Fetal DistressNCT06608654
Application of Electronic Endoscope in Fetal Distress
A study testing endoscope application in people with Fetal Distress and Fetal Hypoxia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Fetal distress is a common emergency in obstetrics, which refers to the combined symptoms of fetal health and life in utero due to acute or chronic hypoxia, with an incidence of 2.7% to 38.5%. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress, Fetal Hypoxia
- What is being tested?
- endoscope application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 25 Aug 2026
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 20-45 years with single pregnancy;
- Intrauterine fetal distress occurs during labor (during the first stage of labor), and the fetal membrane was already broken;
- Fetal heart monitoring category II, after stopping oxytocin, oxygen inhalation, change of position, intravenous fluid and other measures can not improve;
- Understand the research procedures, be able to follow the procedures of the research protocol, and voluntarily sign a written consent.
Who cannot join
- Type III fetal heart monitoring for pregnant women who require emergency c-section
- Pregnant women with GBS positive
- Pregnant women suspected of chorioamniotic infection
- Pregnant women have signs of reproductive system infection (vaginal inflammation, cervicitis, uterine infection)
- Pregnant women suspected of uterine rupture
- Pregnant women with abnormal contractions: excessive strong contractions
- Check the fetus for serious deformities during pregnancy
- Check pregnant women with serious abnormal functions of cardiovascular system, urinary system, digestive system, reproductive system and other organs
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: The New Application of Electronic Endoscope in the Visual Diagnosis and Treatment of Intrauterine Fetal Distress During Labor
Fetal distress is a common emergency in obstetrics, which refers to the combined symptoms of fetal health and life in utero due to acute or chronic hypoxia, with an incidence of 2.7% to 38.5%. Fetal distress is mainly related to abnormal amniotic fluid, umbilical cord entanglement and compression, which is an important reason for the increase of cesarean section rate during delivery. At present, the diagnosis of fetal distress mainly relies on electronic monitoring of fetal heart, and the false positive rate is high. Intrauterine pressure catheter has not been widely used because of the little effect of intrauterine treatment and the increase of infection. Endoscopy has been widely used in the diagnosis and treatment of various specialties at present, but the diagnosis and treatment during childbirth are still in a blind area. The characteristics of endoscopic visualization provide a new idea for the diagnosis and treatment of fetal distress during delivery, especially for the etiological diagnosis and treatment of umbilical cord factors. The use of intraauterine endoscope during delivery can make up for the defects of intrauterine pressure catheter, realize the visual diagnosis of the causes of fetal distress such as oligoamniotic fluid, meconium contamination of amniotic fluid, umbilical cord compression caused by entangling and true junction, etc. At the same time, it can also improve the intrauterine environment by perfusion of saline for the causes of fetal embarrassment, correct fetal distress, and extend the observation time during labor. It is beneficial to reduce caesarean section during labor.
- Conditions
- Fetal Distress, Fetal Hypoxia
- Being tested
- endoscope application
- Medical subject headings
- Fetal Distress, Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscope applicationDevice
Intrauterine bronchoscopy application for fetal distress during labor
| Study group | Role | What they receive |
|---|---|---|
| fetal distress | Experimental | Not described Receives: Device: endoscope application |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal distress rate
fetal distress rate during first stage of labor
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
vaginal delivery rate
baby was deliverd vaginally
Measured: through study completion, an average of 1 year
Incidence of maternal infection
materna infection was diagnozed up to 42 days after delivery
Measured: through study completion, an average of 1 year
Neonatal asphyxia rate
Neonatal asphyxia was diagnozed after the baby was deliverd
Measured: through study completion, an average of 1 year
neonatal NICU admission rate
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Taixing People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608654
- Sponsor's protocol ID
- EEFD-01
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Application of Electronic Endoscope in the Visual Diagnosis and Treatment of Intrauterine Fetal Distress During Labor
- ClinicalTrials.gov ID
- NCT06608654
- Acronym / sponsor ID
- EEFD-01
- Conditions
- Fetal Distress, Fetal Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Taixing People's Hospital
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
Fetal distress is a common emergency in obstetrics, which refers to the combined symptoms of fetal health and life in utero due to acute or chronic hypoxia, with an incidence of 2.7% to 38.5%. Fetal distress is mainly related to abnormal amniotic fluid, umbilical cord entanglement and compression, which is an important reason for the increase of cesarean section rate during delivery. At present, the diagnosis of fetal distress mainly relies on electronic monitoring of fetal heart, and the false positive rate is high. Intrauterine pressure catheter has not been widely used because of the little effect of intrauterine treatment and the increase of infection. Endoscopy has been widely used in the diagnosis and treatment of various specialties at present, but the diagnosis and treatment during childbirth are still in a blind area. The characteristics of endoscopic visualization provide a new idea for the diagnosis and treatment of fetal distress during delivery, especially for the etiological diagnosis and treatment of umbilical cord factors. The use of intraauterine endoscope during delivery can make up for the defects of intrauterine pressure catheter, realize the visual diagnosis of the causes of fetal distress such as oligoamniotic fluid, meconium contamination of amniotic fluid, umbilical cord compression caused by entangling and true junction, etc. At the same time, it can also improve the intrauterine environment by perfusion of saline for the causes of fetal embarrassment, correct fetal distress, and extend the observation time during labor. It is beneficial to reduce caesarean section during labor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fetal distress | Experimental | Device: endoscope application |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged 20-45 years with single pregnancy;
- Intrauterine fetal distress occurs during labor (during the first stage of labor), and the fetal membrane was already broken;
- Fetal heart monitoring category II, after stopping oxytocin, oxygen inhalation, change of position, intravenous fluid and other measures can not improve;
- Understand the research procedures, be able to follow the procedures of the research protocol, and voluntarily sign a written consent.
Key exclusion criteria (8 listed)
- Type III fetal heart monitoring for pregnant women who require emergency c-section
- Pregnant women with GBS positive
- Pregnant women suspected of chorioamniotic infection
- Pregnant women have signs of reproductive system infection (vaginal inflammation, cervicitis, uterine infection)
- Pregnant women suspected of uterine rupture
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 |
|---|---|---|
| endoscope applicationIntrauterine bronchoscopy application for fetal distress during labor | Device | fetal distress |
Primary outcome
fetal distress rate
Time frame: through study completion, an average of 1 year
fetal distress rate during first stage of labor
4 secondary outcomes
vaginal delivery rate
Time frame: through study completion, an average of 1 year
Incidence of maternal infection
Time frame: through study completion, an average of 1 year
Neonatal asphyxia rate
Time frame: through study completion, an average of 1 year
neonatal NICU admission rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscope application in people with Fetal Distress and Fetal Hypoxia, run by The First Affiliated Hospital with Nanjing Medical University 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 8 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 23 Sep 2024. 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?
fetal distress rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.