Placenta PreviaNCT06589180
Clinical Outcomes of Placenta Previa - an Individualized Scoring System
An observational study of Placenta Previa, run by Assiut University.
Trial summary
The objective of the study is to develop a machine learning -based prediction model for patients with placenta previa . The model will be based on patient characteristics, clinical assessment, and disease features to predict disease course, prognosis and establish an individualized plan of care. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Placenta Previa
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2025to 4 May 2026
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation). Aged 18 years old or above.
Who may be able to join
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- Aged 18 years old or above. Diagnosed with PP, followed-up antenatally and delivered within the same center.
- Authorization to use anonymous patient data for research purposes
Who cannot join
- Inadequate documentation. Non-compliance to antenatal care. Previous 1 or more Cesarean deliveries. Previous uterine surgeries that approach the uterine cavity (myomectomy). Known untreated uterine septum. Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- Fetal major congenital anomalies
Trial locations and contacts
No sites are listed yet.
About this study
The objective of the study is to develop a machine learning -based prediction model for patients with placenta previa . The model will be based on patient characteristics, clinical assessment, and disease features to predict disease course, prognosis and establish an individualized plan of care. Individualized management plan comprises timing of delivery, mode of delivery, need for hospital admission, postpartum hemorrhage management plan, and perioperative care.
The primary outcome is to predict maternal complications, primarily major antepartum hemorrhage (APH), defined as blood loss of 50-1000 ml.
Read the detailed description
- Study settings: This multi-center study will invite at least 8 European-based tertiary centers. Data will be retrospectively collected from January 2018 to December 2023. with a total follow-up of at least 6 weeks postpartum. All women who will be diagnosed with PP during this period will be considered in the study.
- Inclusion Criteria:
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- Aged 18 years old or above.
- Diagnosed with PP, followed-up antenatally and delivered within the same center.
- Authorization to use anonymous patient data for research purposes.
Exclusion Criteria:
- Inadequate documentation.
- Non-compliance to antenatal care.
- Previous 1 or more Cesarean deliveries.
- Previous uterine surgeries that approach the uterine cavity (myomectomy).
- Known untreated uterine septum.
- Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- Fetal major congenital anomalies.
Data Collection A standardized data collection spreadsheet is designed for this study and will be available for all participating centers. The sheet will comprise drop lists for all nominal, ordinal and binary variables to ensure consistency. Target data will include patient demographics (age, parity, gestational age at diagnosis, mode of conception, body mass index at booking and at delivery, pregnancy interval), hemoglobin at booking, past medical and surgical history, and the presence of any current complications in pregnancy. Diagnostic information including placental location, distance from internal os, the presence of other placental abnormalities as well as diagnostic modality will be collected. Follow-up from the 32-week scan and any subsequent scans will be explored and further follow-up information including hemoglobin levels, bleeding episodes, need for transfusion, administration of steroids, fetal growth, and maternal and neonatal outcomes, will be reviewed, and collected.
Data sheets will be sent on completion to the primary investigators to review and inquire on any unclear entry prior to data cleaning and data analysis.
Secondary outcomes include prediction of need for antenatal transfusion, emergency cesarean delivery, and massive postpartum hemorrhage (defined as blood loss \> 2000 ml), and neonatal admission to neonatal intensive care unit (NICU).
- Conditions
- Placenta Previa
- Medical subject headings
- Placenta Previa
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergency cesarean section (CS)
CS that is indicated earlier than the elective planned date (36-37 weeks of gestation) due to bleeding or preterm labor
Measured: 22 weeks to 37 weeks of gestation
Secondary outcomes (1)
Peri-operative blood loss
Amount of blood loss in ml during and up to 24 hours after delivery as measured by suction device and gravimetric measures
Measured: Time between onset of cesarean section till 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Jan 2025 (estimated)
- Primary completion4 Feb 2026 (estimated)
- Study completion4 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Placenta PreviaStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle-Eastern College of Obstetricians and Gynecologists
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Middle-Eastern College of Obstetricians and Gynecologists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589180
- Sponsor's protocol ID
- PPISS
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jauniaux 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 30260097Silver RM, Fox KA, Barton JR, Abuhamad AZ, Simhan H, Huls CK, Belfort MA, Wright JD. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015 May;212(5):561-8. doi: 10.1016/j.ajog.2014.11.018. Epub 2014 Nov 20.
PubMed 25460838Bowman ZS, Eller AG, Bardsley TR, Greene T, Varner MW, Silver RM. Risk factors for placenta accreta: a large prospective cohort. Am J Perinatol. 2014 Oct;31(9):799-804. doi: 10.1055/s-0033-1361833. Epub 2013 Dec 12.
PubMed 24338130Ahn KH, Lee EH, Cho GJ, Hong SC, Oh MJ, Kim HJ. Anterior placenta previa in the mid-trimester of pregnancy as a risk factor for neonatal respiratory distress syndrome. PLoS One. 2018 Nov 2;13(11):e0207061. doi: 10.1371/journal.pone.0207061. eCollection 2018.
PubMed 30388184Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
PubMed 26244528Jing L, Wei G, Mengfan S, Yanyan H. Effect of site of placentation on pregnancy outcomes in patients with placenta previa. PLoS One. 2018 Jul 17;13(7):e0200252. doi: 10.1371/journal.pone.0200252. eCollection 2018.
PubMed 30016336Feng Y, Li XY, Xiao J, Li W, Liu J, Zeng X, Chen X, Chen KY, Fan L, Chen SH. Relationship between placenta location and resolution of second trimester placenta previa. J Huazhong Univ Sci Technolog Med Sci. 2017 Jun;37(3):390-394. doi: 10.1007/s11596-017-1745-5. Epub 2017 Jun 6.
PubMed 28585139Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
PubMed 30157787
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Placenta Previa - an Individualized Scoring System
- ClinicalTrials.gov ID
- NCT06589180
- Acronym / sponsor ID
- PPISS
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Middle-Eastern College of Obstetricians and Gynecologists
- Study start
- 4 Jan 2025 (estimated)
- Primary completion
- 4 Feb 2026 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The objective of the study is to develop a machine learning -based prediction model for patients with placenta previa . The model will be based on patient characteristics, clinical assessment, and disease features to predict disease course, prognosis and establish an individualized plan of care. Individualized management plan comprises timing of delivery, mode of delivery, need for hospital admission, postpartum hemorrhage management plan, and perioperative care.
The primary outcome is to predict maternal complications, primarily major antepartum hemorrhage (APH), defined as blood loss of 50-1000 ml.
Detailed description
- Study settings: This multi-center study will invite at least 8 European-based tertiary centers. Data will be retrospectively collected from January 2018 to December 2023. with a total follow-up of at least 6 weeks postpartum. All women who will be diagnosed with PP during this period will be considered in the study.
- Inclusion Criteria:
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- Aged 18 years old or above.
- Diagnosed with PP, followed-up antenatally and delivered within the same center.
- Authorization to use anonymous patient data for research purposes.
Exclusion Criteria:
- Inadequate documentation.
- Non-compliance to antenatal care.
- Previous 1 or more Cesarean deliveries.
- Previous uterine surgeries that approach the uterine cavity (myomectomy).
- Known untreated uterine septum.
- Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- Fetal major congenital anomalies.
Data Collection A standardized data collection spreadsheet is designed for this study and will be available for all participating centers. The sheet will comprise drop lists for all nominal, ordinal and binary variables to ensure consistency. Target data will include patient demographics (age, parity, gestational age at diagnosis, mode of conception, body mass index at booking and at delivery, pregnancy interval), hemoglobin at booking, past medical and surgical history, and the presence of any current complications in pregnancy. Diagnostic information including placental location, distance from internal os, the presence of other placental abnormalities as well as diagnostic modality will be collected. Follow-up from the 32-week scan and any subsequent scans will be explored and further follow-up information including hemoglobin levels, bleeding episodes, need for transfusion, administration of steroids, fetal growth, and maternal and neonatal outcomes, will be reviewed, and collected.
Data sheets will be sent on completion to the primary investigators to review and inquire on any unclear entry prior to data cleaning and data analysis.
Secondary outcomes include prediction of need for antenatal transfusion, emergency cesarean delivery, and massive postpartum hemorrhage (defined as blood loss \> 2000 ml), and neonatal admission to neonatal intensive care unit (NICU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation). Aged 18 years old or above.
Key inclusion criteria (3 listed)
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- Aged 18 years old or above. Diagnosed with PP, followed-up antenatally and delivered within the same center.
- Authorization to use anonymous patient data for research purposes
Key exclusion criteria (2 listed)
- Inadequate documentation. Non-compliance to antenatal care. Previous 1 or more Cesarean deliveries. Previous uterine surgeries that approach the uterine cavity (myomectomy). Known untreated uterine septum. Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- Fetal major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of emergency cesarean section (CS)
Time frame: 22 weeks to 37 weeks of gestation
CS that is indicated earlier than the elective planned date (36-37 weeks of gestation) due to bleeding or preterm labor
1 secondary outcome
Peri-operative blood loss
Time frame: Time between onset of cesarean section till 24 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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 25460838Silver RM, Fox KA, Barton JR, Abuhamad AZ, Simhan H, Huls CK, Belfort MA, Wright JD. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015 May;212(5):561-8. doi: 10.1016/j.ajog.2014.11.018. Epub 2014 Nov 20.
- Background: PubMed 24338130Bowman ZS, Eller AG, Bardsley TR, Greene T, Varner MW, Silver RM. Risk factors for placenta accreta: a large prospective cohort. Am J Perinatol. 2014 Oct;31(9):799-804. doi: 10.1055/s-0033-1361833. Epub 2013 Dec 12.
- Background: PubMed 30388184Ahn KH, Lee EH, Cho GJ, Hong SC, Oh MJ, Kim HJ. Anterior placenta previa in the mid-trimester of pregnancy as a risk factor for neonatal respiratory distress syndrome. PLoS One. 2018 Nov 2;13(11):e0207061. doi: 10.1371/journal.pone.0207061. eCollection 2018.
- Background: PubMed 26244528Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
- Background: PubMed 30016336Jing L, Wei G, Mengfan S, Yanyan H. Effect of site of placentation on pregnancy outcomes in patients with placenta previa. PLoS One. 2018 Jul 17;13(7):e0200252. doi: 10.1371/journal.pone.0200252. eCollection 2018.
- Background: PubMed 28585139Feng Y, Li XY, Xiao J, Li W, Liu J, Zeng X, Chen X, Chen KY, Fan L, Chen SH. Relationship between placenta location and resolution of second trimester placenta previa. J Huazhong Univ Sci Technolog Med Sci. 2017 Jun;37(3):390-394. doi: 10.1007/s11596-017-1745-5. Epub 2017 Jun 6.
- Background: PubMed 30157787Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa, run by Assiut University.
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 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sherif Shazly (+447554480388, admin@Mcog-obgyn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergency cesarean section (CS) (time frame: 22 weeks to 37 weeks of gestation). 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 NCT06589180, which also lists 8 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 19 Sep 2024.