Monochorionic TwinsTWINSHARENCT03024918
Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study
An observational study of Monochorionic Twins, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Monochorionic Twins
- How many people
- 393 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Dec 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Age < 18 years
- Inability to consent
Trial locations and contacts
1 site in 1 country.
Liesbeth Lewi contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Isabe Couck
Liesbeth Lewi
About this study
Official title: Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study to Investigate Prediction and Outcome: the TWINSHARE Study
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.
Read the detailed description
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.
- Conditions
- Monochorionic Twins
- Keywords
- monochorionic, placental sharing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCDA cohort: the association between unequal sharing and risk of fetal or neonatal loss (assessed by review of obstetric and pediatric records)
Measured: 2 weeks after expected date of birth
TTTS cohort: the association between unequal sharing and intrauterine fetal death (assessed by review of obstetric records)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 years after expected date of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Monochorionic TwinsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth Lewi, Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024918
- Sponsor's protocol ID
- S5877
- Acronym
- TWINSHARE
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2017
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18533114Lewi 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.
PubMed 18539257Cavicchioni 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.
PubMed 16579799Lopriore 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.
PubMed 17306663Lopriore 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.
PubMed 22197628Aston 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.
PubMed 18577552Lewi 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.
PubMed 23103301Kent 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.
PubMed 21864823Monk 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.
PubMed 26428495Su 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.
PubMed 26428491Su 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.
PubMed 25343232Gratacos 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.
PubMed 17542039Ishii 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.
PubMed 19864880Gratacos 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.
PubMed 15287053Peeva 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.
PubMed 25896405
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study to Investigate Prediction and Outcome: the TWINSHARE Study
- ClinicalTrials.gov ID
- NCT03024918
- Acronym / sponsor ID
- TWINSHARE / S5877
- Conditions
- Monochorionic Twins
- Keywords
- monochorionic, placental sharing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (15 listed)
- MCDA cohort
- TTTS cohort
- sIUGR cohort
Key exclusion criteria (2 listed)
- Age < 18 years
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MCDA cohort: the association between unequal sharing and risk of fetal or neonatal loss (assessed by review of obstetric and pediatric records)
Time frame: 2 weeks after expected date of birth
TTTS cohort: the association between unequal sharing and intrauterine fetal death (assessed by review of obstetric records)
Time frame: 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)
Time frame: 2 weeks after expected date of birth
2 secondary outcomes
The correlation between prenatal ultrasound and MRI variables and placental sharing as assessed by postnatal imaging (all cohorts)
Time frame: 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)
Time frame: 2 years after expected date of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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 18539257Lewi 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.
- Background: PubMed 16579799Cavicchioni 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.
- Background: PubMed 17306663Lopriore 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.
- Background: PubMed 22197628Lopriore 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.
- Background: PubMed 18577552Aston 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.
- Background: PubMed 23103301Lewi 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.
- Background: PubMed 21864823Kent 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.
- Background: PubMed 26428495Monk 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.
- Background: PubMed 26428491Su 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.
- Background: PubMed 25343232Su 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.
- Background: PubMed 17542039Gratacos 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.
- Individual participant dataSharing planned: Undecided
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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.
Liesbeth Lewi contact
Liesbeth Lewi study chair
UZ Leuven
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 Monochorionic Twins, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 15 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Couck (+32 16 34 22 94, isabel.couck@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCDA cohort: the association between unequal sharing and risk of fetal or neonatal loss (assessed by review of obstetric and pediatric records) (time frame: 2 weeks after expected date of birth). The study lists 3 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 NCT03024918, which also lists 31 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 10 Jul 2024.