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NCT Number: NCT03024918

Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

Location status: Recruiting

Location contact

Isabe Couck

CONTACT

Liesbeth Lewi

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Couck

CONTACT

[email protected]

+32 16 34 22 94

Liesbeth Lewi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: TWINSHARE

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2017
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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