Placenta AccretaNCT04911322
Pulmonary Artery Doppler and Neonatal Outcome in Placenta Accreta Spectrum Patients
An observational study of Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2021to 1 Sep 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 18 to 42 years
- Women only
- Adult
Study population: Women with placenta accreta spectrum with singleton pregnancy undergoing cesarean delivery in Kasr Alainy hospital.
Who may be able to join
- Age: 18-42 years old
- Patients who will be diagnosed with placenta accreta spectrum preoperatively according to (ACOG 2018), (Jauniaux et al., 2018 a), (Jauniaux et al., 2018 b)
- Those who will undergo elective or emergency cesarean.
- With gestational age: 34 0/7 - 38 6/7 weeks
- Under the effect of general anesthesia
Who cannot join
- Multifetal pregnancy
- Intrauterine fetal death
- Intrauterine growth restriction (IUGR) which is defined as a rate of fetal growth that is less than normal for the growth potential of that specific infant
- Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
- Pregnancy induced hypertension defined as either systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. It is classified as one of four conditions: preexisting hypertension, gestational hypertension, preeclampsia, preexisting hypertension with superimposed preeclampsia
- Premature rupture of membranes
Show all 13Show fewer
- BMI above 40 due to technical difficulties to obtain accurate measures
- Narcotic usage during anesthesia before fetal delivery
- Major congenital fetal anomalies whether diagnosed before or after delivery
- Maternal fever more than 37.4 degree
- Emergent cases presenting with fetal distress (bradycardia will be defined as fetal heart rate < 110 beat per minute)
- Patients who have not completed the course of antenatal corticosteroids according to (RCOG 2010).
- Intraoperative spontaneous separation of the placenta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Pulmonary Artery Doppler And Other Ultrasonographic Markers With Neonatal Outcome In Placenta Accreta Spectrum Patients
To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.
Read the detailed description
The increasing rates of cesarean section has led to several fold increase in the incidence of placenta accreta spectrum in the last three or four decades.
Placenta accreta spectrum (PAS) disorders is the term used to describe a variety of pregnancy complications resulting from abnormal placental implantation that is accompanied by deficiency of the uterine wall.
Placenta accreta spectrum includes placenta accreta, placenta increta, placenta percreta.
Placenta accreta spectrum is one of the devastating obstetric complications owing to massive hemorrhage encountered during manual removal of the placenta to preserve the uterus or even the need for peripartum hysterectomy, need for massive blood transfusion, maternal intensive care admission and maternal mortality.
Complications related to blood loss are lower in elective compared to emergency deliveries. This has led to the scheduling of surgical interventions with planned late preterm (35-36 weeks) or early term (37 weeks) delivery as a mechanism to avoid the need for emergency surgery. According to the RCOG guidelines, planned delivery at 35 0/7- 36 0/7 weeks of gestation provides the best chance between fetal maturity and the risk of unscheduled delivery while ACOG recommends 34 0/7- 35 6/7.
Early attempts have been made to predict fetal maturity on the basis antenatal sonographic parameters including lung characteristics, bowel pattern, placental grading (which cannot be relied upon in patients with placenta accreta spectrum), and the presence or absence of intraamniotic particles (vernix caseosa).
Additionally, the epiphyseal ossification centers appear and enlarge at variable rates but in a predictable sequence: the distal femoral epiphysis (DFE) appears prior to the proximal tibial epiphysis (PTE), which precedes the appearance of the proximal humeral epiphysis (PHE). The PTE grows more rapidly than does the DFE so that, as gestation progresses, the size of the PTE approaches that of the DFE.
More recently, fetal pulmonary artery Doppler has been used to predict neonatal RDS. It was found that an elevated acceleration-to-ejection time ratio was significantly associated with neonatal RDS. However such indices cannot be generalized in all cases, especially those with placenta accreta spectrum who have excessive placental shunting affecting fetoplacental circulation resistance.
To the best of our knowledge, no available studies have correlated signs of maturity of the fetus detected by ultrasound with neonatal outcomes in the late preterm and early term in such patients. Presence of such signs of maturity can aid the obstetrician to choose the most appropriate timing for termination especially in low income countries who have limited access to NICUs.
Being cost effective and non invasive, ultrasonography is used as a routine obstetric scanning tool. This study will help determine the utility of ultrasound in assessing the fetal lung maturity in such patients.
- Conditions
- Placenta Accreta
- Being tested
- ultrasonography
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
A full obstetric ultrasound scan will be performed to assess signs of placental invasion, to document fetal biometry, estimated fetal weight, amniotic fluid index, assess fetal lung maturity parameters as pulmonary artery Doppler waveforms, amniotic fluid free floating particles, bowel echogenicity, fetal epiphyseal ossific centers, liver/lung echogenicity and kidney length.
Pulmonary artery Doppler: Fetal echocardiography will be done. Pulmonary artery Doppler flow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time ratio will be measured in the main pulmonary artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.
(At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
Measured: Baseline
Secondary outcomes (11)
The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.
The PI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Measured: Baseline
The resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
RI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Measured: Baseline
The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
S/D will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Measured: Baseline
The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
PSV will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Measured: Baseline
Optimal timing of delivery in PAS for best neonatal outcome
according to the neonatal outcome, the best timing for delivery will be determined
Measured: baseline
Optimal timing of delivery in PAS for best maternal outcome
according to the maternal mortality and morbidity rate, the best timing for delivery will be obtained
Measured: baseline
percent of women who will undergo cesarean hysterectomy versus conservative management
surgical management options; cesarean hysterectomy and conservative management will be recorded
Measured: baseline
The need for blood transfusion
The need for replacement by blood or blood products will be recorded
Measured: baseline
Maternal morbidity in the form of organ injury will be recorded
Organ injury will be recorded
Measured: baseline
The need for peripartum hysterectomy will be recorded
The need for peripartum hysterectomy either in cases of abnormally invasive placenta or in cases of abnormally adherent placenta in which the placenta separated but with uncontrollable bleeding
Measured: Baseline
Maternal mortality rate
Rate of maternal mortality will be recorded
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Aug 2021
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran Amin, Cairo University
- Investigators
- Ahmed H El Sawaf, MD, Study director, Cairo UniversityTarek M El Husseiny, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911322
- Sponsor's protocol ID
- PAS disorders
- Status last verified
- Sep 2022
- First submitted
- 23 May 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: Placenta Accreta Spectrum. Obstet Gynecol. 2018 Dec;132(6):e259-e275. doi: 10.1097/AOG.0000000000002983.
PubMed 30461695Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.
PubMed 15765129Hobson SR, Kingdom JC, Murji A, Windrim RC, Carvalho JCA, Singh SS, Ziegler C, Birch C, Frecker E, Lim K, Cargill Y, Allen LM. No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders. J Obstet Gynaecol Can. 2019 Jul;41(7):1035-1049. doi: 10.1016/j.jogc.2018.12.004.
PubMed 31227057Creanga AA, Bateman BT, Butwick AJ, Raleigh L, Maeda A, Kuklina E, Callaghan WM. Morbidity associated with cesarean delivery in the United States: is placenta accreta an increasingly important contributor? Am J Obstet Gynecol. 2015 Sep;213(3):384.e1-11. doi: 10.1016/j.ajog.2015.05.002. Epub 2015 May 5.
PubMed 25957019Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.
PubMed 19191778Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.
PubMed 17890709Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
PubMed 30260097Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
PubMed 29405319Kim SM, Park JS, Norwitz ER, Hwang EJ, Kang HS, Park CW, Jun JK. Acceleration time-to-ejection time ratio in fetal pulmonary artery predicts the development of neonatal respiratory distress syndrome: a prospective cohort study. Am J Perinatol. 2013 Nov;30(10):805-12. doi: 10.1055/s-0032-1333132. Epub 2013 Jan 4.
PubMed 23292917Mahony BS, Bowie JD, Killam AP, Kay HH, Cooper C. Epiphyseal ossification centers in the assessment of fetal maturity: sonographic correlation with the amniocentesis lung profile. Radiology. 1986 May;159(2):521-4. doi: 10.1148/radiology.159.2.3515425.
PubMed 3515425Mammaro A, Carrara S, Cavaliere A, Ermito S, Dinatale A, Pappalardo EM, Militello M, Pedata R. Hypertensive disorders of pregnancy. J Prenat Med. 2009 Jan;3(1):1-5.
PubMed 22439030McCowan LM, Figueras F, Anderson NH. Evidence-based national guidelines for the management of suspected fetal growth restriction: comparison, consensus, and controversy. Am J Obstet Gynecol. 2018 Feb;218(2S):S855-S868. doi: 10.1016/j.ajog.2017.12.004.
PubMed 29422214Seoud MA, Nasr R, Berjawi GA, Zaatari GS, Seoud TM, Shatila AS, Mirza FG. Placenta accreta: Elective versus emergent delivery as a major predictor of blood loss. J Neonatal Perinatal Med. 2017;10(1):9-15. doi: 10.3233/NPM-1622.
PubMed 28304318Spong CY, Mercer BM, D'Alton M, Kilpatrick S, Blackwell S, Saade G. Timing of indicated late-preterm and early-term birth. Obstet Gynecol. 2011 Aug;118(2 Pt 1):323-333. doi: 10.1097/AOG.0b013e3182255999.
PubMed 21775849
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pulmonary Artery Doppler And Other Ultrasonographic Markers With Neonatal Outcome In Placenta Accreta Spectrum Patients
- ClinicalTrials.gov ID
- NCT04911322
- Acronym / sponsor ID
- PAS disorders
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 3 Jun 2021 (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 correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.
Detailed description
The increasing rates of cesarean section has led to several fold increase in the incidence of placenta accreta spectrum in the last three or four decades.
Placenta accreta spectrum (PAS) disorders is the term used to describe a variety of pregnancy complications resulting from abnormal placental implantation that is accompanied by deficiency of the uterine wall.
Placenta accreta spectrum includes placenta accreta, placenta increta, placenta percreta.
Placenta accreta spectrum is one of the devastating obstetric complications owing to massive hemorrhage encountered during manual removal of the placenta to preserve the uterus or even the need for peripartum hysterectomy, need for massive blood transfusion, maternal intensive care admission and maternal mortality.
Complications related to blood loss are lower in elective compared to emergency deliveries. This has led to the scheduling of surgical interventions with planned late preterm (35-36 weeks) or early term (37 weeks) delivery as a mechanism to avoid the need for emergency surgery. According to the RCOG guidelines, planned delivery at 35 0/7- 36 0/7 weeks of gestation provides the best chance between fetal maturity and the risk of unscheduled delivery while ACOG recommends 34 0/7- 35 6/7.
Early attempts have been made to predict fetal maturity on the basis antenatal sonographic parameters including lung characteristics, bowel pattern, placental grading (which cannot be relied upon in patients with placenta accreta spectrum), and the presence or absence of intraamniotic particles (vernix caseosa).
Additionally, the epiphyseal ossification centers appear and enlarge at variable rates but in a predictable sequence: the distal femoral epiphysis (DFE) appears prior to the proximal tibial epiphysis (PTE), which precedes the appearance of the proximal humeral epiphysis (PHE). The PTE grows more rapidly than does the DFE so that, as gestation progresses, the size of the PTE approaches that of the DFE.
More recently, fetal pulmonary artery Doppler has been used to predict neonatal RDS. It was found that an elevated acceleration-to-ejection time ratio was significantly associated with neonatal RDS. However such indices cannot be generalized in all cases, especially those with placenta accreta spectrum who have excessive placental shunting affecting fetoplacental circulation resistance.
To the best of our knowledge, no available studies have correlated signs of maturity of the fetus detected by ultrasound with neonatal outcomes in the late preterm and early term in such patients. Presence of such signs of maturity can aid the obstetrician to choose the most appropriate timing for termination especially in low income countries who have limited access to NICUs.
Being cost effective and non invasive, ultrasonography is used as a routine obstetric scanning tool. This study will help determine the utility of ultrasound in assessing the fetal lung maturity in such patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with placenta accreta spectrum with singleton pregnancy undergoing cesarean delivery in Kasr Alainy hospital.
Key inclusion criteria (5 listed)
- Age: 18-42 years old
- Patients who will be diagnosed with placenta accreta spectrum preoperatively according to (ACOG 2018), (Jauniaux et al., 2018 a), (Jauniaux et al., 2018 b)
- Those who will undergo elective or emergency cesarean.
- With gestational age: 34 0/7 - 38 6/7 weeks
- Under the effect of general anesthesia
Key exclusion criteria (13 listed)
- Multifetal pregnancy
- Intrauterine fetal death
- Intrauterine growth restriction (IUGR) which is defined as a rate of fetal growth that is less than normal for the growth potential of that specific infant
- Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
- Pregnancy induced hypertension defined as either systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. It is classified as one of four conditions: preexisting hypertension, gestational hypertension, preeclampsia, preexisting hypertension with superimposed preeclampsia
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 |
|---|---|---|
| ultrasonographyA full obstetric ultrasound scan will be performed to assess signs of placental invasion, to document fetal biometry, estimated fetal weight, amniotic fluid index, assess fetal lung maturity parameters as pulmonary artery Doppler waveforms, amniotic fluid free floating particles, bowel echogenicity, fetal epiphyseal ossific centers, liver/lung echogenicity and kidney length. Pulmonary artery Doppler: Fetal echocardiography will be done. Pulmonary artery Doppler flow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time ratio will be measured in the main pulmonary artery. | Device | – |
Primary outcome
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.
Time frame: Baseline
(At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
11 secondary outcomes
The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.
Time frame: Baseline
The resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time frame: Baseline
The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time frame: Baseline
The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time frame: Baseline
Optimal timing of delivery in PAS for best neonatal outcome
Time frame: baseline
Optimal timing of delivery in PAS for best maternal outcome
Time frame: baseline
percent of women who will undergo cesarean hysterectomy versus conservative management
Time frame: baseline
The need for blood transfusion
Time frame: baseline
Maternal morbidity in the form of organ injury will be recorded
Time frame: baseline
The need for peripartum hysterectomy will be recorded
Time frame: Baseline
Maternal mortality rate
Time frame: Baseline
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 7 Sep 2022.
- Background: PubMed 30461695American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: Placenta Accreta Spectrum. Obstet Gynecol. 2018 Dec;132(6):e259-e275. doi: 10.1097/AOG.0000000000002983.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 15765129Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.
- Background: PubMed 31227057Hobson SR, Kingdom JC, Murji A, Windrim RC, Carvalho JCA, Singh SS, Ziegler C, Birch C, Frecker E, Lim K, Cargill Y, Allen LM. No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders. J Obstet Gynaecol Can. 2019 Jul;41(7):1035-1049. doi: 10.1016/j.jogc.2018.12.004.
- Background: PubMed 25957019Creanga AA, Bateman BT, Butwick AJ, Raleigh L, Maeda A, Kuklina E, Callaghan WM. Morbidity associated with cesarean delivery in the United States: is placenta accreta an increasingly important contributor? Am J Obstet Gynecol. 2015 Sep;213(3):384.e1-11. doi: 10.1016/j.ajog.2015.05.002. Epub 2015 May 5.
- Background: PubMed 19191778Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.
- Background: PubMed 17890709Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.
- Background: PubMed 30260097Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
- Background: PubMed 29405319Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
- Background: PubMed 23292917Kim SM, Park JS, Norwitz ER, Hwang EJ, Kang HS, Park CW, Jun JK. Acceleration time-to-ejection time ratio in fetal pulmonary artery predicts the development of neonatal respiratory distress syndrome: a prospective cohort study. Am J Perinatol. 2013 Nov;30(10):805-12. doi: 10.1055/s-0032-1333132. Epub 2013 Jan 4.
- Background: PubMed 3515425Mahony BS, Bowie JD, Killam AP, Kay HH, Cooper C. Epiphyseal ossification centers in the assessment of fetal maturity: sonographic correlation with the amniocentesis lung profile. Radiology. 1986 May;159(2):521-4. doi: 10.1148/radiology.159.2.3515425.
- Background: PubMed 22439030Mammaro A, Carrara S, Cavaliere A, Ermito S, Dinatale A, Pappalardo EM, Militello M, Pedata R. Hypertensive disorders of pregnancy. J Prenat Med. 2009 Jan;3(1):1-5.
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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.
Ahmed H El Sawaf, MD study director
Cairo University
Tarek M El Husseiny, MD study chair
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 Placenta Accreta, run by Cairo 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 13 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 7 Sep 2022. 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?
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome. (time frame: Baseline). 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 NCT04911322, which also lists 18 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 7 Sep 2022.