Twin; Complicating PregnancyMWAvsRFANCT04014452
Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies：A RCT Study
A study testing Microwave ablation and Radiofrequency ablation in people with Twin; Complicating Pregnancy and Microwave Ablation, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Twin; Complicating Pregnancy, Microwave Ablation
- What is being tested?
- Microwave ablation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Complicated monochorionic pregnancies women;
- 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）
- The reduction surgery should be done after 15 weeks of gestation;
- Willingness to participate in the trial and having provided written consent.
Who cannot join
- Preoperative examination shows that patient is not appropriate to undergoing reduction surgery, such as acute infection of the organ system, especially the urinary system.
- Patients need to perform acute reduction surgery due to the progress of the disease and the surgery cannot be scheduled.
- Other diseases that may affect the experimental results: neuropsychiatric diseases and congenital diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
About this study
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
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.
Read the 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.
- Conditions
- Twin; Complicating Pregnancy, Microwave Ablation
- Being tested
- Microwave ablation, Radiofrequency ablation
- Keywords
- Complicated Monochorionic Pregnancies, Selective feticide
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationProcedure or surgery
Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
Radiofrequency ablationProcedure or surgery
Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation group | Experimental | Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies Receives: Procedure: Microwave ablation |
| Radiofrequency ablation group | Active comparator | Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal survival rate
The proportion of live births at 28 days postpartum
Measured: a month after delivery
Secondary outcomes (4)
Surgical injury to fetal
Using MRI to assess postoperative thermal injury and nerve injury of fetus
Measured: 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
Measured: 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）
Measured: a week after delivery
Growth of the children
The height of the surviving fetus at 6 months
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Twin; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Zeng Lin, Ph.D, Study chair, PRS administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014452
- Sponsor's protocol ID
- PekingUTHweiyuanRCT
- Acronym
- MWAvsRFA
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 32792427
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04014452
- Acronym / sponsor ID
- MWAvsRFA / PekingUTHweiyuanRCT
- Conditions
- Twin; Complicating Pregnancy, Microwave Ablation
- Keywords
- Complicated Monochorionic Pregnancies, Selective feticide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation group | Experimental | Procedure: Microwave ablationMicrowave ablation is used for the treatment of Complicated Monochorionic Pregnancies |
| Radiofrequency ablation group | Active comparator | Procedure: Radiofrequency ablationRadiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Complicated monochorionic pregnancies women;
- 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）
- The reduction surgery should be done after 15 weeks of gestation;
- Willingness to participate in the trial and having provided written consent.
Key exclusion criteria (3 listed)
- Preoperative examination shows that patient is not appropriate to undergoing reduction surgery, such as acute infection of the organ system, especially the urinary system.
- Patients need to perform acute reduction surgery due to the progress of the disease and the surgery cannot be scheduled.
- Other diseases that may affect the experimental results: neuropsychiatric diseases and congenital diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationUse of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance. | Procedure or surgery | Microwave ablation group |
| Radiofrequency ablationUse of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance. | Procedure or surgery | Radiofrequency ablation group |
Primary outcome
Neonatal survival rate
Time frame: a month after delivery
The proportion of live births at 28 days postpartum
4 secondary outcomes
Surgical injury to fetal
Time frame: at 28 weeks gestation
Postoperative complications
Time frame: at delivery
Perinatal outcomes
Time frame: a week after delivery
Growth of the children
Time frame: 6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 32792427Xie 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Twin; Complicating Pregnancy
RecruitingObservational study
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Fetal Growth Restriction, Cardiac Remodeling, Ventricular
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
Not yet recruitingObservational study
Prospective Twin Pregnancy Cohort at Montpellier University Hospital
Pregnancy, Twin
Active, not recruitingObservational study
Database of Monochorionic Pregnancies
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeng Lin, Ph.D study chair
PRS administrator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation and Radiofrequency ablation in people with Twin; Complicating Pregnancy and Microwave Ablation, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal survival rate (time frame: a month after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.