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 |
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Twin; Complicating Pregnancy Microwave Ablation | Procedure: Microwave ablation Procedure: Radiofrequency ablation | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Microwave ablation group
Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies
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Procedure: Microwave ablation
Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
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Active Comparator: Radiofrequency ablation group
Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies
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Procedure: Radiofrequency ablation
Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Beijing | |
Peking University Third Hospital | |
Beijing, Beijing, China, 100083 |
Study Chair: | Zeng Lin, Ph.D | PRS administrator |
Tracking Information | |||||||||||||||||
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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 |
Neonatal survival rate [ Time Frame: a month after delivery ] The proportion of live births at 28 days postpartum
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
60 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Peking University Third Hospital | ||||||||||||||||
Study Sponsor ICMJE | Peking University Third Hospital | ||||||||||||||||
Collaborators ICMJE | Peking University | ||||||||||||||||
Investigators ICMJE |
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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 |