Placental Characteristics Within Monochorionic Twin Pregnancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorBirmingham Women's NHS Foundation Trust
About this trial
This prospective study aims to collate a comprehensive database of all main monochorionic twin groups to enable comparisons to be made within each twin group and additionally between each group with regards to several placental characteristics, whilst understanding their impact on several fetal outcomes. This study aims to provide new insights in to how the placental architecture influences pregnancy care within the UK pregnancy cohort. Results of this study may impact how clinicians conduct antenatal surveillance for these anatomical placental factors.
Patients of both uncomplicated and complication monochorionic twin groups will be consented at a single site and recruited during the antenatal period. Following delivery the placenta will then be analysed macroscopically and assessed for several anatomical features. This will be compared with the antenatal complications and perinatal outcomes for the respective twin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Singleton, dichorionic and higher order pregnancies (e.g. triplet).
Fetus with known major congenital anomalies or aneuploidy
Trial population
Placentas received within the pathology department from monochorionic twin groups . These groups include: * Uncomplicated monochorionic twins * Monochorionic twins with complications (e.g. selective intrauterine growth restriction, twin-twin transfusion syndrome , twin anaemia-polycythaemia sequence etc).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
65 Participants
are grouped into 2 trial groupsGroup A: Uncomplicated monochorionic twins
Group B: Complicated monochorionic twins
Trial outcomes
Primary outcomes
1
What is the impact of intertwin vascular anastomoses on fetal complications and perinatal outcome
To determine the prevalence of intertwin vascular anastomoses (overall, artery-artery, artery-vein, vein-vein) on adverse perinatal outcome (e.g. stillbirth and neonatal death) and fetal complications (e.g. small for gestational age). Measures will be as overall percentages and also raw numbers which will be calculated in to odds ratio's when comparing anastomoses versus no anastomoses against the respective perinatal outcome and fetal complication
Time frame
Throughout the study period (approximately 2 years)2
What is the impact of abnormal cord insertion on fetal complications and perinatal perinatal outcome
To determine the prevalence of abnormal cord insertion (marginal and velamentous) on adverse perinatal outcome (e.g. stillbirth and neonatal death) and fetal complications (e.g. small for gestational age, selective growth restriction). Measures will be as overall percentages and also raw numbers which will be calculated in to odds ratio's when comparing abnormal cord insertion versus normal cord insertion against the respective perinatal outcome and fetal complication
Time frame
Throughout the study period (approximately 2 years3
What is the impact of twin placental sharing on fetal complications and perinatal outcome
To determine the impact of placental sharing between each twin on adverse perinatal outcome (e.g. stillbirth and neonatal death) and fetal complications (e.g. birthweight discordance and selective growth restriction). Placental sharing will be defined as a percentage of overall share between each twin which sums up to 100%. The difference between each twin's share will be determine by minimising the larger percentage from the smaller percentage. The difference will then be compared to adverse perinatal outcomes and complications such as selective growth restriction using odds ratio's. Birthweight discordance will be defined as a percentage ( difference between the larger twin weight and smaller twin weight, divided by the larger twin weight). This will be compared to placental sharing using a graphical comparison of all placental sharing results, individually compared against each respective birthweight discordance.
Time frame
Throughout the study period (approximately 2 years)Secondary outcomes
1
The influence of abnormal cord insertion in monochorionic twins complicated by twin-twin transfusion syndrome
To understand the frequency of abnormal cord insertion (marginal and velamentous) within monochorionic twins complicated by twin-twin transfusion syndrome following laser ablation and determine the impact on fetal outcomes such as stillbirth, neonatal death, recurrent twin-twin transfusion syndrome and twin anaemia-polycythaemia sequence. Results will be collected as overall number of placentas with abnormal cord (both marginal, velamentous and both) and those with normal cord insertion, and compared against the number of events in the respective fetal outcome. Results will be presented as odds ratio's.
Time frame
Throughout the study period (approximately 2 years)2
The influence of residual vascular anastomoses monochorionic twins complicated by twin-twin transfusion syndrome
To understand the frequency of residual vascular anastomoses within monochorionic twins complicated by twin-twin transfusion syndrome following laser ablation and determine their impact on fetal outcomes such as stillbirth, neonatal death, recurrent twin-twin transfusion syndrome and twin anaemia-polycythaemia sequence. Results will be collected as overall number of placentas with residual vascular anastomoses, alongside the individual types of anastomoses (artery-artery, artery-vein, vein-vein) and compared against the number of events in the respective fetal outcome. Results will be presented as odds ratio's.
Time frame
Throughout the study period (approximately 2 years)3
The influence of abnormal cord insertion on residual anastomoses development in monochorionic twins complicated by twin-twin transfusion syndrome undergoing laser ablation
To understand the impact of abnormal cord insertion (marginal and velamentous) on residual anastomoses development in monochorionic twins complicated by twin-twin transfusion syndrome undergoing laser ablation. Results will be collected as overall number of placentas with abnormal cord insertion and whether they have residual anastomoses versus those without abnormal cord insertion and if they have residual anastomoses seen. Results will be presented as odds ratio's.
Time frame
Throughout the study period (approximately 2 years)4
Examine the association between Quintero staging during laser ablation for monochorionic twins complicated by twin-twin transfusion syndrome on residual anastomoses development
To examine the impact of Quintero staging during laser ablation for twin-twin transfusion syndrome on the frequency of post-laser residual anastomoses. Quintero staging will be split in to the four stages and expressed as overall numbers versus the number of placentas with and without residual anastomoses. Results will be expressed as odds ratio's.
Time frame
Throughout the study period (approximately 2 years)Sponsors and contacts
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Source ClinicalTrials.gov