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

Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Severe Complicated Monochorionic Pregnancies in the Peking University Third Hospital : A Pilot Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Microwave Ablation; Twin; Complicating Pregnancy
• Intervention / Treatment: Procedure: Microwave ablation; Procedure: Radiofrequency ablation

Detailed Description

Medical charts were reviewed for the details of surgery and the pregnancy outcomes if the patient delivered at the authors'institution. In the event of delivery at distant locations, patients were contacted by telephone to obtain delivery and neonatal information. Patients are randomly assigned 1:1 to different intervention groups by parallel design. Chorionicity was assessed by the referring physicians during the first trimester. All patients underwent comprehensive ultrasound examination to confirm the fetal diagnosis, chorionicity, amnionicity and cervical length upon arrival at Peking University Third Hospital. Monochorionicity was confirmed through the ultrasound findings of a single placenta, a thin intervening membrane, lack of a lambda sign and concordance for fetal gender. Patients were counseled about the risks and benefits of expectant management vs. selective reduction. Written informed consent was obtained. Statistical analysis was performed using the statistical software Statistical Product and Service Solutions(SPSS), for comparison of entry and outcome variables using the chi-square test, Fisher's exact test and the Student's t-test, where appropriate. P < 0.05 was considered as statistically significant.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100083
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Complicated monochorionic pregnancies women;
2. Having the indication of selective reduction;(TTTS III or IV, TRAP, severe sIUGR, Twin malformation inconsistency or stillbirth，three or more fetuses with monochorionic pregnancies requiring reducing the number of fetuses）
3. The reduction surgery should be done after 15 weeks of gestation;
4. Willingness to participate in the trial and having provided written consent.

Exclusion Criteria:

1. Preoperative examination shows that patient is not appropriate to undergoing reduction surgery, such as acute infection of the organ system, especially the urinary system.
2. Patients need to perform acute reduction surgery due to the progress of the disease and the surgery cannot be scheduled.
3. Other diseases that may affect the experimental results: neuropsychiatric diseases and congenital diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave ablation group; Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies	Procedure: Microwave ablation; Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
Active Comparator: Radiofrequency ablation group; Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies	Procedure: Radiofrequency ablation; Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal survival rate	The proportion of live births at 28 days postpartum	a month after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical injury to fetal	Using MRI to assess postoperative thermal injury and nerve injury of fetus	at 28 weeks gestation
Postoperative complications	Frequency of PPROM, premature delivery, frequency of infection, procedure-to-delivery interval, <28 weeks of intrauterine fetal death/abortion, >28 weeks of intrauterine fetal deat and <32 weeks premature delivery	at delivery
Perinatal outcomes	Using Apgar Score to assess neonatal asphyxia（Heart rate, respiration, muscle tone, laryngeal reflex and skin color within one minute after birth are taken as the basis, each item is 0~2 points, the full mark is 10 points. 8~10 belong to normal newborns. 4~7 can be classified as mild asphyxiation, 0~3 as severe asphyxiation）	a week after delivery
Growth of the children	The height of the surviving fetus at 6 months	6 months postpartum

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking University
• Investigators: Study Chair: Zeng Lin, Ph.D, PRS administrator

Publications and helpful links

General Publications

• Xie J, Cheng Z, Wu T, Wei Y, Wang X. Microwave ablation versus radiofrequency ablation for the treatment of severe complicated monochorionic pregnancies in China：protocol for a pilot randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e034995. doi: 10.1136/bmjopen-2019-034995.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: June 22, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Complicated Monochorionic Pregnancies; Selective feticide
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: PekingUTHweiyuanRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Requested data for public purpose or research transparency will be provided via the corresponding author. Participant data after deidentification (text, table, figures, and appendices) and protocol will be shared beginning 9 months and ending 36 months following article publication
• IPD Sharing Time Frame: Participant data after deidentification (text, table, figures, and appendices) and protocol will be shared beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Requested data for public purpose or research transparency will be provided via the corresponding author.The e-mail address is weiyuanbysy@163.com.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No