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RecruitingNCT07124312Updated Aug 15, 2025

Placental Characteristics Within Monochorionic Twin Pregnancies

An observational study in Placenta, Monochorionic Twins and Anatomy, sponsored by Birmingham Women's NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Birmingham Women's NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta
  • Monochorionic Twins
  • Anatomy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Singleton, dichorionic and higher order pregnancies (e.g. triplet).
  • Fetus with known major congenital anomalies or aneuploidy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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 years

  3. 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)

  5. 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.

    To examine the impact of placenta position during laser ablation for twin-twin transfusion syndrome on the frequency of post-laser residual anastomoses. Placenta position will be either anterior or posterior 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)

  6. The influence of intertwin cord distance on fetal complications

    The assess the intercord twin distance on fetal complications such birthweight discordance. The distance of the twin cords will be measured in centimetres. This distance will be divided by the distance of the overall placental length to form a number between 0-1. This will then be compared graphically against birthweight discordance, which will be presented as a percentage (difference between the larger twin weight and smaller twin weight, divided by the larger twin weight).

    Time frame: Throughout the study period (approximately 2 years)

  7. Determine the frequency of abnormal cord insertion in monochorionic twin groups

    To determine the frequencies of abnormal cord insertion (velamentous and marginal) in monochorionic twin groups. This will be defined as percentages (number of cases with abnormal cord (velamentous, marginal and both) divided by the overall number) in each twin group (uncomplicated, twin-twin transfusion, selective growth restriction, twin anaemia-polycythaemia, TRAP, monoamniotic). Results will be compared to each group using P values.

    Time frame: Throughout the study period (approximately 2 years)

  8. Determine the frequency of intertwin anastomoses in monochorionic twin groups

    To determine the frequencies of intertwin vascular anastomoses (overall, artery-artery, artery-vein, vein-vein) in monochorionic twin groups. This will be defined as percentages (number of cases with intertwin vascular anastomoses (overall, artery-artery, artery-vein, vein-vein) divided by the overall number in each twin group (uncomplicated, twin-twin transfusion, selective growth restriction, twin anaemia-polycythaemia, TRAP, monoamniotic). Results will be compared to each group using P values

    Time frame: Throughout the study period (approximately 2 years)

06

Study locations

1 of 1 sites recruiting
  • Birmingham Women's and Children's NHS Foundation Trust
    Birmingham, West Midlands B15 2TG, United Kingdom
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07124312
Lead sponsor
Birmingham Women's NHS Foundation Trust
Responsible party
Jack Hamer (Clinical research fellow, Birmingham Women's NHS Foundation Trust) — Principal investigator
First posted
Aug 15, 2025
Start date
Dec 12, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Aug 15, 2025

Study contacts

Jack Hamer, MBChB
Contact
jack.hamer1@nhs.net
0121 472 1377
Jack Hamer, MBChB
principal investigator · Birmingham Women's and Children's NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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