Clinical Application of Intrapartum Ultrasound (IPUS)

Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor

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.

Study Overview

• Status: Completed
• Conditions: Complication of Delivery; Abnormal Labor
• Intervention / Treatment: Other: intrapartum ultrasound; Other: vaginal examination

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.

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Those who reject ultrasound

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: intrapartum ultrasound; In IPUS group, the patient's labor was observed by intrapartum ultrasound.
Active Comparator: 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.	Other: vaginal examination; In VE group, the patient's labor was observed by vaginal examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 18, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dystocia
• Other Study ID Numbers: A2023-264-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data generated or analyzed during this study are available from the Central Contact Person on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No