Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study
NCT ID: NCT03024918
Last Updated: 2024-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
393 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-04-30
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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In all cohorts, serial ultrasound will be performed during pregnancy. MRI will be offered once during pregnancy. After delivery, placental examination will be performed.
In unselected MCDA twins, the investigators will assess the relationship between unequal placental sharing and the risk of fetal or neonatal loss. The investigators will also establish whether umbilical vein measurements or MRI can be used to predict placental sharing.
In cases complicated by twin-to-twin transfusion syndrome (TTTS), the investigators will look at the association between unequal placental sharing and intrauterine fetal demise after laser surgery.
In cases complicated by selective intra-uterine growth restriction (sIUGR), the the relationship between unequal placental sharing and the risk of fetal or neonatal loss and birth prior to 34 weeks will be assessed.
Furthermore, data on neurological outcome at 2 years of age in all cohorts will be collected.
In unselected MCDA twins, the investigators will assess the relationship between unequal placental sharing and the risk of fetal or neonatal loss. The investigators will also establish whether umbilical vein measurements or MRI can be used to predict placental sharing.
In cases complicated by twin-to-twin transfusion syndrome (TTTS), the investigators will look at the association between unequal placental sharing and intrauterine fetal demise after laser surgery.
In cases complicated by selective intra-uterine growth restriction (sIUGR), the the relationship between unequal placental sharing and the risk of fetal or neonatal loss and birth prior to 34 weeks will be assessed.
Furthermore, data on neurological outcome at 2 years of age in all cohorts will be collected.
Conditions
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Monochorionic Twins
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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MCDA cohort
Unselected monochorionic diamniotic (MCDA) twin pregnancies, included between 11 and 14 weeks of gestation
No interventions assigned to this group
TTTS cohort
Pregnancies complicated by twin-twin transfusion syndrome (TTTS) undergoing laser treatment, included at the time of diagnosis or referral
No interventions assigned to this group
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%.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Age \< 18 years
* Inability to consent
* Inability to consent
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Liesbeth Lewi
Role: STUDY_CHAIR
UZ Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Site Status
RECRUITING
Countries
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Belgium
Central Contacts
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Facility Contacts
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Isabe Couck
Role: primary
Liesbeth Lewi
Role: backup
References
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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.
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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.
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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.
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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.
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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.
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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.
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Related Links
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http://www.monochorionictwins.org
Study website
Other Identifiers
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S5877
Identifier Type: -
Identifier Source: org_study_id
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