FetoscopyNCT02434926
Anesthetic Management in Fetoscopic Surgery and Incidence of Complications
An observational study of Fetoscopy and Anesthetic Complications, run by Mahidol University at 2 sites in Thailand.
Trial summary
Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetoscopy, Anesthetic Complications, Pregnancy
- How many people
- 152 participants
- Where
- 2 sitesThailand
- Study dates
- May 2015to Feb 2016
- Phase
- Observational
- 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
Study population: Pregnant women who received fetocsopic surgery for any reasons eg. laser ablation of vessels in twin-twin transfusion syndrome, balloon occlusion in fetal congenital diaphragmatic hernia, fetal bladder outlet obstruction, intrauterine blood transfusion etc.
Who may be able to join
- pregnant women who received intrauterine minimally invasive surgery from the past until 30 Nov 2015
Who cannot join
- pregnant women who received intrauterine minimally invasive surgery which was not anesthetized by anesthesiologist.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, 10700
Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review
Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments into the amniotic cavity under ultrasound guidance. This procedure can be successfully done under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each technique has both advantages and drawbacks.
Several complications related to anesthetic after fetoscopic surgery can occur. For instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively can arise from spinal anesthesia.
The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the tertiary care institute (Siriraj hospital) and incidence of complications which may relate to different anesthetic techniques.
Read the detailed description
The quantity and types of medications using in different anesthetic technique will be gathered including opioid, benzodiazepine, propofol, detail of drugs making fetal paralysis, amount of local anesthetic drug in spinal anesthesia etc. Tocolytic drug will also be recorded eg. terbutaline, nifedipine or magnesium sulfate. These drugs have been generally known that may cause hypotension or pulmonary edema.
In intraoperative period, the investigators emphasize in the incidence of hypotension and other possible complications such as pulmonary aspiration, failed intubation, maternal desaturation or maternal bradycardia. Volume of intravenous fluid administered and amount of irrigation fluid will also be recorded.
Maternal and fetal outcome in recovery room and in postoperative period will be collected.
- Conditions
- Fetoscopy, Anesthetic Complications, Pregnancy
- Keywords
- fetoscopy, fetal surgery, anesthetic complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of anesthetic techniques used in fetoscopic surgery
Type of anesthetic techniques eg. general anesthesia, regional anesthesia, local anesthesia with sedation.
Measured: in operating theatre
Secondary outcomes (3)
Types and quantity of anesthetic medications used
Types and quantity of anesthetic medications used for anesthetize patients in different anesthetic techniques.
Measured: in operating theatre
Incidence of complications
Intraoperative complications eg. failed intubation, aspiration, hypotension from spinal anesthesia, high spinal block, desaturation etc.
Measured: in operating theatre
Incidence of complications
Complications occurring postoperatively include pulmonary edema, fatal death etc.
Measured: after surgery till patients discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionFeb 2016
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 FetoscopyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434926
- Sponsor's protocol ID
- 150/2558(EC2)
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2015
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Nivatpumin P, Pangthipampai P, Jirativanont T, Dej-Arkom S, Triyasunant N, Tempeetikul T. Anesthetic Techniques and Incidence of Complications in Fetoscopic Surgery. J Med Assoc Thai. 2016 May;99(5):602-10.
PubMed 27501618
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Management in Fetoscopic Surgery and Incidence of Complications - A Retrospective Review
- ClinicalTrials.gov ID
- NCT02434926
- Acronym / sponsor ID
- 150/2558(EC2)
- Conditions
- Fetoscopy, Anesthetic Complications, Pregnancy
- Keywords
- fetoscopy, fetal surgery, anesthetic complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments into the amniotic cavity under ultrasound guidance. This procedure can be successfully done under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each technique has both advantages and drawbacks.
Several complications related to anesthetic after fetoscopic surgery can occur. For instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively can arise from spinal anesthesia.
The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the tertiary care institute (Siriraj hospital) and incidence of complications which may relate to different anesthetic techniques.
Detailed description
The quantity and types of medications using in different anesthetic technique will be gathered including opioid, benzodiazepine, propofol, detail of drugs making fetal paralysis, amount of local anesthetic drug in spinal anesthesia etc. Tocolytic drug will also be recorded eg. terbutaline, nifedipine or magnesium sulfate. These drugs have been generally known that may cause hypotension or pulmonary edema.
In intraoperative period, the investigators emphasize in the incidence of hypotension and other possible complications such as pulmonary aspiration, failed intubation, maternal desaturation or maternal bradycardia. Volume of intravenous fluid administered and amount of irrigation fluid will also be recorded.
Maternal and fetal outcome in recovery room and in postoperative period will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who received fetocsopic surgery for any reasons eg. laser ablation of vessels in twin-twin transfusion syndrome, balloon occlusion in fetal congenital diaphragmatic hernia, fetal bladder outlet obstruction, intrauterine blood transfusion etc.
Key inclusion criteria (1 listed)
- pregnant women who received intrauterine minimally invasive surgery from the past until 30 Nov 2015
Key exclusion criteria (1 listed)
- pregnant women who received intrauterine minimally invasive surgery which was not anesthetized by anesthesiologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of anesthetic techniques used in fetoscopic surgery
Time frame: in operating theatre
Type of anesthetic techniques eg. general anesthesia, regional anesthesia, local anesthesia with sedation.
3 secondary outcomes
Types and quantity of anesthetic medications used
Time frame: in operating theatre
Incidence of complications
Time frame: in operating theatre
Incidence of complications
Time frame: after surgery till patients discharge from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 27501618Nivatpumin P, Pangthipampai P, Jirativanont T, Dej-Arkom S, Triyasunant N, Tempeetikul T. Anesthetic Techniques and Incidence of Complications in Fetoscopic Surgery. J Med Assoc Thai. 2016 May;99(5):602-10.
- Individual participant dataSharing planned: Undecided
Related trials for Fetoscopy
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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.
Patchareya Nivatpumin, M.D. principal investigator
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetoscopy and Anesthetic Complications, run by Mahidol University at 2 sites in Thailand.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Type of anesthetic techniques used in fetoscopic surgery (time frame: in operating theatre). 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 NCT02434926, 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 15 Nov 2023.