Application of Electronic Endoscope in Fetal Distress

NCT06608654 | Not Yet Recruiting

• 1 other identifier: EEFD-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Distress; Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

• fetal distress rate

  fetal distress rate during first stage of labor

  through study completion, an average of 1 year

Secondary Outcomes (4)

• vaginal delivery rate

  through study completion, an average of 1 year

• Incidence of maternal infection

  through study completion, an average of 1 year

• Neonatal asphyxia rate

  through study completion, an average of 1 year

• neonatal NICU admission rate

  through study completion, an average of 1 year

Study Arms (1)

fetal distress

EXPERIMENTAL

Device: endoscope application

Interventions

endoscope application DEVICE

Intrauterine bronchoscopy application for fetal distress during labor

fetal distress

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Taixing People's Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Fetal Distress; Fetal Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion: August 25, 2025
• Study Completion (Estimated): August 25, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)