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Clinical Trials/NCT06442735
NCT06442735
Completed
Not Applicable

Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor

Third Affiliated Hospital, Sun Yat-Sen University1 site in 1 country455 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abnormal Labor
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Enrollment
455
Locations
1
Primary Endpoint
Duration of the first stage of labor
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

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. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Principal Investigator
Principal Investigator

Ping Li

Clinical Professor

Third Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Those who reject ultrasound

Outcomes

Primary Outcomes

Duration of the first stage of labor

Time Frame: Day 1

Medical record about the length of first stage of labor

Number of Participants with fever

Time Frame: Day 3

physiological parameter about the body temperature when the patient has fever

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

Time Frame: Day 1

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)

Duration of the second stage of labor

Time Frame: Day 1

Medical record about the length of second stage of labor

Number of Participants with postpartum hemorrhage

Time Frame: Day 1

total postpartum blood loss in 24 hours measured by weighing method

Study Sites (1)

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