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NCT Number: NCT06589180

Clinical Outcomes of Placenta Previa - an Individualized Scoring System

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.

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Key information

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Peri-operative blood loss

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

    Amount of blood loss in ml during and up to 24 hours after delivery as measured by suction device and gravimetric measures

Study contacts

Contact information is provided by the study sponsor or research team.

Manar AHMED

CONTACT

[email protected]

+201128793950

Sherif Shazly

CONTACT

[email protected]

+447554480388

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Middle-Eastern College of Obstetricians and Gynecologists

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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