Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study (TWINSHARE)

January 19, 2017 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

393

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Contact:
          • Liesbeth Lewi
        • Contact:
          • Isabe Couck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 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
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 weeks after expected date of birth

Secondary Outcome Measures

Outcome Measure
Time Frame
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 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
2 years after expected date of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Study Chair: Liesbeth Lewi, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S5877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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