Clinical Outcomes of Placenta Previa - an Individualized Scoring System

NCT06589180 | Not Yet Recruiting

• 1 other identifier: PPISS
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• 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

  22 weeks to 37 weeks of gestation

Secondary Outcomes (1)

• Peri-operative blood loss

  Time between onset of cesarean section till 24 hours after the procedure

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead
• Middle-Eastern College of Obstetricians and Gynecologists: collaborator

Related Publications (8)

• 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.

  PMID: 30260097 BACKGROUND

• Silver 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.

  PMID: 25460838 BACKGROUND

• Bowman 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.

  PMID: 24338130 BACKGROUND

• Ahn 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.

  PMID: 30388184 BACKGROUND

• Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.

  PMID: 26244528 BACKGROUND

• Jing 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.

  PMID: 30016336 BACKGROUND

• Feng 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.

  PMID: 28585139 BACKGROUND

• Sanad 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.

  PMID: 30157787 BACKGROUND

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Sherif Shazly

CONTACT

+447554480388; admin@Mcog-obgyn.org

Manar AHMED

CONTACT

+201128793950; Manar.mahran.mcog@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Middle-Eastern college of Obstetricians and Gynecologists, senior clinical fellow, principal investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: January 4, 2025
• Primary Completion: February 4, 2026
• Study Completion: May 4, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share