Twin-twin transfusion syndrome Neonatal Diseases Fetus and newborn affected by placental transfusion syndromes
Conditions
Interventions
Design: Phase 1a safety/efficacy (Bryant Day model).
Recruitment:
Potential participants will be identified from:
1. Women booked for obstetric care at Queen Charlotte's and Chelsea Hospital (QCCH),
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility and acceptability of HIFU treatment in terms of study eligibility, recruitment and retention, measured using number of patients who were (i) screened, (ii) recruited and (iii) remained in the study until their delivery at end of the trial period 2. Pregnancy outcomes: 2.1. Rates of regression/persistence/deterioration or recurrence of TTTS measured using Quintero staging at day 1, 3, 7 and 14 after HIFU treatment 2.2. Need for further treatment of TTTS measured using Quintero staging at day 3, 7 and 14 after HIFU treatment 2.3. Pregnancy complications (antepartum bleeding, preterm rupture of membranes, other) measured using review of participant medical records at delivery 2.4. Gestational ages at delivery measured using review of participant medical records at delivery 2.5. Birth weights measured using review of participant medical records at delivery 2.6. Number of live-births measured using review of participant medical records at delivery 3. Placental outcomes: 3.1. Evidence of occlusion of the placenta using photographs of placental surface post-delivery 3.2. Histopathology reports of placenta, if performed, measured using processes adhering to local policy for histopathological placental examination at post-delivery 4. Acceptability of the treatment to participants assessed qualitatively using semi-structured interview and patient diaries at day 1 post HIFU treatment and after delivery | — |
Countries
England, United Kingdom
Outcome results
None listed