Monochorionic Twins Clinical Trial
— TWINSHAREOfficial 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.
| Status | Recruiting |
| Enrollment | 393 |
| Est. completion date | December 2020 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 Exclusion Criteria: - Age < 18 years - Inability to consent |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
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* Note: There are 31 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | TTTS cohort: the association between unequal sharing and intrauterine fetal death (assessed by review of obstetric records) | 2 weeks after expected date of birth | ||
| Primary | 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 | 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 | ||
| Secondary | 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 |