Preterm LaborNCT03251794
Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
An observational study of Preterm Labor, run by Assiut University at 1 site in Egypt.
Trial summary
Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003. Prematurity causes 70% of fetal/neonatal deaths. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- three dimensional ultrasound and color Doppler
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 18 Apr 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: women with threatened preterm labor
Who may be able to join
- singleton fetus less than 37 weeks of gestation
- women diagnosed to having Threatened preterm labor.
- presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
- cervical effacement <80 %
- cervical dilatation <1 cm
Who cannot join
- suspected fetal growth restriction,
- maternal medical complications,
- presence of fetal heart rate abnormalities at enrollment.
- Preterm Premature rupture of membranes
- Placenta previa
- Lower urinary tract infection or genital infection
- Fetal congenital anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.
Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%
- Conditions
- Preterm Labor
- Being tested
- three dimensional ultrasound, color Doppler
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three dimensional ultrasoundDiagnostic test
evaluation of the suprarenal glands
color DopplerDiagnostic test
Doppler evaluation of the suprarenal artery
| Study group | Role | What they receive |
|---|---|---|
| threatened preterm labor | women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix Receives: Diagnostic Test: three dimensional ultrasound; Diagnostic Test: color Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of adrenal gland
measurement by three dimensional ultrasound
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Mar 2017
- Primary completion15 Mar 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251794
- Sponsor's protocol ID
- FAGE
- Status last verified
- Jun 2018
- First submitted
- 13 Aug 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT03251794
- Acronym / sponsor ID
- FAGE
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 16 Aug 2017 (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.
Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.
Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| threatened preterm labor | – | Diagnostic Test: three dimensional ultrasound, Diagnostic Test: color Dopplerwomen presented to the reception unit from 28-37 weeks by regular contractions and opened cervix |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women with threatened preterm labor
Key inclusion criteria (5 listed)
- singleton fetus less than 37 weeks of gestation
- women diagnosed to having Threatened preterm labor.
Key exclusion criteria (7 listed)
- suspected fetal growth restriction,
- maternal medical complications,
- presence of fetal heart rate abnormalities at enrollment.
- Preterm Premature rupture of membranes
- Placenta previa
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 |
|---|---|---|
| three dimensional ultrasoundevaluation of the suprarenal glands | Diagnostic test | threatened preterm labor |
| color DopplerDoppler evaluation of the suprarenal artery | Diagnostic test | threatened preterm labor |
Primary outcome
the volume of adrenal gland
Time frame: 5 minutes
measurement by three dimensional ultrasound
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 27 Jun 2018.
- 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 Preterm Labor, run by Assiut 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 7 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 27 Jun 2018. 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?
the volume of adrenal gland (time frame: 5 minutes). 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 27 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.