An interventional study of Peripartum total abdominal hysterectomy (p-TAH) and Cesarean Section (C/S) in Maternal; Procedure, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 17 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Diagnostic
To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 277 is above the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Time frame: 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).
Time frame: 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).
Time frame: Assessed at the time of delivery.
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.
Time frame: Assessed based on ROC analysis.
Peripartum Hysterectomy Occurrence
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)
Time frame: Assessed during the peripartum period, within the first 2 days postpartum.
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Obstetric Labor Complications →
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital