Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Inability to consent

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

393 Participants
are grouped into 3 trial groups
Group A: MCDA cohort
Group B: TTTS cohort
Group C: sIUGR cohort

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.