Application of Electronic Endoscope in Fetal Distress

NCT ID: NCT06608654

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-08-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

fetal distress

Group Type: EXPERIMENTAL

endoscope application

Intervention Type: DEVICE

Intrauterine bronchoscopy application for fetal distress during labor

Interventions

endoscope application

Intrauterine bronchoscopy application for fetal distress during labor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taixing People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

EEFD-01

Identifier Type: -

Identifier Source: org_study_id