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出境医 / 临床实验 / Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies:A RCT Study (MWAvsRFA)

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

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Twin; Complicating Pregnancy Microwave Ablation Procedure: Microwave ablation Procedure: Radiofrequency ablation Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The statistician will seal the randomisation codes in sequentially numbered opaque envelopes and send them to the research centres. Allocation will be concealed until participants sign the informed consent, at which time the interventionalist will access the allocation code.
Primary Purpose: Treatment
Official Title: Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Severe Complicated Monochorionic Pregnancies in the Peking University Third Hospital : A Pilot Randomised Controlled Trial
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. Neonatal survival rate [ Time Frame: a month after delivery ]
    The proportion of live births at 28 days postpartum


Secondary Outcome Measures :
  1. Surgical injury to fetal [ Time Frame: at 28 weeks gestation ]
    Using MRI to assess postoperative thermal injury and nerve injury of fetus

  2. Postoperative complications [ Time Frame: at delivery ]
    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

  3. Perinatal outcomes [ Time Frame: a week after delivery ]
    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)

  4. Growth of the children [ Time Frame: 6 months postpartum ]
    The height of the surviving fetus at 6 months


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100083
Sponsors and Collaborators
Peking University Third Hospital
Peking University
Investigators
Layout table for investigator information
Study Chair: Zeng Lin, Ph.D PRS administrator
Tracking Information
First Submitted Date  ICMJE June 22, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
Neonatal survival rate [ Time Frame: a month after delivery ]
The proportion of live births at 28 days postpartum
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Surgical injury to fetal [ Time Frame: at 28 weeks gestation ]
    Using MRI to assess postoperative thermal injury and nerve injury of fetus
  • Postoperative complications [ Time Frame: at delivery ]
    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
  • Perinatal outcomes [ Time Frame: a week after delivery ]
    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)
  • Growth of the children [ Time Frame: 6 months postpartum ]
    The height of the surviving fetus at 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies:A RCT Study
Official Title  ICMJE Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Severe Complicated Monochorionic Pregnancies in the Peking University Third Hospital : A Pilot Randomised Controlled Trial
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The statistician will seal the randomisation codes in sequentially numbered opaque envelopes and send them to the research centres. Allocation will be concealed until participants sign the informed consent, at which time the interventionalist will access the allocation code.
Primary Purpose: Treatment
Condition  ICMJE
  • Twin; Complicating Pregnancy
  • Microwave Ablation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Microwave ablation group
    Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies
    Intervention: Procedure: Microwave ablation
  • Active Comparator: Radiofrequency ablation group
    Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies
    Intervention: Procedure: Radiofrequency ablation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
30
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014452
Other Study ID Numbers  ICMJE PekingUTHweiyuanRCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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
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.
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Peking University
Investigators  ICMJE
Study Chair: Zeng Lin, Ph.D PRS administrator
PRS Account Peking University Third Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP