Fetal DistressNCT03159234
Prediction of Fetal Lung Maturity
A study testing fetal lung volume, pulmonary artery resistance index and Fetal adrenal gland volume: in people with Fetal Distress, run by Assiut University at 1 site in Egypt.
Trial summary
Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes. Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fetal Distress
- What is being tested?
- fetal lung volume, pulmonary artery resistance index and Fetal adrenal gland volume:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to May 2017
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All pregnant diabetic women
- 37 weeks gestational age .
Who cannot join
- Women before 37 and after 39 weeks gestational age
- Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
- Multiple pregnancies.
- Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
- Women with premature rupture of membranes (prom)
- Pregnancies complicated by medical disorders other than diabetes mellitus .
- Failure to obtain an informed consent .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers
Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.
Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.
- Conditions
- Fetal Distress
- Being tested
- fetal lung volume, pulmonary artery resistance index, Fetal adrenal gland volume:
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal lung volumeRadiation
the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia
pulmonary artery resistance indexRadiation
Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery
Fetal adrenal gland volume:Radiation
the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic pregnant women | Other | Not described Receives: Radiation: fetal lung volume; Radiation: pulmonary artery resistance index; Radiation: Fetal adrenal gland volume: |
What is being measured
The primary outcome is the main question the study is designed to answer.
APGAR score
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 posted18 May 2017
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159234
- Sponsor's protocol ID
- 17100188
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 18 May 2017
- 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 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers
- ClinicalTrials.gov ID
- NCT03159234
- Acronym / sponsor ID
- 17100188
- Conditions
- Fetal Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 May 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.
Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.
Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic pregnant women | Other | Radiation: fetal lung volume, Radiation: pulmonary artery resistance index, Radiation: Fetal adrenal gland volume: |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All pregnant diabetic women
- 37 weeks gestational age .
Key exclusion criteria (7 listed)
- Women before 37 and after 39 weeks gestational age
- Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
- Multiple pregnancies.
- Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
- Women with premature rupture of membranes (prom)
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 |
|---|---|---|
| fetal lung volumethe best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia | Radiation | Diabetic pregnant women |
| pulmonary artery resistance indexWomen placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery | Radiation | Diabetic pregnant women |
| Fetal adrenal gland volume:the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla. | Radiation | Diabetic pregnant women |
Primary outcome
APGAR score
Time frame: 5 minutes
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 18 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Distress
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The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
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The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
Fetal Health Anxiety, Prenatal Distress
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Maternal Oxygen Supplementation for Intrauterine Resuscitation
Fetal Distress, Fetal Hypoxia
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?
A study testing fetal lung volume, pulmonary artery resistance index and Fetal adrenal gland volume: in people with Fetal Distress, 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 2 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 18 May 2017. 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?
APGAR score (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 18 May 2017.