Solomon study

Fetoscopic laser coagulation of the entire vascular equator for the treatment of twin-to-twin transfusion syndrome: the "Solomon study"

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23535

Enrollment

184

Registered

2008-03-04

Start date

2008-03-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin-to-twin transfusion syndrome Twin anemia-polycythemia sequence Fetoscopic laser surgery

Interventions

‘Solomon technique’: after identification and coagulation of each individual anastomosis, the complete vascular equator is coagulated from one placental margin to the other. Compared to the ‘Selective

Eligibility

Inclusion criteria

Inclusion criteria: 1. All TTTS pregnancies eligible for laser surgery up to 26 weeks’ gestation.

Exclusion criteria

Exclusion criteria: 1. Triplet pregnancies 2. Language problems for informed consent.

Design outcomes

Primary

Measure	Time frame
Primary outcome measure will be the prevalence of TAPS or recurrence of TTTS. 4-7-2013: An adjustment to the primary outcome and sample size calculation was made after the start of recruitment and was approved by the medical ethics committee (P07.261). The initial primary outcome was reduction of TAPS and recurrent TTTS and sample size was based on a reduction of 15% (20% in the Solomon group versus 5% in the Selective group). Secondary outcomes were perinatal mortality and neonatal morbidity. Since it was of high importance to show that the use of the new treatment modality would not have a negative effect on perinatal mortality and neonatal morbidity, we therefore included perinatal mortality and severe neonatal morbidity in the primary outcome. The expected reduction of the composite outcome of 15%, with 45% in the Solomon group and 60% in the selective group, increased the sample size from 184 to 274 patients.	—

Measure

Time frame

Primary outcome measure will be the prevalence of TAPS or recurrence of TTTS. 4-7-2013: An adjustment to the primary outcome and sample size calculation was made after the start of recruitment and was approved by the medical ethics committee (P07.261). The initial primary outcome was reduction of TAPS and recurrent TTTS and sample size was based on a reduction of 15% (20% in the Solomon group versus 5% in the Selective group). Secondary outcomes were perinatal mortality and neonatal morbidity. Since it was of high importance to show that the use of the new treatment modality would not have a negative effect on perinatal mortality and neonatal morbidity, we therefore included perinatal mortality and severe neonatal morbidity in the primary outcome. The expected reduction of the composite outcome of 15%, with 45% in the Solomon group and 60% in the selective group, increased the sample size from 184 to 274 patients.

—

Secondary

Measure	Time frame
Secondary outcomes include residual anastomoses on placental injection, perinatal mortality and neonatal morbidity.	—

Contacts

Public ContactF. Slaghekke

LUMC, B03-87, Albinusdreef 2

F.Slaghekke@lumc.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)