Abouda Hassine Saber, Aloui Haithem, Azouz Eya, Marzouk Sofiene Ben, Frikha Hatem, Hammami Rami, Minjli Sana, Hentati Rachid, Khila Mehdi, Chanoufi Badis Mohamed, Karoui Abir, Hayen Maghrebi
Tunis Medical Faculty, Tunis Centre for Maternity and Neonatal Care, Tunis El Manar University, Tunis, Tunisia (Abouda, Aloui, Azouz, Marzouk, Frikha, Hammami, Minjli, Hentati, Khila, Chanoufi, Karoui, and Hayen).
Department "C" of Gynaecology and Obstetrics, Tunis, Tunisia (Abouda, Aloui, Frikha, Hammami, Minjli, Hentati, Khila, Chanoufi, and Karoui).
AJOG Glob Rep. 2024 Dec 10;5(1):100430. doi: 10.1016/j.xagr.2024.100430. eCollection 2025 Feb.
The gold standard for treating the placenta accreta spectrum (PAS) is a cesarean hysterectomy, which harms fertility. Another conservative surgical approach allows the uterus to be preserved: one-step conservative surgery. We will compare these two approaches through the "CMNT PAS" study. Before this main study, we conducted a pilot study to determine the required sample size.
This pilot study, conducted over 31 months, included patients who underwent surgery for suspected PAS based on imaging findings. Participants were divided into the conservative surgery group (CSG: 6 patients) and the Caesarean Hysterectomy Group (control group [CG]: 6 patients). For the CSG, our team adapted the approach described in previous research by Palacios-Jaraquemada.
The primary objective of our study is to ascertain the appropriate sample size for our main investigation on the conservative surgical management of PAS. Concerning the primary outcome, the estimated amount of blood loss was lower in CSG compared to CG, although this difference was not statistically significant (1298.04±556 mL vs 891.051±348 mL, =.159). The mean decrease in hemoglobin (Δ Hb) was 2.8±1.3251 g/dL in the CG group compared to 1.933±1.0614 g/dL in the CSG group (=.240). The mean number of transfused red blood cell units was 3±3.2249 in the CG group and 1.5±1.64317 in the CSG group (=.334).
The estimated blood loss between the two groups is not statistically significant. The required sample size is 22 patients.
治疗胎盘植入谱系疾病（PAS）的金标准是剖宫产子宫切除术，这会损害生育能力。另一种保守手术方法可保留子宫：一步保守手术。我们将通过“CMNT PAS”研究比较这两种方法。在这项主要研究之前，我们进行了一项试点研究以确定所需的样本量。
这项为期31个月的试点研究纳入了根据影像学检查结果接受疑似PAS手术的患者。参与者分为保守手术组（CSG：6例患者）和剖宫产子宫切除组（对照组[CG]：6例患者）。对于CSG组，我们的团队采用了Palacios-Jaraquemada先前研究中描述的方法。
我们研究的主要目的是确定在PAS保守手术管理的主要研究中合适的样本量。关于主要结局，CSG组的估计失血量低于CG组，尽管这种差异无统计学意义（1298.04±556 mL对891.051±348 mL，P = 0.159）。CG组血红蛋白平均下降量（ΔHb）为2.8±1.3251 g/dL，而CSG组为1.933±1.0614 g/dL（P = 0.240）。CG组输注红细胞单位的平均数为3±3.2249，CSG组为1.5±1.64317（P = 0.334）。
两组之间的估计失血量无统计学意义。所需样本量为22例患者。
