Abnormal LaborIPUSNCT06442735
Clinical Application of Intrapartum Ultrasound
A study testing intrapartum ultrasound and vaginal examination in people with Abnormal Labor and Complication of Delivery, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abnormal Labor, Complication of Delivery
- What is being tested?
- intrapartum ultrasound and vaginal examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All pregnant women in the delivery room for vaginal trial labor
Who cannot join
- Those who reject ultrasound
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
About this study
Official title: 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.
Read the 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.
- Conditions
- Abnormal Labor, Complication of Delivery
- Being tested
- intrapartum ultrasound, vaginal examination
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrapartum ultrasoundOther
In IPUS group, the patient's labor was observed by intrapartum ultrasound.
vaginal examinationOther
In VE group, the patient's labor was observed by vaginal examination.
| Study group | Role | What they receive |
|---|---|---|
| Intrapartum ultrasound | Experimental | 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. Receives: Other: intrapartum ultrasound |
| Vaginal examination | Active comparator | 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. Receives: Other: vaginal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the first stage of labor
Medical record about the length of first stage of labor
Measured: Day 1
Duration of the second stage of labor
Medical record about the length of second stage of labor
Measured: Day 1
Number of Participants with fever
physiological parameter about the body temperature when the patient has fever
Measured: 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）
Measured: Day 1
Number of Participants with postpartum hemorrhage
total postpartum blood loss in 24 hours measured by weighing method
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Li, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442735
- Sponsor's protocol ID
- A2023-264-01
- Acronym
- IPUS
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated or analyzed during this study are available from the Central Contact Person on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor
- ClinicalTrials.gov ID
- NCT06442735
- Acronym / sponsor ID
- IPUS / A2023-264-01
- Conditions
- Abnormal Labor, Complication of Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrapartum ultrasound | Experimental | Other: intrapartum ultrasoundIPUS 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. |
| Vaginal examination | Active comparator | Other: vaginal examinationVE 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All pregnant women in the delivery room for vaginal trial labor
Key exclusion criteria (1 listed)
- Those who reject ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrapartum ultrasoundIn IPUS group, the patient's labor was observed by intrapartum ultrasound. | Other | Intrapartum ultrasound |
| vaginal examinationIn VE group, the patient's labor was observed by vaginal examination. | Other | Vaginal examination |
Primary outcome
Duration of the first stage of labor
Time frame: Day 1
Medical record about the length of first stage of labor
Duration of the second stage of labor
Time frame: Day 1
Medical record about the length of second stage of labor
Number of Participants with fever
Time frame: 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
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）
Number of Participants with postpartum hemorrhage
Time frame: Day 1
total postpartum blood loss in 24 hours measured by weighing method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No. All data generated or analyzed during this study are available from the Central Contact Person on reasonable request.
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Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrapartum ultrasound and vaginal examination in people with Abnormal Labor and Complication of Delivery, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the first stage of labor (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.