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

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ClinicalTrials.gov Identifier: NCT03024918
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease
Monochorionic Twins

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.

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Study Type : Observational
Estimated Enrollment : 393 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study to Investigate Prediction and Outcome: the TWINSHARE Study
Study Start Date : April 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2020

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%.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
placental samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024918


Contacts
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Contact: Isabel Couck +32 16 34 22 94 isabel.couck@uzleuven.be
Contact: Liesbeth Lewi liesbeth.lewi@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium
Contact: Isabe Couck         
Contact: Liesbeth Lewi         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Study Chair: Liesbeth Lewi UZ Leuven
Additional Information:
Publications:

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03024918    
Other Study ID Numbers: S5877
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Universitaire Ziekenhuizen Leuven:
monochorionic
placental sharing