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Completed

NCT Number: NCT06442735

Clinical Application of Intrapartum Ultrasound

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.

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Key information

Conditions

Abnormal Labor Complication of Delivery Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Those who reject ultrasound

Treatment and study plan

intrapartum ultrasound

Other

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

vaginal examination

Other

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

Primary outcomes

  1. Duration of the first stage of labor

    Time frame: Day 1

    Medical record about the length of first stage of labor

  2. Duration of the second stage of labor

    Time frame: Day 1

    Medical record about the length of second stage of labor

  3. Number of Participants with fever

    Time frame: Day 3

    physiological parameter about the body temperature when the patient has fever

  4. Number of Participants with the soft birth canal laceration I, II,III, IV

    Time frame: 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）

  5. Number of Participants with postpartum hemorrhage

    Time frame: Day 1

    total postpartum blood loss in 24 hours measured by weighing method

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor

Acronym: IPUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2024
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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