case-control study. Placenta. 2012 Mar;33(3):171-4. doi: 10.1016/j.placenta.2011.12.004. Epub 2011 Dec 23.

  PMID: 22197628 BACKGROUND

• Aston KI, Peterson CM, Carrell DT. Monozygotic twinning associated with assisted reproductive technologies: a review. Reproduction. 2008 Oct;136(4):377-86. doi: 10.1530/REP-08-0206. Epub 2008 Jun 24.

  PMID: 18577552 BACKGROUND

• Lewi L, Deprest J, Hecher K. The vascular anastomoses in monochorionic twin pregnancies and their clinical consequences. Am J Obstet Gynecol. 2013 Jan;208(1):19-30. doi: 10.1016/j.ajog.2012.09.025. Epub 2012 Sep 28.

  PMID: 23103301 BACKGROUND

• Kent EM, Breathnach FM, Gillan JE, McAuliffe FM, Geary MP, Daly S, Higgins JR, Dornan J, Morrison JJ, Burke G, Higgins S, Carroll S, Dicker P, Manning F, Malone FD. Placental cord insertion and birthweight discordance in twin pregnancies: results of the national prospective ESPRiT Study. Am J Obstet Gynecol. 2011 Oct;205(4):376.e1-7. doi: 10.1016/j.ajog.2011.06.077. Epub 2011 Jun 25.

  PMID: 21864823 BACKGROUND

• Monk D. Genomic imprinting in the human placenta. Am J Obstet Gynecol. 2015 Oct;213(4 Suppl):S152-62. doi: 10.1016/j.ajog.2015.06.032.

  PMID: 26428495 BACKGROUND

• Su EJ. Role of the fetoplacental endothelium in fetal growth restriction with abnormal umbilical artery Doppler velocimetry. Am J Obstet Gynecol. 2015 Oct;213(4 Suppl):S123-30. doi: 10.1016/j.ajog.2015.06.038.

  PMID: 26428491 BACKGROUND

• Su EJ, Xin H, Yin P, Dyson M, Coon J, Farrow KN, Mestan KK, Ernst LM. Impaired fetoplacental angiogenesis in growth-restricted fetuses with abnormal umbilical artery doppler velocimetry is mediated by aryl hydrocarbon receptor nuclear translocator (ARNT). J Clin Endocrinol Metab. 2015 Jan;100(1):E30-40. doi: 10.1210/jc.2014-2385.

  PMID: 25343232 BACKGROUND

• Gratacos E, Lewi L, Munoz B, Acosta-Rojas R, Hernandez-Andrade E, Martinez JM, Carreras E, Deprest J. A classification system for selective intrauterine growth restriction in monochorionic pregnancies according to umbilical artery Doppler flow in the smaller twin. Ultrasound Obstet Gynecol. 2007 Jul;30(1):28-34. doi: 10.1002/uog.4046.

  PMID: 17542039 BACKGROUND

• Ishii K, Murakoshi T, Takahashi Y, Shinno T, Matsushita M, Naruse H, Torii Y, Sumie M, Nakata M. Perinatal outcome of monochorionic twins with selective intrauterine growth restriction and different types of umbilical artery Doppler under expectant management. Fetal Diagn Ther. 2009;26(3):157-61. doi: 10.1159/000253880. Epub 2009 Oct 28.

  PMID: 19864880 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.

  PMID: 15287053 BACKGROUND

• Peeva G, Bower S, Orosz L, Chaveeva P, Akolekar R, Nicolaides KH. Endoscopic Placental Laser Coagulation in Monochorionic Diamniotic Twins with Type II Selective Fetal Growth Restriction. Fetal Diagn Ther. 2015;38(2):86-93. doi: 10.1159/000374109. Epub 2015 Apr 15.

  PMID: 25896405 BACKGROUND

• Parra-Cordero M, Bennasar M, Martinez JM, Eixarch E, Torres X, Gratacos E. Cord Occlusion in Monochorionic Twins with Early Selective Intrauterine Growth Restriction and Abnormal Umbilical Artery Doppler: A Consecutive Series of 90 Cases. Fetal Diagn Ther. 2016;39(3):186-91. doi: 10.1159/000439023. Epub 2015 Sep 8.

  PMID: 26344150 BACKGROUND

• Chalouhi GE, Marangoni MA, Quibel T, Deloison B, Benzina N, Essaoui M, Al Ibrahim A, Stirnemann JJ, Salomon LJ, Ville Y. Active management of selective intrauterine growth restriction with abnormal Doppler in monochorionic diamniotic twin pregnancies diagnosed in the second trimester of pregnancy. Prenat Diagn. 2013 Feb;33(2):109-15. doi: 10.1002/pd.4031. Epub 2012 Dec 26.

  PMID: 23280487 BACKGROUND

• Bonel HM, Stolz B, Diedrichsen L, Frei K, Saar B, Tutschek B, Raio L, Surbek D, Srivastav S, Nelle M, Slotboom J, Wiest R. Diffusion-weighted MR imaging of the placenta in fetuses with placental insufficiency. Radiology. 2010 Dec;257(3):810-9. doi: 10.1148/radiol.10092283.

  PMID: 21084415 BACKGROUND

• Derwig I, Lythgoe DJ, Barker GJ, Poon L, Gowland P, Yeung R, Zelaya F, Nicolaides K. Association of placental perfusion, as assessed by magnetic resonance imaging and uterine artery Doppler ultrasound, and its relationship to pregnancy outcome. Placenta. 2013 Oct;34(10):885-91. doi: 10.1016/j.placenta.2013.07.006. Epub 2013 Aug 9.

  PMID: 23937958 BACKGROUND

• Lewi L, Cannie M, Blickstein I, Jani J, Huber A, Hecher K, Dymarkowski S, Gratacos E, Lewi P, Deprest J. Placental sharing, birthweight discordance, and vascular anastomoses in monochorionic diamniotic twin placentas. Am J Obstet Gynecol. 2007 Dec;197(6):587.e1-8. doi: 10.1016/j.ajog.2007.05.009.

  PMID: 18060944 BACKGROUND

• De Paepe ME, Shapiro S, Young L, Luks FI. Placental characteristics of selective birth weight discordance in diamniotic-monochorionic twin gestations. Placenta. 2010 May;31(5):380-6. doi: 10.1016/j.placenta.2010.02.018. Epub 2010 Mar 19.

  PMID: 20303588 BACKGROUND

• Janzen C, Lei MY, Cho J, Sullivan P, Shin BC, Devaskar SU. Placental glucose transporter 3 (GLUT3) is up-regulated in human pregnancies complicated by late-onset intrauterine growth restriction. Placenta. 2013 Nov;34(11):1072-8. doi: 10.1016/j.placenta.2013.08.010. Epub 2013 Aug 28.

  PMID: 24011442 BACKGROUND

• Yung HW, Calabrese S, Hynx D, Hemmings BA, Cetin I, Charnock-Jones DS, Burton GJ. Evidence of placental translation inhibition and endoplasmic reticulum stress in the etiology of human intrauterine growth restriction. Am J Pathol. 2008 Aug;173(2):451-62. doi: 10.2353/ajpath.2008.071193. Epub 2008 Jun 26.

  PMID: 18583310 BACKGROUND

• Kent EM, Breathnach FM, Gillan JE, McAuliffe FM, Geary MP, Daly S, Higgins JR, Hunter A, Morrison JJ, Burke G, Higgins S, Carroll S, Dicker P, Manning F, Tully E, Malone FD. Placental pathology, birthweight discordance, and growth restriction in twin pregnancy: results of the ESPRiT Study. Am J Obstet Gynecol. 2012 Sep;207(3):220.e1-5. doi: 10.1016/j.ajog.2012.06.022. Epub 2012 Jul 25.

  PMID: 22835491 BACKGROUND

• Zhang GL, He ZM, Shi XM, Gou CY, Gao Y, Fang Q. Discordant HIF1A mRNA levels and oxidative stress in placental shares of monochorionic twins with selective intra-uterine growth restriction. Placenta. 2015 Mar;36(3):297-303. doi: 10.1016/j.placenta.2014.12.019. Epub 2014 Dec 30.

  PMID: 25573093 BACKGROUND

• Schrey S, Kingdom J, Baczyk D, Fitzgerald B, Keating S, Ryan G, Drewlo S. Leptin is differentially expressed and epigenetically regulated across monochorionic twin placenta with discordant fetal growth. Mol Hum Reprod. 2013 Nov;19(11):764-72. doi: 10.1093/molehr/gat048. Epub 2013 Jul 4.

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• Liao TB, Nomura RM, Liao AW, Francisco RP, Zugaib M. Fetal venous circulation in monochorionic twin pregnancies with placental insufficiency: prediction of acidemia at birth or intrauterine fetal death. Ultrasound Obstet Gynecol. 2014 Apr;43(4):426-31. doi: 10.1002/uog.12549. Epub 2014 Mar 12.

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• Levine D, Zuo C, Faro CB, Chen Q. Potential heating effect in the gravid uterus during MR HASTE imaging. J Magn Reson Imaging. 2001 Jun;13(6):856-61. doi: 10.1002/jmri.1122.

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Related Links

• Study website

Biospecimen

Retention: SAMPLES WITH DNA

placental samples

Study Officials

• Liesbeth Lewi

  UZ Leuven

  STUDY CHAIR

Central Study Contacts

Isabel Couck

CONTACT

+32 16 34 22 94; isabel.couck@uzleuven.be

Liesbeth Lewi

CONTACT

liesbeth.lewi@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 19, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

BE (1)