Preterm BirthNCT02339623
Fetal Adrenal Gland Volume Estimation in Prediction of Preterm Birth
An observational study of Preterm Birth, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , we would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Ultrasound imaging
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Feb 2015
- 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: Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) : * Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes ) * Cervical dilataion >1cm, \&/or * Cervical effacement ≥ 80%
Who may be able to join
- 1. Age : 18 - 40 years 2. Gestational age : 26 - 35 weeks , which is going to be calculated according to the date of last menstrual period \& confirmed by first trimester ultrasonography .
- 3 - Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) :
- Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes )
- Cervical dilataion >1cm, \&/or
- Cervical effacement ≥ 80% 4. Women having one or more of the following:
- Multifetal pregnancy .
- Previous preterm labor or premature birth, particularly in the most recent pregnancy or in more than one previous pregnancy .
Who cannot join
- 1 - Suspected fetal growth restriction . 2- Preterm premature rupture of the membranes : confirmed by visualization of amniotic fluid vaginal pooling at the time of sterile speculum examination .
- 3- Patients with antepartum haemorrhage ( due to placental abruption \&/or placenta previa ) .
- 4 - Presence of fetal anomalies incompatible with life. 5 - Patients who are not sure of dates .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo
Wessam M Abouelghar, MD, 002-01227460679, dr.awessam@gmail.com
Rania A Rizk, M.B, B.Ch
About this study
Official title: Three - Dimensional Ultrasound Estimation of Fetal Adrenal Gland Enlargement Compared to Assessment of Cervical Changes Alone & Prediction of Impending Preterm Birth
If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , we would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB which can be positively reflected on the risk of neonatal morbidity and mortality in those patients.
Read the detailed description
Preterm birth ( PTB) is one of the leading causes of neonatal morbidity and mortality (Goldenberg et al., 2008) Early PTB (≤ 34 weeks' gestation) carries a 7-fold increased risk of Neonatal death . Following PTB, survivors can experience significant long term cognitive, behavioral, emotional, sensory, and motor deficits. Hence, there is growing interest in the identification of women who are at Risk for spontaneous PTB. Many biophysical and biochemical markers have been discovered to identify those women who are at risk for spontaneous PTB.
(Honest et al., 2009)
Unfortunately, none of the various maternal and fetal biomarkers such as:
cytokines, CRH, C-reactive protein, fetal fibronectin ,…. etc. are sufficiently sensitive or specific to be used alone or in combination to help decrease the rate of preterm births. (Ozhan et al., 2007) Obviously, there's a need for an accurate method with high sensitivity and specificity for prediction of preterm labor. So that an appropriate management or referral to a higher center can be done to women likely to have PTB. Whereas unnecessary tocolytic therapy can be avoided in women who are unlikely to have PTB. (Rengaraj et al., 2009) Convincing data have shown that 2-dimensional (2D) ultrasound measurement of cervical length (CL) can identify women at risk for PTB.
Accordingly, CL is now widely used in clinical practice for risk estimation. ( Crane et al., 1997) However, as understanding of the mechanisms of preterm labor (PTL) have evolved, obstetricians have learned that, in some women, cervical shortening is a phenomenon that carries no increased risk for prematurity. Therefore, the search for early and accurate markers that distinguish between physiologic processes and abnormal activation of the labor cascade has been ongoing.
Literature has suggested that activation of the fetal hypothalamic-pituitary-adrenal axis play a crucial rule in commencement of labor. (Norwitz et al, 1999) A previous study demonstrated that three -dimensional ultrasound measurement of fetal adrenal gland volume (AGV) may identify women at risk for impending PTB. (Turan et al, 2007) In a more recent study receiver operator characteristics (ROC) curve analysis revealed that three -dimensional ultrasound measurement of (AGV) was superior to two-dimensional ultrasound measurement of (AGV) for anticipation of PTB within 7 days of the scan. (Turan et al, 2012) The aim of this study is to investigate the utility of 3D fetal adrenal gland volume measurement in the early prediction of PTB and to determine whether these measurements could be combined with 2D ultrasound cervical assessment to improve the early prediction of PTB.
- Conditions
- Preterm Birth
- Being tested
- Ultrasound imaging
- Keywords
- Threatened preterm birth - fetal adrenal gland volume
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingDevice
- - Fetal adrenal gland volume calculation using 3D ultrasound
- - Assessment of the fetal central adrenal zone enlargement by 3D ultrasound
- - CL measurement using 2D ultrasound
| Study group | Role | What they receive |
|---|---|---|
| threatened preterm labour | Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) :
* Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes )
* Cervical dilataion >1cm, \&/or
* Cervical effacement ≥ 80% Receives: Device: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume
If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , we would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB which can be positively reflected on the risk of neonatal morbidity and mortality in those patients.
Measured: within 7 days of ultrasound scan
Secondary outcomes (1)
accurecy of measuring cervical length in prediction of impending preterm birth
Measured: 7 days of ultrasound scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ahmed Mohammed Rizk, Ain Shams Maternity Hospital
- Investigators
- Wessam Ma Abouelghar, MD, Study chair, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339623
- Sponsor's protocol ID
- ACTG 021
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turan OM, Turan S, Funai EF, Buhimschi IA, Campbell CH, Bahtiyar OM, Harman CR, Copel JA, Buhimschi CS, Baschat AA. Ultrasound measurement of fetal adrenal gland enlargement: an accurate predictor of preterm birth. Am J Obstet Gynecol. 2011 Apr;204(4):311.e1-10. doi: 10.1016/j.ajog.2010.11.034. Epub 2011 Feb 3.
PubMed 21292230
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three - Dimensional Ultrasound Estimation of Fetal Adrenal Gland Enlargement Compared to Assessment of Cervical Changes Alone & Prediction of Impending Preterm Birth
- ClinicalTrials.gov ID
- NCT02339623
- Acronym / sponsor ID
- ACTG 021
- Conditions
- Preterm Birth
- Keywords
- Threatened preterm birth - fetal adrenal gland volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 15 Jan 2015 (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.
If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , we would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB which can be positively reflected on the risk of neonatal morbidity and mortality in those patients.
Detailed description
Preterm birth ( PTB) is one of the leading causes of neonatal morbidity and mortality (Goldenberg et al., 2008) Early PTB (≤ 34 weeks' gestation) carries a 7-fold increased risk of Neonatal death . Following PTB, survivors can experience significant long term cognitive, behavioral, emotional, sensory, and motor deficits. Hence, there is growing interest in the identification of women who are at Risk for spontaneous PTB. Many biophysical and biochemical markers have been discovered to identify those women who are at risk for spontaneous PTB.
(Honest et al., 2009)
Unfortunately, none of the various maternal and fetal biomarkers such as:
cytokines, CRH, C-reactive protein, fetal fibronectin ,…. etc. are sufficiently sensitive or specific to be used alone or in combination to help decrease the rate of preterm births. (Ozhan et al., 2007) Obviously, there's a need for an accurate method with high sensitivity and specificity for prediction of preterm labor. So that an appropriate management or referral to a higher center can be done to women likely to have PTB. Whereas unnecessary tocolytic therapy can be avoided in women who are unlikely to have PTB. (Rengaraj et al., 2009) Convincing data have shown that 2-dimensional (2D) ultrasound measurement of cervical length (CL) can identify women at risk for PTB.
Accordingly, CL is now widely used in clinical practice for risk estimation. ( Crane et al., 1997) However, as understanding of the mechanisms of preterm labor (PTL) have evolved, obstetricians have learned that, in some women, cervical shortening is a phenomenon that carries no increased risk for prematurity. Therefore, the search for early and accurate markers that distinguish between physiologic processes and abnormal activation of the labor cascade has been ongoing.
Literature has suggested that activation of the fetal hypothalamic-pituitary-adrenal axis play a crucial rule in commencement of labor. (Norwitz et al, 1999) A previous study demonstrated that three -dimensional ultrasound measurement of fetal adrenal gland volume (AGV) may identify women at risk for impending PTB. (Turan et al, 2007) In a more recent study receiver operator characteristics (ROC) curve analysis revealed that three -dimensional ultrasound measurement of (AGV) was superior to two-dimensional ultrasound measurement of (AGV) for anticipation of PTB within 7 days of the scan. (Turan et al, 2012) The aim of this study is to investigate the utility of 3D fetal adrenal gland volume measurement in the early prediction of PTB and to determine whether these measurements could be combined with 2D ultrasound cervical assessment to improve the early prediction of PTB.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| threatened preterm labour | – | Device: Ultrasound imagingWomen who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) : * Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes ) * Cervical dilataion >1cm, \&/or * Cervical effacement ≥ 80% |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) : * Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes ) * Cervical dilataion >1cm, \&/or * Cervical effacement ≥ 80%
Key inclusion criteria (7 listed)
- 1. Age : 18 - 40 years 2. Gestational age : 26 - 35 weeks , which is going to be calculated according to the date of last menstrual period \& confirmed by first trimester ultrasonography .
- 3 - Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) :
- Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes )
- Cervical dilataion >1cm, \&/or
- Cervical effacement ≥ 80% 4. Women having one or more of the following:
Key exclusion criteria (3 listed)
- 1 - Suspected fetal growth restriction . 2- Preterm premature rupture of the membranes : confirmed by visualization of amniotic fluid vaginal pooling at the time of sterile speculum examination .
- 3- Patients with antepartum haemorrhage ( due to placental abruption \&/or placenta previa ) .
- 4 - Presence of fetal anomalies incompatible with life. 5 - Patients who are not sure of dates .
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 |
|---|---|---|
| Ultrasound imaging1. - Fetal adrenal gland volume calculation using 3D ultrasound 2. - Assessment of the fetal central adrenal zone enlargement by 3D ultrasound 3. - CL measurement using 2D ultrasound | Device | threatened preterm labour |
Primary outcome
Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume
Time frame: within 7 days of ultrasound scan
If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , we would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB which can be positively reflected on the risk of neonatal morbidity and mortality in those patients.
1 secondary outcome
accurecy of measuring cervical length in prediction of impending preterm birth
Time frame: 7 days of ultrasound scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Background: PubMed 21292230Turan OM, Turan S, Funai EF, Buhimschi IA, Campbell CH, Bahtiyar OM, Harman CR, Copel JA, Buhimschi CS, Baschat AA. Ultrasound measurement of fetal adrenal gland enlargement: an accurate predictor of preterm birth. Am J Obstet Gynecol. 2011 Apr;204(4):311.e1-10. doi: 10.1016/j.ajog.2010.11.034. Epub 2011 Feb 3.
- Ultrasound measurement of fetal adrenal gland enlargement: an accurate predictor of preterm birth.Link provided by the sponsor.
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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.
Wessam Ma Abouelghar, MD study chair
Ain Shams Maternity Hospital
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 Birth, run by Ain Shams Maternity Hospital 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 7 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 15 Jan 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 Rania A Rizk, M.B, B.Ch (002-01222799057, dr_rania.rizk@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume (time frame: within 7 days of ultrasound scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339623, which also lists 1 linked publication.
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 15 Jan 2015.