Total Placenta Previa Associated With the Placenta Accreta Spectrum.

NCT06219564 | Completed

• 1 other identifier: SBU-OBGYN-SK-01
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.

Conditions

Maternal; Procedure

Keywords

magnetic resonance imaging; obstetric labor complications; placenta percreta; placenta previa; pregnancy complications

Outcome Measures

Primary Outcomes (3)

• Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening

  Binary measure indicating whether peripartum hysterectomy occurred (yes/no).

  Assessed during the peripartum period, within the first two days postpartum.

• Clinical risk factors affecting p-TAH in patients with t-PP undergoing p-MRI.

  Binary measure indicating whether peripartum hysterectomy occurred (yes/no).

  Assessed during the peripartum period, within the first 2 days postpartum.

• Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used.

  Binary measure indicating whether neonatal mortality occurred (yes/no).

  Assessed at the time of delivery.

Secondary Outcomes (2)

• The ROC analysis of the placental volume (S1 and S2 sectors), CCL, and CCD obtained from the p-MRI scan for indications of peripartum hysterectomy

  Assessed based on ROC analysis.

• Peripartum Hysterectomy Occurrence

  Assessed during the peripartum period, within the first 2 days postpartum.

Study Arms (2)

Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI).

ACTIVE COMPARATOR

The study compares clinical factors and p-MRI findings between two surgical procedures: Caesarean Section (C/S) and Peripartum Total Abdominal Hysterectomy (p-TAH). The study analyzes both univariate and multivariate associations with surgical procedures. This arm presents the results of a study assessing risk factors affecting peripartum hysterectomy in placenta previa patients, focusing on the impact of MRI screening. Peripartum hysterectomy (p-TAH) refers to the surgical removal of the uterus around the time of childbirth. The arm does not explicitly mention specific interventions to be administered. However, it provides information on clinical and p-MRI factors that might influence the surgical procedure (C/S or p-TAH) choice in placenta previa patients. The interventions, if any, would likely be based on assessing these risk factors and involve decisions on the type of surgery, additional procedures, or use of certain medical interventions based on the patient's condition.

Procedure: Peripartum total abdominal hysterectomy (p-TAH); Procedure: Cesarean Section (C/S); Other: Neonatal mortality

Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI).

ACTIVE COMPARATOR

The study compares clinical factors without p-MRI between two surgical procedures: Cesarean Section (C/S) and Peripartum Total Abdominal Hysterectomy (p-TAH). The study analyzes both univariate and multivariate associations with surgical procedures. This arm presents the results of a study assessing risk factors affecting peripartum hysterectomy (p-TAH) in placenta previa patients, focusing on the impact of clinical factors. The arm does not explicitly mention specific interventions to be administered. However, it provides information on clinical factors that might influence the surgical procedure (C/S or p-TAH) choice in placenta previa patients. The interventions, if any, would likely be based on assessing these risk factors and involve decisions on the type of surgery, additional procedures, or use of certain medical interventions based on the patient's condition.

Procedure: Peripartum total abdominal hysterectomy (p-TAH); Procedure: Cesarean Section (C/S); Other: Neonatal mortality

Interventions

Peripartum total abdominal hysterectomy (p-TAH) PROCEDURE

Peripartum total abdominal hysterectomy (cesarean hysterectomy) refers to a surgical procedure in which a woman undergoes both a cesarean section (C-section) and a hysterectomy simultaneously. Placenta Accreta, Increta, or Percreta: These are conditions where the placenta attaches too deeply to the uterine wall. In cases of severe attachment, it may be difficult to remove the placenta without causing excessive bleeding, and a hysterectomy may be required. Cesarean hysterectomy is a major surgical procedure involving significant medical expertise and coordination among healthcare professionals, including obstetricians and surgeons. The decision to perform a cesarean hysterectomy is usually made in emergency situations to address life-threatening complications.

Also known as: Cesarean hysterectomy

Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI).; Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI).

Cesarean Section (C/S) PROCEDURE

A cesarean section (C/S) involves making an incision in the abdominal wall and uterus to deliver a baby when a vaginal delivery is not feasible or safe. Total placenta previa refers to a condition where the placenta completely covers the opening of the cervix in the uterus. This condition can pose significant risks during pregnancy and childbirth, and it often necessitates a planned cesarean section (C/S) for delivery.

Also known as: C-section

Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI).; Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI).

Neonatal mortality OTHER

Neonatal mortality refers to the death of a newborn within the first 28 days of life. This period is divided into early neonatal mortality, which covers the first seven days of life, and late neonatal mortality, which extends from the eighth to the 28th day. Neonatal mortality is a critical measure of the health and well-being of infants and is often used to assess a population's overall health and healthcare systems. To reduce neonatal mortality, efforts are made to improve maternal healthcare, access to prenatal care, skilled attendance during childbirth, and the availability of neonatal healthcare services. Tracking and addressing factors contributing to neonatal mortality are crucial for improving the chances of survival of newborns and overall health outcomes.

Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI).; Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI).

Eligibility Criteria

• Age: 17 Years - 42 Years
• Gender Eligibility Details: singleton pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• th to 37th weeks of gestation
• Third trimester of pregnancy
• Pregnants had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or placental MRI (p-MRI).
• All singleton pregnancies in which t-PP extended to both the anterior and posterior uterine walls, resulting in complete coverage of the internal cervical os by the placenta

You may not qualify if:

• Any cases of low-lying/marginal placenta previa
• Preoperative hemoglobin level \< 9 g/dL
• Pregnant women with coagulation disorders
• Morbid obesity
• Multiple fetal pregnancies
• Individuals delivered before \< 27 weeks of gestation

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Adana City Training and Research Hospital, Department of Obstetrics and Gynecology

Adana, Yüreğir, 01230, Turkey (Türkiye)

Location

Related Publications (20)

• Huijgen QC, Gijsen AF, Hink E, Van Kesteren PJ. Cervical tourniquet in case of uncontrollable haemorrhage during caesarean section owing to a placenta accreta. BMJ Case Rep. 2013 Apr 22;2013:bcr2013009237. doi: 10.1136/bcr-2013-009237.

  PMID: 23608864 BACKGROUND

• Jha P, Poder L, Bourgioti C, Bharwani N, Lewis S, Kamath A, Nougaret S, Soyer P, Weston M, Castillo RP, Kido A, Forstner R, Masselli G. Society of Abdominal Radiology (SAR) and European Society of Urogenital Radiology (ESUR) joint consensus statement for MR imaging of placenta accreta spectrum disorders. Eur Radiol. 2020 May;30(5):2604-2615. doi: 10.1007/s00330-019-06617-7. Epub 2020 Feb 10.

  PMID: 32040730 RESULT

• Morel O, Collins SL, Uzan-Augui J, Masselli G, Duan J, Chabot-Lecoanet AC, Braun T, Langhoff-Roos J, Soyer P, Chantraine F; International Society for Abnormally Invasive Placenta (IS-AIP). A proposal for standardized magnetic resonance imaging (MRI) descriptors of abnormally invasive placenta (AIP) - From the International Society for AIP. Diagn Interv Imaging. 2019 Jun;100(6):319-325. doi: 10.1016/j.diii.2019.02.004. Epub 2019 Mar 8.

  PMID: 30853416 RESULT

• Palacios Jaraquemada JM, Bruno CH. Magnetic resonance imaging in 300 cases of placenta accreta: surgical correlation of new findings. Acta Obstet Gynecol Scand. 2005 Aug;84(8):716-24. doi: 10.1111/j.0001-6349.2005.00832.x.

  PMID: 16026395 RESULT

• Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.

  PMID: 31173360 RESULT

• Jauniaux E, Hussein AM, Fox KA, Collins SL. New evidence-based diagnostic and management strategies for placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2019 Nov;61:75-88. doi: 10.1016/j.bpobgyn.2019.04.006. Epub 2019 Apr 30.

  PMID: 31126811 RESULT

• Hecht JL, Baergen R, Ernst LM, Katzman PJ, Jacques SM, Jauniaux E, Khong TY, Metlay LA, Poder L, Qureshi F, Rabban JT 3rd, Roberts DJ, Shainker S, Heller DS. Classification and reporting guidelines for the pathology diagnosis of placenta accreta spectrum (PAS) disorders: recommendations from an expert panel. Mod Pathol. 2020 Dec;33(12):2382-2396. doi: 10.1038/s41379-020-0569-1. Epub 2020 May 15.

  PMID: 32415266 RESULT

• Hobson 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.

  PMID: 31227057 RESULT

• Romeo V, Verde F, Sarno L, Migliorini S, Petretta M, Mainenti PP, D'Armiento M, Guida M, Brunetti A, Maurea S. Prediction of placenta accreta spectrum in patients with placenta previa using clinical risk factors, ultrasound and magnetic resonance imaging findings. Radiol Med. 2021 Sep;126(9):1216-1225. doi: 10.1007/s11547-021-01348-6. Epub 2021 Jun 22.

  PMID: 34156592 RESULT

• Jauniaux 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.

  PMID: 29405319 RESULT

• Chen X, Shan R, Song Q, Wei X, Liu W, Wang G. Placenta percreta evaluated by MRI: correlation with maternal morbidity. Arch Gynecol Obstet. 2020 Mar;301(3):851-857. doi: 10.1007/s00404-019-05420-5. Epub 2020 Jan 4.

  PMID: 31903499 RESULT

• Gulati A, Anand R, Aggarwal K, Agarwal S, Tomer S. Ultrasound as a Sole Modality for Prenatal Diagnosis of Placenta Accreta Spectrum: Potentialities and Pitfalls. Indian J Radiol Imaging. 2021 Oct 19;31(3):527-538. doi: 10.1055/s-0041-1735864. eCollection 2021 Jul.

  PMID: 34790294 RESULT

• Bhide A, Laoreti A, Kaelin Agten A, Papageorghiou A, Khalil A, Uprichard J, Thilaganathan B, Chandraharan E. Lower uterine segment placental thickness in women with abnormally invasive placenta. Acta Obstet Gynecol Scand. 2019 Jan;98(1):95-100. doi: 10.1111/aogs.13422. Epub 2018 Aug 2.

  PMID: 29978457 RESULT

• Elmaraghy AM, Taha Fayed S, Abd ElHamid Ali M, Ali Hassanien M, Mohamed Mamdouh A. Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured by Ultrasound in Prediction of Placenta Accreta Spectrum in Patients with Placenta Previa. A Diagnostic Test Accuracy Study. Int J Womens Health. 2023 Feb 16;15:311-320. doi: 10.2147/IJWH.S399520. eCollection 2023.

  PMID: 36814526 RESULT

• Takahashi H, Matsubara S. Placental thickness measurement is difficult in some cases. Acta Obstet Gynecol Scand. 2019 Feb;98(2):264-265. doi: 10.1111/aogs.13443. Epub 2018 Sep 12. No abstract available.

  PMID: 30129148 RESULT

• Altal OF, Qudsieh S, Ben-Sadon A, Hatamleh A, Bataineh A, Halalsheh O, Amarin Z. Cervical tourniquet during cesarean section to reduce bleeding in morbidly adherent placenta: a pilot study. Future Sci OA. 2022 Mar 8;8(4):FSO789. doi: 10.2144/fsoa-2021-0087. eCollection 2022 Apr.

  PMID: 35369280 RESULT

• Matsuzaki S, Nagase Y, Takiuchi T, Kakigano A, Mimura K, Lee M, Matsuzaki S, Ueda Y, Tomimatsu T, Endo M, Kimura T. Antenatal diagnosis of placenta accreta spectrum after in vitro fertilization-embryo transfer: a systematic review and meta-analysis. Sci Rep. 2021 Apr 28;11(1):9205. doi: 10.1038/s41598-021-88551-7.

  PMID: 33911134 RESULT

• Salmanian B, Fox KA, Arian SE, Erfani H, Clark SL, Aagaard KM, Detlefs SE, Aalipour S, Espinoza J, Nassr AA, Gibbons WE, Shamshirsaz AA, Belfort MA, Shamshirsaz AA. In vitro fertilization as an independent risk factor for placenta accreta spectrum. Am J Obstet Gynecol. 2020 Oct;223(4):568.e1-568.e5. doi: 10.1016/j.ajog.2020.04.026. Epub 2020 Apr 30.

  PMID: 32360847 RESULT

• Vermey BG, Buchanan A, Chambers GM, Kolibianakis EM, Bosdou J, Chapman MG, Venetis CA. Are singleton pregnancies after assisted reproduction technology (ART) associated with a higher risk of placental anomalies compared with non-ART singleton pregnancies? A systematic review and meta-analysis. BJOG. 2019 Jan;126(2):209-218. doi: 10.1111/1471-0528.15227. Epub 2018 May 8.

  PMID: 29740927 RESULT

• Imafuku H, Tanimura K, Shi Y, Uchida A, Deguchi M, Terai Y. Clinical factors associated with a placenta accreta spectrum. Placenta. 2021 Sep 1;112:180-184. doi: 10.1016/j.placenta.2021.08.001. Epub 2021 Aug 5.

  PMID: 34375912 RESULT

MeSH Terms

Conditions

Obstetric Labor Complications; Placenta Accreta; Placenta Previa; Pregnancy Complications

Interventions

Cesarean Section; Infant Mortality

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Mortality; Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sadık Kükrer

  SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey

  PRINCIPAL INVESTIGATOR

• Sefa Arlıer

  SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey

  STUDY CHAIR

• Okan Dilek

  SBU Adana Training and Research Hospital, Department of Radiology, Adana, Turkey

  STUDY CHAIR

• Çağrı Gülümser

  Yuksek Ihtisas University, Department of Obstetrics and Gynecology, Ankara, Turkey

  STUDY DIRECTOR

• Işıl Adıgüzel

  SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two radiologists with at least ten years of experience, independently of each other, evaluated p-MRI scans of pregnant women diagnosed with t-PP without prior knowledge of the original reports.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 277 singleton pregnancies that met the inclusion criteria and were diagnosed with total placenta previa (t-PP) in the third trimester were divided into two groups according to whether a placental-MRI (p-MRI) was performed. Nevertheless, we explored whether pregnant women diagnosed with total placenta previa (t-PP), with or without a placental-MRI (p-MRI), needed to undergo peripartum-total abdominal hysterectomy (p-TAH) during cesarean section (C/S) due to the placenta accreta spectrum (PAS).

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 23, 2024
• Study Start: November 1, 2017
• Primary Completion: June 21, 2023
• Study Completion: June 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)