Clinical Application of Intrapartum Ultrasound

Not Applicable

Completed

• Conditions: Complication of Delivery; Abnormal Labor
• Interventions: Other: vaginal examination; Other: intrapartum ultrasound

• Registration Number: NCT06442735
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-18
• Study First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 455

Inclusion Criteria

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

Exclusion Criteria

• Those who reject ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal examination	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.
Intrapartum ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Duration of the first stage of labor	Day 1	Medical record about the length of first stage of labor
Number of Participants with fever	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	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	Day 1	Medical record about the length of second stage of labor
Number of Participants with postpartum hemorrhage	Day 1	total postpartum blood loss in 24 hours measured by weighing method

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China