Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies：A RCT Study

Summary

Complicated pregnancies refer some special complications, including twin to twin transfusion syndrome(TTTS), twin reverse arterial perfusion(TRAP), selective intrauterine fetal growth restriction(sIUGR), twin anemia-polycythemia sequence(TAPS), one fetal death or structural abnormalities, etc. Complicated twins are often associated with high perinatal morbidity and mortality. Severe complicated twins can be treated with fetal-reduction surgery during pregnancy, which can improve the survival rate of retained fetuses and reduce the disability rate. The managements include mechanical umbilical cord ligation or thermal coagulation obliteration, such as bipolar coagulation (BCC), radiofrequency ablation (RFA), and laser coagulation.Nowadays radiofrequency ablation reduction is the most common, which processes a higher survival rate and fewer maternal and fetal complications compared with other ways.Latest experience suggests that microwave ablation(MWA) is also easy to be used and the therapeutic effect is similar with RFA, but there is no convincing evidence. Compared with radiofrequency ablation, MWA has the advantages of simple operation and time, and avoids the problems of tissue carbonization, drying and heat sink effect. For fetation reduction surgery, the main advantage is that the endothermic effect near the blood vessels is smaller, which enables microwave fetation reduction to have a larger ablation range and a higher thermal effect. This study is comparing Microwave Ablation(MWA) and radiofrequency ablation (RFA) methods for selective fetal reduction in the treatment of complicated monochorionic (MC) multifetal gestations.

This is a pilot randomised controlled trial(RCT) of 60 patients who undergo selective fetal reduction. The subjects of this study were all pregnant women and their offspring who underwent reduction surgery in the third hospital of Beijing University, and patients are randomly assigned 1:1 to different intervention groups by parallel design. The outcome evaluators were blind. Collecting their surgery, clinical information and maternal and fetal complications at a week and a month after surgery, 42 days and 6 months after delivery, to verify the safety and efficacy of MWA, and find a better treatment plan for complicated monochorionic pregnancies .The primary outcome was neonatal survival rate.

Conditions

• Twin; Complicating Pregnancy
• Microwave Ablation

Interventions

PROCEDURE

Microwave ablation

Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.

PROCEDURE

Radiofrequency ablation

Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.

Sponsors & Collaborators

• Peking University

  collaborator OTHER

• Peking University Third Hospital

  lead OTHER

Principal Investigators

• Zeng Lin, Ph.D · PRS administrator

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-15

Primary Completion

2020-10-01

Completion

2020-11-01

Countries

• China

Study Locations