Maternal; ProcedurePASNCT06219564
Total Placenta Previa Associated With the Placenta Accreta Spectrum.
A study testing Peripartum total abdominal hysterectomy (p-TAH), Cesarean Section (C/S) and Neonatal mortality in people with Maternal; Procedure, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa. Read more about this study
- Who is it for?
- Ages 17 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal; Procedure
- What is being tested?
- Peripartum total abdominal hysterectomy (p-TAH), Cesarean Section (C/S) and Neonatal mortality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 30 Jun 2023
- Phase
- Interventional
- 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 17 to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 27th 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Adana City Training and Research Hospital, Department of Obstetrics and Gynecology
Adana, Yüreğir, 01230
About this study
Official title: Diagnostic Accuracy of MRI to Predict Peripartum Hysterectomy and Neonatal Mortality in Total Placenta Previa: A Retrospective Cohort Study.
To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.
Read the detailed description
Study design and patients This study analyzed the outcomes of a cohort of 372 pregnant women diagnosed with PP over five years, from November 2017 to June 2023. The patient population for the study included women between the ages of 17 and 42 who were in their third trimester of pregnancy (27th to 37th weeks of gestation) and had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or p-MRI. The resulting cohort compared a final sample population of 277 singleton pregnant women with t-PP, which comprised 150 pregnant women who underwent antenatal p-MRI examinations in the third trimester and 127 pregnant women who did not undergo a p-MRI.
Standards of reference The study covered 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. Transvaginal and transabdominal USG were planned between 32 and 34 weeks for all patients who were followed up in our clinic due to t-PP and were scheduled to be delivered. The gestational ages of the participants were determined using the last menstrual date and crown-rump length (CRL) measurements from a first-trimester ultrasound. Two perinatologists with at least ten years of experience examined each patient's cd-USG for signs of PAS. Ultrasonographic signs identified included placental lacunae, placenta previa involving the cervix, loss of the clear zone, and bladder wall interruption.
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.
Definitive diagnosis and pathological reporting Pathological reports and approvals were granted according to a rigorous protocol involving at least two pathologists, each with a minimum of seven years of professional expertise in their field.
p-MRI image interpretations The assessment focused on analyzing the different positions of the atypical placenta in the lower uterine segment, including the anterior, posterior, anterolateral, and posterolateral locations. Precise measurements were taken to calculate the placental volume in the S1 and S2 sectors, cervical canal length, and cervical canal dilatation. Based on sagittal p-MRI scans, the placental invasion was classified into two main areas. Implementing a plane perpendicular to the upper bladder's axis facilitated the boundary of these sectors. The term S1 refers to the upper uterine segment that forms the part of the uterus that contacts the bladder's posterior wall. Likewise, the lower uterine segment, identified as S2, was formed in the lower posterior wall of the bladder. Radiologists conducted a sector-wise (S1 and S2) examination of the invasion topography, which allowed them to identify specific invasion locations, including parametrial and cervical involvement and bladder interruption.
Multidisciplinary team The operations of patients who gave birth due to PAS were performed by the same multidisciplinary team, which included perinatologists, gynecological and obstetric surgeons, gynecological oncologists, urologists, neonatologists, cardiovascular surgeons, anesthesiology and reanimation specialists, interventional radiologists, and allied health personnel with ten years of experience.
Scheduled surgery and preoperative preparations All participants in our study underwent cesarean births during the third trimester of pregnancy. Except for urgent situations, all scheduled preterm cesarean deliveries and p-TAH procedures were conducted during the gestational period of 34+0 to 36+6 weeks. Among the patients admitted to our clinic due to t-PP, surgical intervention was performed before the planned delivery date in cases of uterine contraction, the onset of vaginal bleeding, or unexpected medical indications for the mother and fetus.
Statistical Method and Power Analysis G*Power V. 3.1.9.6 estimated sample size. All p-MRI values of patients with and without PAS were compared in the reference study, and the difference was substantial. Using 95% confidence (1-α), 95% test power (1-β), d=0.8 effect size, and the two-way hypothesis, the study contained 84 cases, with a minimum of 42 in each group. The study included 155 cesarean sections and 122 TAH cases; post hoc analysis revealed a power of 99.9%. 16 Data were analyzed using IBM SPSS V23. ROC analysis determined the surgical procedure variable cut-off values. Univariate and multivariate binary logistic regression analyses examined independent surgical risk factors. Backward-Wald method was used for multivariate binary logistic regression. The analysis findings present mean ± standard deviation, median (minimum-maximum), and frequency (percentage) for quantitative and categorical variables. Intraclass correlation coefficients and Kappa (k) tests were conducted to assess intra- and inter-observer agreement reliability. The significance level was set at p<0.05.
- Conditions
- Maternal; Procedure
- Being tested
- Peripartum total abdominal hysterectomy (p-TAH), Cesarean Section (C/S), Neonatal mortality
- Keywords
- magnetic resonance imaging, obstetric labor complications, placenta percreta, placenta previa, pregnancy complications
- Medical subject headings
- Obstetric Labor Complications, Placenta Accreta, Placenta Previa, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripartum total abdominal hysterectomy (p-TAH)Procedure or surgery
Also called Cesarean hysterectomy
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.
Cesarean Section (C/S)Procedure or surgery
Also called C-section
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.
Neonatal mortalityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Peripartum total abdominal hysterectomy (p-TAH); Procedure: Cesarean Section (C/S); Other: Neonatal mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Measured: 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).
Measured: 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).
Measured: 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
Assessment of the ability of different variables (S1, S2, CCL, CCD) to indicate the need for peripartum hysterectomy.
Measured: Assessed based on ROC analysis.
Peripartum Hysterectomy Occurrence
- Participants and Procedures:
- Two surgery procedures are compared: Cesarean Section (C/S) and Total Abdominal Hysterectomy (TAH).
- The participants are divided into those who underwent C/S (155 cases) and TAH (122 cases).
- Risk factors that could potentially impact surgery type:
- Age of the mother
- Prior D\&C procedure
- Previous C-section delivery
- Vaginal delivery without complications
- Past myomectomy surgery
- Hysteroscopy procedure
- Weeks of gestational age
- Antepartum hemorrhage
- Fetal birth weight
- Blood product transfusions
- MRI screenings (S1, S2, CCL, CCD)
Measured: Assessed during the peripartum period, within the first 2 days postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Nov 2017
- Primary completion21 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Maternal; ProcedureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadık Kükrer, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Sadık Kükrer, Principal investigator, SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, TurkeySefa Arlıer, Study chair, SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, TurkeyOkan Dilek, Study chair, SBU Adana Training and Research Hospital, Department of Radiology, Adana, TurkeyÇağrı Gülümser, Study director, Yuksek Ihtisas University, Department of Obstetrics and Gynecology, Ankara, TurkeyIşıl Adıgüzel, Study chair, SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219564
- Sponsor's protocol ID
- SBU-OBGYN-SK-01
- Acronym
- PAS
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23608864Jha 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.
PubMed 32040730Morel 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.
PubMed 30853416Palacios 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.
PubMed 16026395Jauniaux 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.
PubMed 31173360Jauniaux 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.
PubMed 31126811Hecht 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.
PubMed 32415266Hobson 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 31227057Romeo 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.
PubMed 34156592Jauniaux 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 29405319Chen 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.
PubMed 31903499Gulati 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.
PubMed 34790294Bhide 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.
PubMed 29978457Elmaraghy 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.
PubMed 36814526Takahashi 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.
PubMed 30129148
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of MRI to Predict Peripartum Hysterectomy and Neonatal Mortality in Total Placenta Previa: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06219564
- Acronym / sponsor ID
- PAS / SBU-OBGYN-SK-01
- Conditions
- Maternal; Procedure
- Keywords
- magnetic resonance imaging, obstetric labor complications, placenta percreta, placenta previa, pregnancy complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Jan 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.
To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.
Detailed description
Study design and patients This study analyzed the outcomes of a cohort of 372 pregnant women diagnosed with PP over five years, from November 2017 to June 2023. The patient population for the study included women between the ages of 17 and 42 who were in their third trimester of pregnancy (27th to 37th weeks of gestation) and had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or p-MRI. The resulting cohort compared a final sample population of 277 singleton pregnant women with t-PP, which comprised 150 pregnant women who underwent antenatal p-MRI examinations in the third trimester and 127 pregnant women who did not undergo a p-MRI.
Standards of reference The study covered 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. Transvaginal and transabdominal USG were planned between 32 and 34 weeks for all patients who were followed up in our clinic due to t-PP and were scheduled to be delivered. The gestational ages of the participants were determined using the last menstrual date and crown-rump length (CRL) measurements from a first-trimester ultrasound. Two perinatologists with at least ten years of experience examined each patient's cd-USG for signs of PAS. Ultrasonographic signs identified included placental lacunae, placenta previa involving the cervix, loss of the clear zone, and bladder wall interruption.
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.
Definitive diagnosis and pathological reporting Pathological reports and approvals were granted according to a rigorous protocol involving at least two pathologists, each with a minimum of seven years of professional expertise in their field.
p-MRI image interpretations The assessment focused on analyzing the different positions of the atypical placenta in the lower uterine segment, including the anterior, posterior, anterolateral, and posterolateral locations. Precise measurements were taken to calculate the placental volume in the S1 and S2 sectors, cervical canal length, and cervical canal dilatation. Based on sagittal p-MRI scans, the placental invasion was classified into two main areas. Implementing a plane perpendicular to the upper bladder's axis facilitated the boundary of these sectors. The term S1 refers to the upper uterine segment that forms the part of the uterus that contacts the bladder's posterior wall. Likewise, the lower uterine segment, identified as S2, was formed in the lower posterior wall of the bladder. Radiologists conducted a sector-wise (S1 and S2) examination of the invasion topography, which allowed them to identify specific invasion locations, including parametrial and cervical involvement and bladder interruption.
Multidisciplinary team The operations of patients who gave birth due to PAS were performed by the same multidisciplinary team, which included perinatologists, gynecological and obstetric surgeons, gynecological oncologists, urologists, neonatologists, cardiovascular surgeons, anesthesiology and reanimation specialists, interventional radiologists, and allied health personnel with ten years of experience.
Scheduled surgery and preoperative preparations All participants in our study underwent cesarean births during the third trimester of pregnancy. Except for urgent situations, all scheduled preterm cesarean deliveries and p-TAH procedures were conducted during the gestational period of 34+0 to 36+6 weeks. Among the patients admitted to our clinic due to t-PP, surgical intervention was performed before the planned delivery date in cases of uterine contraction, the onset of vaginal bleeding, or unexpected medical indications for the mother and fetus.
Statistical Method and Power Analysis G*Power V. 3.1.9.6 estimated sample size. All p-MRI values of patients with and without PAS were compared in the reference study, and the difference was substantial. Using 95% confidence (1-α), 95% test power (1-β), d=0.8 effect size, and the two-way hypothesis, the study contained 84 cases, with a minimum of 42 in each group. The study included 155 cesarean sections and 122 TAH cases; post hoc analysis revealed a power of 99.9%. 16 Data were analyzed using IBM SPSS V23. ROC analysis determined the surgical procedure variable cut-off values. Univariate and multivariate binary logistic regression analyses examined independent surgical risk factors. Backward-Wald method was used for multivariate binary logistic regression. The analysis findings present mean ± standard deviation, median (minimum-maximum), and frequency (percentage) for quantitative and categorical variables. Intraclass correlation coefficients and Kappa (k) tests were conducted to assess intra- and inter-observer agreement reliability. The significance level was set at p<0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI). | Active comparator | Procedure: Peripartum total abdominal hysterectomy (p-TAH), Procedure: Cesarean Section (C/S), Other: Neonatal mortalityThe 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. |
| Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI). | Active comparator | Procedure: Peripartum total abdominal hysterectomy (p-TAH), Procedure: Cesarean Section (C/S), Other: Neonatal mortalityThe 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. |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 27th 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
Key exclusion criteria (6 listed)
- Any cases of low-lying/marginal placenta previa
- Preoperative hemoglobin level < 9 g/dL
- Pregnant women with coagulation disorders
- Morbid obesity
- Multiple fetal pregnancies
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 |
|---|---|---|
| Peripartum total abdominal hysterectomy (p-TAH)Also: Cesarean hysterectomyPeripartum 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. | Procedure or surgery | 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)Also: C-sectionA 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. | Procedure or surgery | 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 mortalityNeonatal 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. | Other | 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). |
Primary outcome
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening
Time frame: Assessed during the peripartum period, within the first two days postpartum.
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Clinical risk factors affecting p-TAH in patients with t-PP undergoing p-MRI.
Time frame: Assessed during the peripartum period, within the first 2 days postpartum.
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used.
Time frame: Assessed at the time of delivery.
Binary measure indicating whether neonatal mortality occurred (yes/no).
2 secondary outcomes
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
Time frame: Assessed based on ROC analysis.
Peripartum Hysterectomy Occurrence
Time frame: Assessed during the peripartum period, within the first 2 days postpartum.
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 23 Jan 2024.
- Background: PubMed 23608864Huijgen 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.
- Results publication: PubMed 32040730Jha 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.
- Results publication: PubMed 30853416Morel 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.
- Results publication: PubMed 16026395Palacios 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.
- Results publication: PubMed 31173360Jauniaux 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.
- Results publication: PubMed 31126811Jauniaux 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.
- Results publication: PubMed 32415266Hecht 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.
- Results publication: 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.
- Results publication: PubMed 34156592Romeo 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.
- Results publication: 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.
- Results publication: PubMed 31903499Chen 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.
- Results publication: PubMed 34790294Gulati 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.
- 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.
Sadık Kükrer principal investigator
SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
Sefa Arlıer study chair
SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
Okan Dilek study chair
SBU Adana Training and Research Hospital, Department of Radiology, Adana, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripartum total abdominal hysterectomy (p-TAH), Cesarean Section (C/S) and Neonatal mortality in people with Maternal; Procedure, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 23 Jan 2024. 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 Turkey (Türkiye). 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?
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening (time frame: Assessed during the peripartum period, within the first two days postpartum.). The study lists 3 primary outcomes in all. 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 NCT06219564, which also lists 20 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 23 Jan 2024.