Umbilical Cord; Complications, Affecting FetusAssiutUNCT03504969
Perinatal Outcomes in Umbilical Cord Entanglement
An observational study of Umbilical Cord; Complications, Affecting Fetus, run by Assiut University.
Trial summary
Umbilical Cord Entanglement and Perinatal Outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord; Complications, Affecting Fetus
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jan 2020
- 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: women in active vaginal delivery
Who may be able to join
- all vaginal deliveries with or without Umbilical Cord Entanglement
Who cannot join
- multible pregnancy
About this study
Official title: Assiut University,Faculty of Medicine
Umbilical Cord Entanglement and Perinatal Outcomes.
Read the detailed description
Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery
- Keywords
- umbilical cord
What is being measured
The primary outcome is the main question the study is designed to answer.
perinatal outcomes
number of neonates with bad Apgar score
Measured: one year
Secondary outcomes (1)
delivery outcome
number of vaginal deliveries switch to S.C
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord; Complications, Affecting FetusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504969
- Sponsor's protocol ID
- Assiut71515
- Acronym
- AssiutU
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assiut University,Faculty of Medicine
- ClinicalTrials.gov ID
- NCT03504969
- Acronym / sponsor ID
- AssiutU / Assiut71515
- Keywords
- umbilical cord
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 20 Apr 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.
Umbilical Cord Entanglement and Perinatal Outcomes.
Detailed description
Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women in active vaginal delivery
Key inclusion criteria (1 listed)
- all vaginal deliveries with or without Umbilical Cord Entanglement
Key exclusion criteria (1 listed)
- multible pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
perinatal outcomes
Time frame: one year
number of neonates with bad Apgar score
1 secondary outcome
delivery outcome
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Cord; Complications, Affecting Fetus, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
perinatal outcomes (time frame: one year). 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 20 Apr 2018.