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Status unknownNCT06608654Updated Sep 23, 2024

Application of Electronic Endoscope in Fetal Distress

An interventional study of endoscope application in Fetal Distress and Fetal Hypoxia, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Female
01

Study 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%. 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.

02

Conditions studied

  • Fetal Distress
  • Fetal Hypoxia
03

In context

Fetal Distress

36 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.

This study's planned enrollment of 15 is below the median of 110 across 25 interventional studies indexed under Fetal Distress.

Browse Fetal Distress studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 564 studies on the registry; 312 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects aged 20-45 years with single pregnancy;
  2. Intrauterine fetal distress occurs during labor (during the first stage of labor), and the fetal membrane was already broken;
  3. Fetal heart monitoring category II, after stopping oxytocin, oxygen inhalation, change of position, intravenous fluid and other measures can not improve;
  4. Understand the research procedures, be able to follow the procedures of the research protocol, and voluntarily sign a written consent.

Exclusion criteria

Exclusion Criteria:

  1. Type III fetal heart monitoring for pregnant women who require emergency c-section
  2. Pregnant women with GBS positive
  3. Pregnant women suspected of chorioamniotic infection
  4. Pregnant women have signs of reproductive system infection (vaginal inflammation, cervicitis, uterine infection)
  5. Pregnant women suspected of uterine rupture
  6. Pregnant women with abnormal contractions: excessive strong contractions
  7. Check the fetus for serious deformities during pregnancy
  8. Check pregnant women with serious abnormal functions of cardiovascular system, urinary system, digestive system, reproductive system and other organs
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    fetal distress

    Device: endoscope application

Interventions

  • Deviceendoscope application

    Intrauterine bronchoscopy application for fetal distress during labor

06

What researchers measure

Primary outcomes

  1. fetal distress rate

    fetal distress rate during first stage of labor

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. vaginal delivery rate

    baby was deliverd vaginally

    Time frame: through study completion, an average of 1 year

  2. Incidence of maternal infection

    materna infection was diagnozed up to 42 days after delivery

    Time frame: through study completion, an average of 1 year

  3. Neonatal asphyxia rate

    Neonatal asphyxia was diagnozed after the baby was deliverd

    Time frame: through study completion, an average of 1 year

  4. neonatal NICU admission rate

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06608654
Collaborators
Taixing People's Hospital
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Aug 25, 2025 (estimated)
Completion
Aug 25, 2026 (estimated)
Last update
Sep 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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