Developing a non-invasive treatment for twin-twin transfusion syndrome

Not Applicable

• Conditions: Twin-twin transfusion syndrome; Neonatal Diseases; Fetus and newborn affected by placental transfusion syndromes

• Registration Number: ISRCTN33458649
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-05
• Last Update Posted: 10 June 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

1. Able to understand patient information sheet (with appropriate support/interpretation if required) and give informed consent
2. Women currently pregnant with monochorionic diamniotic twin pregnancies
3. Gestational age between 12+0 and 17+6 weeks at time of USgHIFU treatment
4. Pregnancy diagnosed with TTTS Stage I-IV (Quintero staging)
5. Aged 18 years or more
6. Enrolled in the Investigating the feasibility of using Doppler ultrasound imaging to map placental vasculature and anastomoses in monochorionic diamniotic (MCDA) twin pregnancies, IRAS 242564 (twin placental mapping) study

Exclusion Criteria

1. Maternal age 51 years or more (average age of menopause in the UK)
2. Pregnancy diagnosed with TTTS Stage V (one or both fetuses dead)
3. Chorionicity assigned at > 14+0 weeks
4. Higher-order pregnancy (even if containing MCDA pair)
5. BMI >35
6. Significant abdominal scarring, subject to medical assessment
7. Unable or unwilling to travel to London for treatment and follow-up
8. Placental anastomoses cannot be identified with ultrasound
9. USgHIFU treatment cannot be planned for technical reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety: Number/rate of patients experiencing significant iatrogenic harm, measured using clinical examination, review of participant medical records and/or patient symptom diaries, daily for first 14 days after HIFU treatment completed (clinical examination and/or symptom diaries) and after delivery (participant medical records)<br>2. Efficacy: Number/rate of targeted placental anastomoses which appear occluded at the end of a HIFU treatment cycle, assessed using comparison of colour Doppler imaging of target anastomoses pre- and post-HIFU exposure