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NCT Number: NCT06608654

Application of Electronic Endoscope in Fetal Distress

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

endoscope application

Device

Intrauterine bronchoscopy application for fetal distress during labor

Primary outcomes

  1. fetal distress rate

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

    fetal distress rate during first stage of labor

Secondary outcomes

  1. vaginal delivery rate

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

    baby was deliverd vaginally

  2. Incidence of maternal infection

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

    materna infection was diagnozed up to 42 days after delivery

  3. Neonatal asphyxia rate

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

    Neonatal asphyxia was diagnozed after the baby was deliverd

  4. neonatal NICU admission rate

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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Taixing People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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