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Application of Electronic Endoscope in Fetal Distress

The New Application of Electronic Endoscope in the Visual Diagnosis and Treatment of Intrauterine Fetal Distress During Labor

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06608654
Enrollment
15
Registered
2024-09-23
Start date
2024-10-01
Completion date
2026-08-25
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Distress, Fetal Hypoxia

Brief 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.

Interventions

DEVICEendoscope application

Intrauterine bronchoscopy application for fetal distress during labor

Sponsors

Taixing People's Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

MeasureTime frameDescription
fetal distress ratethrough study completion, an average of 1 yearfetal distress rate during first stage of labor

Secondary

MeasureTime frameDescription
vaginal delivery ratethrough study completion, an average of 1 yearbaby was deliverd vaginally
Incidence of maternal infectionthrough study completion, an average of 1 yearmaterna infection was diagnozed up to 42 days after delivery
Neonatal asphyxia ratethrough study completion, an average of 1 yearNeonatal asphyxia was diagnozed after the baby was deliverd
neonatal NICU admission ratethrough study completion, an average of 1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026