Labor LongNCT03471780
Evaluation of Transperineal US in Labour
An observational study of Labor Long, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Assessment of progress of labour is an important step in decision making of obstetricians Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Long
- What is being tested?
- ultrasound
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2018to 10 Apr 2019
- How long will I take part?
- 1 Day
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * pregnant women in labour * Full term
Who may be able to join
- pregnant women in labour
- Full term
Who cannot join
- pregnant ladies not in labour
- Preterm labour
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: The Importance of Transperineal US in Labour
Assessment of progress of labour is an important step in decision making of obstetricians
Read the detailed description
delayed progress of labour resemble an annoying problem to obstetrician so noninvasive diagnostic methods can play an important role in implementing a guidelines to follow patients in labour as transperineal US .
- Conditions
- Labor Long
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Transperineal us are made to pregnant ladies in labour
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants who will deliver by normal delivery
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start8 Jan 2018
- Primary completion10 Apr 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor LongStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471780
- Sponsor's protocol ID
- labour US
- Status last verified
- Jan 2019
- First submitted
- 14 Mar 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan is decided now
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Transperineal US in Labour
- ClinicalTrials.gov ID
- NCT03471780
- Acronym / sponsor ID
- labour US
- Conditions
- Labor Long
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 10 Apr 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 21 Mar 2018 (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.
Assessment of progress of labour is an important step in decision making of obstetricians
Detailed description
delayed progress of labour resemble an annoying problem to obstetrician so noninvasive diagnostic methods can play an important role in implementing a guidelines to follow patients in labour as transperineal US .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * pregnant women in labour * Full term
Key inclusion criteria (2 listed)
- pregnant women in labour
- Full term
Key exclusion criteria (2 listed)
- pregnant ladies not in labour
- Preterm labour
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 |
|---|---|---|
| ultrasoundTransperineal us are made to pregnant ladies in labour | Diagnostic test | – |
Primary outcome
the number of participants who will deliver by normal delivery
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: Undecided. no plan is decided now
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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.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
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 Labor Long, run by Aljazeera Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of participants who will deliver by normal delivery (time frame: within 24 hours). 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 9 Jan 2019.