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Clinical Application of Intrapartum Ultrasound

Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06442735
Acronym
IPUS
Enrollment
455
Registered
2024-06-04
Start date
2022-01-01
Completion date
2023-12-31
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Labor, Complication of Delivery

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.

Interventions

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

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

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Those who reject ultrasound

Design outcomes

Primary

MeasureTime frameDescription
Duration of the first stage of laborDay 1Medical record about the length of first stage of labor
Duration of the second stage of laborDay 1Medical record about the length of second stage of labor
Number of Participants with feverDay 3physiological parameter about the body temperature when the patient has fever
Number of Participants with the soft birth canal laceration I, II,III, IVDay 1clinical 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)
Number of Participants with postpartum hemorrhageDay 1total postpartum blood loss in 24 hours measured by weighing method

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026