NCT07124312

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Dec 2024Feb 2027

Study Start

First participant enrolled

December 12, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 1, 2025

Last Update Submit

August 8, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    Throughout the study period (approximately 2 years)

  • 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

    Throughout the study period (approximately 2 years

  • 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.

    Throughout the study period (approximately 2 years)

Secondary Outcomes (8)

  • The influence of abnormal cord insertion in monochorionic twins complicated by twin-twin transfusion syndrome

    Throughout the study period (approximately 2 years)

  • The influence of residual vascular anastomoses monochorionic twins complicated by twin-twin transfusion syndrome

    Throughout the study period (approximately 2 years)

  • The influence of abnormal cord insertion on residual anastomoses development in monochorionic twins complicated by twin-twin transfusion syndrome undergoing laser ablation

    Throughout the study period (approximately 2 years)

  • Examine the association between Quintero staging during laser ablation for monochorionic twins complicated by twin-twin transfusion syndrome on residual anastomoses development

    Throughout the study period (approximately 2 years)

  • Examine the relationship between placenta position during laser ablation for monochorionic twins complicated by twin-twin transfusion syndrome and the rate of residual anastomoses development.

    Throughout the study period (approximately 2 years)

  • +3 more secondary outcomes

Study Arms (2)

Uncomplicated monochorionic twins

Monochorionic twins which do not develop any complications during the antenatal period

Complicated monochorionic twins

Monochorionic twins which develop any type of complication during the antenatal period such as TTTS, sIUGR and TAPS.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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).

You may qualify if:

  • All consecutive placentas of monochorionic twin pregnancies whereby the placenta is transferred to the pathology department for analysis.

You may not qualify if:

  • Singleton, dichorionic and higher order pregnancies (e.g. triplet).
  • Fetus with known major congenital anomalies or aneuploidy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, West Midlands, B15 2TG, United Kingdom

RECRUITING

Study Officials

  • Jack Hamer, MBChB

    Birmingham Women's and Children's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Hamer, MBChB

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical research fellow

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 15, 2025

Study Start

December 12, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations