Division of Obstetrics, Department of Pediatrics, Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Department of Gynecology and Obstetrics, Paule de Viguier Hospital, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
PLoS One. 2022 Jul 13;17(7):e0271065. doi: 10.1371/journal.pone.0271065. eCollection 2022.
Recent studies have shown that elective induction of labor versus expectant management after 39 weeks of pregnancy result in lower incidence of perinatal complications, while the proportion of cesarean deliveries remains stable, or even decreases. Still, evidence regarding collateral consequences of the potential increase of induction of labor procedures is still lacking. Also, the results of these studies must be carefully interpreted and thoroughly counter-balanced with women's thoughts and opinions regarding the active management of the last weeks of pregnancy. Therefore, it may be useful to develop a tool that aids in the decision-making process by differentiating women who will spontaneously go into labor from those who will require induction.
To develop a predictive model to calculate the probability of spontaneous onset of labor at term.
We designed a prospective national multicentric observational study including women enrolled at 39 weeks of gestation, carrying singleton pregnancies. After signing an informed consent form, several clinical, ultrasonographic, biophysical and biochemical variables will be collected by trained staff. If delivery has not occurred at 40 weeks of pregnancy, a second visit and evaluation will be performed. Prenatal care will be continued according to current hospital guidelines. Once recruitment is completed, the information gathered will be used to develop a logistic regression-based predictive model of spontaneous onset of labor between 39 and 41 weeks of gestation. A secondary exploration of the data collected at 40 weeks, as well as a survival analysis regarding time-to-delivery outcomes will also be performed. A total sample of 429 participants is needed for the expected number of events.
This study aims to develop a model which may help in the decision-making process during follow-up of the last weeks of pregnancy.
NCT05109247 (clinicaltrials.gov).
最近的研究表明，与妊娠 39 周后期待管理相比，选择性引产可降低围产期并发症的发生率，而剖宫产率保持稳定，甚至降低。然而，关于潜在增加引产程序的间接后果的证据仍然缺乏。此外，这些研究的结果必须仔细解释，并与女性对妊娠最后几周主动管理的想法和意见进行彻底权衡。因此，开发一种工具来辅助决策过程，区分自发分娩和需要引产的女性，可能会有所帮助。
开发一种预测模型来计算足月自发性分娩的概率。
我们设计了一项前瞻性全国多中心观察性研究，纳入 39 孕周单胎妊娠的孕妇。在签署知情同意书后，由经过培训的工作人员收集多项临床、超声、生物物理和生物化学变量。如果妊娠 40 周时仍未分娩，将进行第二次就诊和评估。产前护理将根据当前医院指南继续进行。一旦完成招募，将使用收集到的信息开发一个基于逻辑回归的 39 至 41 孕周自发性分娩预测模型。还将对 40 周收集的数据进行二次探索，并对分娩时间结局进行生存分析。预计需要 429 名参与者来获得预期的事件数量。
本研究旨在开发一种模型，以帮助在妊娠最后几周的随访过程中做出决策。
NCT05109247（clinicaltrials.gov）。
