Premature BirthNCT02120378
Fetal Viability Estimation in Egypt
An observational study of Premature Birth and Miscarriage, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Birth, Miscarriage
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Sep 2015
- How long will I take part?
- 3 Months
- 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
- No healthy volunteers
- Adult
Study population: females presenting to the causality department in kasr el Aini hospital presenting with signs of preterm labor ( uterine contractions before completing 38 weeks of gestation)
Who may be able to join
- pregnant females age from 18- 40 years old
- preterm delivery before completing 38 weeks of gestation
- singleton or multiple gestation
- fetuses with congenital anomalies
Who cannot join
- refusal to get enrolled in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Aini
Cairo, Cairo Governorate, 12211
dina M dakhly, MD, +201003498919, dinadakhly@gmail.com
dina M dakhly, MD
About this study
Official title: Correlation Between Fetal Gestational Age, Viability and Survival Rates in Egypt
Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.
- Conditions
- Premature Birth, Miscarriage
- Keywords
- miscarriage, fetal viability, prematurity
- Medical subject headings
- Premature Birth, Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of age of fetal viability according the survival rate percentage
Measured: 1 year
Secondary outcomes (2)
most common causes for premature delivery in Egypt
Measured: 6 months
the mode of delivery of preterm cases in Egypt
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Cairo University
- Investigators
- dina m dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120378
- Sponsor's protocol ID
- WH142014
- Status last verified
- Mar 2015
- First submitted
- 17 Apr 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Fetal Gestational Age, Viability and Survival Rates in Egypt
- ClinicalTrials.gov ID
- NCT02120378
- Acronym / sponsor ID
- WH142014
- Conditions
- Premature Birth, Miscarriage
- Keywords
- miscarriage, fetal viability, prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 22 Apr 2014 (estimated)
- 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.
Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- females presenting to the causality department in kasr el Aini hospital presenting with signs of preterm labor ( uterine contractions before completing 38 weeks of gestation)
Key inclusion criteria (4 listed)
- pregnant females age from 18- 40 years old
- preterm delivery before completing 38 weeks of gestation
- singleton or multiple gestation
- fetuses with congenital anomalies
Key exclusion criteria (1 listed)
- refusal to get enrolled in the study
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
determination of age of fetal viability according the survival rate percentage
Time frame: 1 year
2 secondary outcomes
most common causes for premature delivery in Egypt
Time frame: 6 months
the mode of delivery of preterm cases in Egypt
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
Related trials for Premature Birth
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
dina m dakhly, MD principal investigator
Cairo University
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 Premature Birth and Miscarriage, run by Woman's Health University Hospital, Egypt 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 4 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 31 Mar 2015. 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 dina m dakhly, MD (201003498919, dinadakhly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of age of fetal viability according the survival rate percentage (time frame: 1 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 31 Mar 2015.