Observing placental sharing in monochorionic twins

Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study to Investigate Prediction and Outcome: the TWINSHARE Study

This study looks at how sharing a placenta affects the health of monochorionic twins during pregnancy and their development after birth.

Quick facts

• Study type: Observational
• Enrollment: 393 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 1 site (Leuven)
• Trial ID: NCT03024918 on ClinicalTrials.gov

What this trial studies

This observational study focuses on three cohorts of monochorionic diamniotic twins to evaluate the predictability of unequal placental sharing during pregnancy and its impact on pregnancy outcomes. Serial ultrasounds will be conducted throughout the pregnancy, with MRI offered once, and placental examinations performed post-delivery. The study aims to correlate placental sharing with risks of fetal or neonatal loss, particularly in cases of twin-to-twin transfusion syndrome and selective intra-uterine growth restriction. Additionally, neurological outcomes will be assessed at two years of age for all participants.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 or older with ongoing monochorionic diamniotic twin pregnancies between 11 and 14 weeks.

Not a fit: Patients with singleton pregnancies or those with non-monochorionic twin pregnancies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management and outcomes of pregnancies involving monochorionic twins by identifying risks associated with unequal placental sharing.

How similar studies have performed: While the approach is observational, similar studies have indicated that understanding placental sharing dynamics can lead to better clinical outcomes, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (RECRUITING)

Study contacts

• Study coordinator: Isabel Couck

Conditions: Monochorionic Twins, monochorionic, placental sharing