Total Placenta Previa Associated With the Placenta Accreta Spectrum.
- Conditions
- Maternal; Procedure
- Interventions
- Procedure: Peripartum total abdominal hysterectomy (p-TAH)Procedure: Cesarean Section (C/S)Other: Neonatal mortality
- Registration Number
- NCT06219564
- Lead Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 277
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI). Cesarean Section (C/S) 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. Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI). Peripartum total abdominal hysterectomy (p-TAH) 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. Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI). Cesarean Section (C/S) 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. Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI). Peripartum total abdominal hysterectomy (p-TAH) 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. Total placenta previa (t-PP) patients who underwent placental MRI (p-MRI). Neonatal mortality 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. Total placenta previa (t-PP) patients who did not undergo placental MRI (p-MRI). Neonatal mortality 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.
- Primary Outcome Measures
Name Time Method Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used. Assessed at the time of delivery. Binary measure indicating whether neonatal mortality occurred (yes/no).
Clinical risk factors affecting p-TAH in patients with t-PP undergoing p-MRI. Assessed during the peripartum period, within the first 2 days postpartum. Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening Assessed during the peripartum period, within the first two days postpartum. Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
- Secondary Outcome Measures
Name Time Method Peripartum Hysterectomy Occurrence Assessed during the peripartum period, within the first 2 days postpartum. 1. 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).
2. 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)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. Assessment of the ability of different variables (S1, S2, CCL, CCD) to indicate the need for peripartum hysterectomy.
Trial Locations
- Locations (1)
University of Health Sciences Adana City Training and Research Hospital, Department of Obstetrics and Gynecology
🇹🇷Adana, Yüreğir, Turkey