Prolonged LaborNCT05206409
Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.
An observational study of Prolonged Labor, run by Ain Shams University at 1 site in Egypt.
Trial summary
In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Ultrasound
- How many people
- 382 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2022to 30 Aug 2023
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nulliparous women with delayed first stage of Labor
Who may be able to join
- nulliparous women
- Singleton pregnancy
- prolonged first stage of Labor
- average fetal weight
- gestational age at or beyond 37 weeks
Who cannot join
- IUFD
- malpresentation
Trial locations and contacts
1 site in 1 country.
About this study
In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.
- Conditions
- Prolonged Labor
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Fetal head position determination using ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Correlation between fetal head position and mode of delivery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start25 Jan 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206409
- Sponsor's protocol ID
- MS 747/2021
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.
- ClinicalTrials.gov ID
- NCT05206409
- Acronym / sponsor ID
- MS 747/2021
- Conditions
- Prolonged Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 25 Jan 2022 (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.
In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nulliparous women with delayed first stage of Labor
Key inclusion criteria (5 listed)
- nulliparous women
- Singleton pregnancy
- prolonged first stage of Labor
- average fetal weight
- gestational age at or beyond 37 weeks
Key exclusion criteria (2 listed)
- IUFD
- malpresentation
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 |
|---|---|---|
| UltrasoundFetal head position determination using ultrasound | Diagnostic test | – |
Primary outcome
Mode of delivery
Time frame: 6 months
Correlation between fetal head position and mode of delivery
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 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Prolonged Labor, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 2 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 17 Oct 2023. 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 Egypt. 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?
Mode of delivery (time frame: 6 months). 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 17 Oct 2023.