Clinical Application of Intrapartum Ultrasound

NCT ID: NCT06442735

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Abnormal Labor Complication of Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intrapartum ultrasound

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.

Group Type EXPERIMENTAL

intrapartum ultrasound

Intervention Type OTHER

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

Vaginal examination

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.

Group Type ACTIVE_COMPARATOR

vaginal examination

Intervention Type OTHER

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

Interventions

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intrapartum ultrasound

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

Intervention Type OTHER

vaginal examination

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Those who reject ultrasound
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Ping Li

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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A2023-264-01

Identifier Type: -

Identifier Source: org_study_id

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