Application of Electronic Endoscope in Fetal Distress

NCT06608654 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Not applicable

Started

2024-10-01

Last updated

2024-09-23

Condition(s) studied

Fetal DistressFetal Hypoxia

Investigational drug(s) / intervention(s)

endoscope application

endoscope application: Intrauterine bronchoscopy application for fetal distress during labor

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.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

45 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

fetal distress rate — through study completion, an average of 1 year
fetal distress rate during first stage of labor

Trial sites (1)

Facility	City	Region	Status
First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608654 on ClinicalTrials.gov ↗ ← All trials in China