Fetal Growth RetardationNCT04640467
Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio
An observational study of Fetal Growth Retardation and Stillbirth, run by Assiut University at 1 site in Egypt.
Trial summary
To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Growth Retardation, Stillbirth, Neonatal Respiratory Failure
- What is being tested?
- Biophsical profile and Cerebroplacental ratio
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Nov 2022
- 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
- Child, Adult, Older adult
Study population: Women with uncomplicated singleton pregnancy who are planning a vaginal delivery. Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) with cephalic presentation
Who may be able to join
- •Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
- Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
- Cephalic presentation
Who cannot join
- •Multiple pregnancy
- known SGA fetus.
- Medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia
- Known fetal anomaly or aneuploidy or stillbirth.
- Any contraindication of vaginal delivery eg. placenta previa.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Women's Health Hospital, Assiut University Hospital
Asyut, 71515
Mariam Sobhy, MBBCH, +201095811120, rrrrgds83@gmail.com
About this study
Official title: Prediction of Late Fetal Growth Restriction in Uncomplicated Pregnancies Using Cerebroplacental Ratio: a Prospective Cohort Study
To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies
Read the detailed description
Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as
- AC/EFW < 3rd centile Or at least two out of three of:
- AC/EFW < 10th centile
- AC/EFW crossing centiles >2 quartiles
- Cerebroplacental ratio (CPR) <5th centile or Umbilical artery Pusitility Index(UAPI )>95th centile FGR fetuses will not necessarily be SGA at delivery and vice versa. In fact, most SGA are likely to be 'constitutionally' small CPR is the ratio of the Middle cerebral artery Pulsatility Index (MCAPI) to (UAPI). The CPR gradually rises until around the 34th week and subsequently slowly declines until term. Its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord pH, admission to the intensive care unit and poor neurological outcomes The biophysical profile (BPP) abnormalities that characterize late FGR include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( CTG). It seems that BPP becomes abnormal only shortly before stillbirth .
- Being tested
- Biophsical profile, Cerebroplacental ratio
- Keywords
- Cerebroplacental ratio, Fetal growth restriction, Term pregnancy, Doppler ultrasound
- Medical subject headings
- Fetal Growth Retardation, Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biophsical profileDiagnostic test
Also called BPP
There are five components measured during the biophysical examination. A score of 2 points is given for each component that meets criteria. The test is continued until all criteria are met or 30 minutes have elapsed. The points are then added for a possible maximum score of 10. A total score of 10 out of 10 or 8 out of 10 with normal fluid is considered normal. A score of 6 is considered equivocal, and a score of 4 or less is abnormal.
Cerebroplacental ratioDiagnostic test
Also called CPR
CPR is the ratio of the Middle Cerebral Artery Pulsatility Index (MCA PI) to the Umbilical Artery Pulsatility Index (UA PI). The pulsatility indices will be measured from an automated trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The angle of insonation will be as close to zero degrees as possible. The UA PI will be recorded from a free-floating section of cord, and the MCA PI will be obtained from the proximal third of the vessel (10, 14).
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women with uncomplicated singleton pregnancy who are planning a vaginal delivery, gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) and cephalic presentation Receives: Diagnostic Test: Biophsical profile; Diagnostic Test: Cerebroplacental ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of adverse neonatal outcomes
Apgar score ≤7 at 5 min or resuscitation with intubation, chest compressions or medication, admission to NICU ≥ 48 hours or hypoxic ischemic encephalopathy or cerebral palsy or stillbirth or neonatal death within 28 days
Measured: Up to 48 hours After delivery
Secondary outcomes (4)
Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)
The diagnosis of IFC will be made by the treating obstetrician based on abnormal fetal heart rate patterns (classified according to National Institute for Health and Clinical excellence [NICE] guidelines ) (15) or presence of meconium stained liquor.
Measured: At time of delivery
Demographic characteristics of the cohort
Demographic characteristics of the cohort
Measured: Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
Estimated fetal weight
An ultrasonographic measurement using Hadlock formula (13)
Measured: At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
Birth weight
Birth weight in kilograms
Measured: Immediatly after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Sobhy Shawky, Assiut University
- Investigators
- Mariam Sobhy, MBBCH, Principal investigator, Assiut UniversityAhmed Aboelhasan, MD, Principal investigator, Assiut UniversityMoustafa Gadalla, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640467
- Sponsor's protocol ID
- CPR in late growth restriction
- Status last verified
- Jan 2021
- First submitted
- 19 Sep 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sherrell H, Clifton V, Kumar S. Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: randomised controlled trial protocol. BMJ Open. 2018 Aug 13;8(8):e022567. doi: 10.1136/bmjopen-2018-022567.
PubMed 30104317Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.
PubMed 32738107Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.
PubMed 26909664Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.
PubMed 25346493Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.
PubMed 17721916Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Oros D, Gratacos E. Fetal brain Doppler to predict cesarean delivery for nonreassuring fetal status in term small-for-gestational-age fetuses. Obstet Gynecol. 2011 Mar;117(3):618-626. doi: 10.1097/AOG.0b013e31820b0884.
PubMed 21343765Stampalija T, Thornton J, Marlow N, Napolitano R, Bhide A, Pickles T, Bilardo CM, Gordijn SJ, Gyselaers W, Valensise H, Hecher K, Sande RK, Lindgren P, Bergman E, Arabin B, Breeze AC, Wee L, Ganzevoort W, Richter J, Berger A, Brodszki J, Derks J, Mecacci F, Maruotti GM, Myklestad K, Lobmaier SM, Prefumo F, Klaritsch P, Calda P, Ebbing C, Frusca T, Raio L, Visser GHA, Krofta L, Cetin I, Ferrazzi E, Cesari E, Wolf H, Lees CC; TRUFFLE-2 Group. Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study. Ultrasound Obstet Gynecol. 2020 Aug;56(2):173-181. doi: 10.1002/uog.22125.
PubMed 32557921Crimmins S, Desai A, Block-Abraham D, Berg C, Gembruch U, Baschat AA. A comparison of Doppler and biophysical findings between liveborn and stillborn growth-restricted fetuses. Am J Obstet Gynecol. 2014 Dec;211(6):669.e1-10. doi: 10.1016/j.ajog.2014.06.022. Epub 2014 Jun 12.
PubMed 24931475Khalil AA, Morales-Rosello J, Morlando M, Hannan H, Bhide A, Papageorghiou A, Thilaganathan B. Is fetal cerebroplacental ratio an independent predictor of intrapartum fetal compromise and neonatal unit admission? Am J Obstet Gynecol. 2015 Jul;213(1):54.e1-54.e10. doi: 10.1016/j.ajog.2014.10.024. Epub 2014 Oct 18.
PubMed 25446667Bligh LN, Alsolai AA, Greer RM, Kumar S. Prelabor screening for intrapartum fetal compromise in low-risk pregnancies at term: cerebroplacental ratio and placental growth factor. Ultrasound Obstet Gynecol. 2018 Dec;52(6):750-756. doi: 10.1002/uog.18981.
PubMed 29227010Practice bulletin no. 145: antepartum fetal surveillance. Obstet Gynecol. 2014 Jul;124(1):182-192. doi: 10.1097/01.AOG.0000451759.90082.7b. No abstract available.
PubMed 24945455Manning FA. The fetal biophysical profile score: current status. Obstet Gynecol Clin North Am. 1990 Mar;17(1):147-62.
PubMed 2192316Hadlock FP, Harrist RB, Martinez-Poyer J. In utero analysis of fetal growth: a sonographic weight standard. Radiology. 1991 Oct;181(1):129-33. doi: 10.1148/radiology.181.1.1887021.
PubMed 1887021Baschat AA, Gembruch U. The cerebroplacental Doppler ratio revisited. Ultrasound Obstet Gynecol. 2003 Feb;21(2):124-7. doi: 10.1002/uog.20.
PubMed 12601831Kenyon S, Ullman R, Mori R, Whittle M. Care of healthy women and their babies during childbirth: summary of NICE guidance. BMJ. 2007 Sep 29;335(7621):667-8. doi: 10.1136/bmj.39322.703380.AD. No abstract available.
PubMed 17901518
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Late Fetal Growth Restriction in Uncomplicated Pregnancies Using Cerebroplacental Ratio: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04640467
- Acronym / sponsor ID
- CPR in late growth restriction
- Keywords
- Cerebroplacental ratio, Fetal growth restriction, Term pregnancy, Doppler ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 23 Nov 2020 (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.
To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies
Detailed description
Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as
- AC/EFW < 3rd centile Or at least two out of three of:
- AC/EFW < 10th centile
- AC/EFW crossing centiles >2 quartiles
- Cerebroplacental ratio (CPR) <5th centile or Umbilical artery Pusitility Index(UAPI )>95th centile FGR fetuses will not necessarily be SGA at delivery and vice versa. In fact, most SGA are likely to be 'constitutionally' small CPR is the ratio of the Middle cerebral artery Pulsatility Index (MCAPI) to (UAPI). The CPR gradually rises until around the 34th week and subsequently slowly declines until term. Its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord pH, admission to the intensive care unit and poor neurological outcomes The biophysical profile (BPP) abnormalities that characterize late FGR include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( CTG). It seems that BPP becomes abnormal only shortly before stillbirth .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Biophsical profile, Diagnostic Test: Cerebroplacental ratioWomen with uncomplicated singleton pregnancy who are planning a vaginal delivery, gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) and cephalic presentation |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women with uncomplicated singleton pregnancy who are planning a vaginal delivery. Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) with cephalic presentation
Key inclusion criteria (3 listed)
- •Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
Key exclusion criteria (5 listed)
- •Multiple pregnancy
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 |
|---|---|---|
| Biophsical profileAlso: BPPThere are five components measured during the biophysical examination. A score of 2 points is given for each component that meets criteria. The test is continued until all criteria are met or 30 minutes have elapsed. The points are then added for a possible maximum score of 10. A total score of 10 out of 10 or 8 out of 10 with normal fluid is considered normal. A score of 6 is considered equivocal, and a score of 4 or less is abnormal. | Diagnostic test | Pregnant women |
| Cerebroplacental ratioAlso: CPRCPR is the ratio of the Middle Cerebral Artery Pulsatility Index (MCA PI) to the Umbilical Artery Pulsatility Index (UA PI). The pulsatility indices will be measured from an automated trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The angle of insonation will be as close to zero degrees as possible. The UA PI will be recorded from a free-floating section of cord, and the MCA PI will be obtained from the proximal third of the vessel (10, 14). | Diagnostic test | Pregnant women |
Primary outcome
A composite of adverse neonatal outcomes
Time frame: Up to 48 hours After delivery
Apgar score ≤7 at 5 min or resuscitation with intubation, chest compressions or medication, admission to NICU ≥ 48 hours or hypoxic ischemic encephalopathy or cerebral palsy or stillbirth or neonatal death within 28 days
4 secondary outcomes
Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)
Time frame: At time of delivery
Demographic characteristics of the cohort
Time frame: Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
Estimated fetal weight
Time frame: At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
Birth weight
Time frame: Immediatly after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 30104317Sherrell H, Clifton V, Kumar S. Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: randomised controlled trial protocol. BMJ Open. 2018 Aug 13;8(8):e022567. doi: 10.1136/bmjopen-2018-022567.
- Background: PubMed 32738107Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.
- Background: PubMed 26909664Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.
- Background: PubMed 25346493Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.
- Background: PubMed 17721916Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.
- Background: PubMed 21343765Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Oros D, Gratacos E. Fetal brain Doppler to predict cesarean delivery for nonreassuring fetal status in term small-for-gestational-age fetuses. Obstet Gynecol. 2011 Mar;117(3):618-626. doi: 10.1097/AOG.0b013e31820b0884.
- Background: PubMed 32557921Stampalija T, Thornton J, Marlow N, Napolitano R, Bhide A, Pickles T, Bilardo CM, Gordijn SJ, Gyselaers W, Valensise H, Hecher K, Sande RK, Lindgren P, Bergman E, Arabin B, Breeze AC, Wee L, Ganzevoort W, Richter J, Berger A, Brodszki J, Derks J, Mecacci F, Maruotti GM, Myklestad K, Lobmaier SM, Prefumo F, Klaritsch P, Calda P, Ebbing C, Frusca T, Raio L, Visser GHA, Krofta L, Cetin I, Ferrazzi E, Cesari E, Wolf H, Lees CC; TRUFFLE-2 Group. Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study. Ultrasound Obstet Gynecol. 2020 Aug;56(2):173-181. doi: 10.1002/uog.22125.
- Background: PubMed 24931475Crimmins S, Desai A, Block-Abraham D, Berg C, Gembruch U, Baschat AA. A comparison of Doppler and biophysical findings between liveborn and stillborn growth-restricted fetuses. Am J Obstet Gynecol. 2014 Dec;211(6):669.e1-10. doi: 10.1016/j.ajog.2014.06.022. Epub 2014 Jun 12.
- Background: PubMed 25446667Khalil AA, Morales-Rosello J, Morlando M, Hannan H, Bhide A, Papageorghiou A, Thilaganathan B. Is fetal cerebroplacental ratio an independent predictor of intrapartum fetal compromise and neonatal unit admission? Am J Obstet Gynecol. 2015 Jul;213(1):54.e1-54.e10. doi: 10.1016/j.ajog.2014.10.024. Epub 2014 Oct 18.
- Background: PubMed 29227010Bligh LN, Alsolai AA, Greer RM, Kumar S. Prelabor screening for intrapartum fetal compromise in low-risk pregnancies at term: cerebroplacental ratio and placental growth factor. Ultrasound Obstet Gynecol. 2018 Dec;52(6):750-756. doi: 10.1002/uog.18981.
- Background: PubMed 24945455Practice bulletin no. 145: antepartum fetal surveillance. Obstet Gynecol. 2014 Jul;124(1):182-192. doi: 10.1097/01.AOG.0000451759.90082.7b. No abstract available.
- Background: PubMed 2192316Manning FA. The fetal biophysical profile score: current status. Obstet Gynecol Clin North Am. 1990 Mar;17(1):147-62.
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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.
Mariam Sobhy, MBBCH principal investigator
Assiut University
Ahmed Aboelhasan, MD principal investigator
Assiut University
Moustafa Gadalla, MD principal investigator
Assiut 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 Fetal Growth Retardation and Stillbirth, 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 3 inclusion and 5 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 13 Jan 2021. 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 Mariam Sobhy, MBBCH (+201095811120, rrrrgds83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of adverse neonatal outcomes (time frame: Up to 48 hours After delivery). 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 NCT04640467, which also lists 15 linked publications.
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 13 Jan 2021.