Clinical Application of Intrapartum Ultrasound

NCT06442735 | Completed DMC

• 1 other identifier: A2023-264-01
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.

Conditions

Abnormal Labor; Complication of Delivery

Outcome Measures

Primary Outcomes (5)

• Duration of the first stage of labor

  Medical record about the length of first stage of labor

  Day 1

• Duration of the second stage of labor

  Medical record about the length of second stage of labor

  Day 1

• Number of Participants with fever

  physiological parameter about the body temperature when the patient has fever

  Day 3

• Number of Participants with the soft birth canal laceration I, II,III, IV

  clinical assessment about the soft birth canal laceration after labor, including I(Perineal skin and vaginal entrance mucosa laceration, little bleeding）, II（The lacerated injury has reached the fascia and muscle layer of the perineum, involved the mucous membrane of the posterior wall of the vagina, extended to the groove on both sides of the posterior wall of the vagina and tore upward, the anatomical structure is not easy to identify, and there is more bleeding）,III（The lacerated wound extends deep into the perineum, the external anal sphincter is broken, and the rectal mucosa is intact）, IV（The anus, rectum and vagina are completely penetrated, the rectointestinal cavity is exposed, the histological tissue is seriously damaged）

  Day 1

• Number of Participants with postpartum hemorrhage

  total postpartum blood loss in 24 hours measured by weighing method

  Day 1

Study Arms (2)

Intrapartum ultrasound

EXPERIMENTAL

IPUS group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by intrapartum ultrasound.

Other: intrapartum ultrasound

Vaginal examination

ACTIVE COMPARATOR

VE group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by vaginal examination.

Other: vaginal examination

Interventions

intrapartum ultrasound OTHER

In IPUS group, the patient's labor was observed by intrapartum ultrasound.

Intrapartum ultrasound

vaginal examination OTHER

In VE group, the patient's labor was observed by vaginal examination.

Vaginal examination

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All pregnant women in the delivery room for vaginal trial labor

You may not qualify if:

• Those who reject ultrasound

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 4, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)