Clinical Application of Intrapartum Ultrasound

Abnormal Labor Clinical Trial

— IPUS  

Official title:

Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442735
• Other study ID #: A2023-264-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Those who reject ultrasound

Related Conditions & MeSH terms

• Abnormal Labor
• Complication of Delivery
• Dystocia

Intervention

Other:
• intrapartum ultrasound
In IPUS group, the patient's labor was observed by intrapartum ultrasound.
• vaginal examination
In VE group, the patient's labor was observed by vaginal examination.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the first stage of labor	Medical record about the length of first stage of labor	Day 1
Primary	Duration of the second stage of labor	Medical record about the length of second stage of labor	Day 1
Primary	Number of Participants with fever	physiological parameter about the body temperature when the patient has fever	Day 3
Primary	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
Primary	Number of Participants with postpartum hemorrhage	total postpartum blood loss in 24 hours measured by weighing method	Day 1