LabourNCT03515616
Evaluation of Labour Progress by PC Angle
An observational study of Labour, run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
Ultrasound during first stage of labour has a very important role in prediction of mode of delivery 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
- Labour
- What is being tested?
- TP us in labour
- How many people
- 300 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 May 2018to 14 Jun 2019
- 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: - primigravida who is pregnant full term with no medical disorders
Who may be able to join
- primigravida
- pregnant full term
- no medical disorders
Who cannot join
- multigravida
- any medical disorders
- preterm labour
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Kasralainy Hospital
Cairo
mohamed nabil, M.D, 01117385547
mohamed nabil, M.D, 01117385547, dr_monabil@hotmail.com
- Not yet recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Evaluation of Role of TP US in Progress of Labour by PC Angle & OS Angle
- Ultrasound during first stage of labour has a very important role in prediction of mode of delivery
Read the detailed description
-Operative delivery and cs delivery are increasing nowadays so US during labour is vital to predict these interventions
- Conditions
- Labour
- Being tested
- TP us in labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP us in labourDiagnostic test
TP US will be made to pregnant lady in first stage of labour with OS and PC angel measurements
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 NVD without instrumental intervention
the number of pregnant ladies in first stage of labour who will deliver by NVD and who will have normal progress or prolonged progress of labour
Measured: within 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start7 May 2018
- Primary completion10 May 2019 (estimated)
- Study completion14 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LabourStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mahmoud Alalfy, National Research Centre, Egypt
- Investigators
- Mahmoud Alalfy, M.s.c, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515616
- Sponsor's protocol ID
- labour assesment by US
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data which will be obtained from this study will be published
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
- Evaluation of Role of TP US in Progress of Labour by PC Angle & OS Angle
- ClinicalTrials.gov ID
- NCT03515616
- Acronym / sponsor ID
- labour assesment by US
- Conditions
- Labour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 7 May 2018 (actual)
- Primary completion
- 10 May 2019 (estimated)
- Study completion
- 14 Jun 2019 (estimated)
- First posted
- 3 May 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.
- Ultrasound during first stage of labour has a very important role in prediction of mode of delivery
Detailed description
-Operative delivery and cs delivery are increasing nowadays so US during labour is vital to predict these interventions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - primigravida who is pregnant full term with no medical disorders
Key inclusion criteria (3 listed)
- primigravida
- pregnant full term
- no medical disorders
Key exclusion criteria (3 listed)
- multigravida
- any medical disorders
- 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 |
|---|---|---|
| TP us in labourTP US will be made to pregnant lady in first stage of labour with OS and PC angel measurements | Diagnostic test | – |
Primary outcome
the number of participants who will deliver by NVD without instrumental intervention
Time frame: within 36 hours
the number of pregnant ladies in first stage of labour who will deliver by NVD and who will have normal progress or prolonged progress of labour
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: No. data which will be obtained from this study will be published
Related trials for Labour
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
Recruiting
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour Analgesia
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
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, M.s.c principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labour, run by Aljazeera Hospital at 2 sites 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 3 inclusion and 3 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 2 sites 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, M.s.c (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 NVD without instrumental intervention (time frame: within 36 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.