NCT04827433招募中不适用
Mode of Delivery in Women With Low-lying Placenta: an Italian Multicentre Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,550
- 试验地点
- 17
- 主要终点
- Incidence of vaginal delivery and urgent cesarean section
研究概览
简要总结
Multicentre study; observational, longitudinal prospective, case-control
详细描述
This is a new protocol to evaluate the mode of birth in women with a low-lying placenta. In particular, we intend to propose a vaginal birth in women having a low-lying placenta with a distance between the inferior placental edge and the internal cervical os, called internal-os-distance (IOD) of > 5 mm, as assessed in the late III trimester using transvaginal sonography.
Duration of the study:
- Duration of the study: 54 months
- Duration of enrollment: 42 months
- Duration of follow-up completion of enrolled cases: 6 months
- Duration of data analysis: 6 months
Study Design:
During the II trimester scan, all women presenting a placenta located in the lower uterine segment will undergo evaluation by Transvaginal Sonography (TVS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 18
- •Women with placenta previa or low-lying placenta confirmed by TVS at 19-23 6/7 weeks of gestation.
- •Women attending Maternity Triage with vaginal bleeding at < 32 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery.
- •Women with a normally located placenta at the II trimester ultrasound scan, at 19-23 6/7 week of gestation (control group)
- •Single pregnancy
- •Signature of the informed consent to participate in the study
- •Note: Women of the "control group" will be recruited in a 1:3 ratio. After the inclusion of 1 case, 3 women with a normally located placenta will be recruited, according to the parity of the woman representing the case (e.g.: 1 CASE= nulliparous woman, 3 CONTROLS= 3 nulliparous women).
排除标准
- •Suspected or confirmed invasive placentation (i.e., placenta accreta)
- •Vaginal bleeding requiring emergency delivery
- •Inability to meet the conditions set out in the study protocol
结局指标
主要结局
Incidence of vaginal delivery and urgent cesarean section
时间窗: Until the end of the study (approximately 54 months).
Rate of vaginal birth and emergency cesarean section in labor due to vaginal bleeding
次要结局
- Morbidity associated with the various groups of placental distance studied with the intrapartum hemorrhage incidence.(Until the end of the study (approximately 54 months).)
- Frequency of resolution of placenta previa or low-lying(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance through the severe postpartum hemorrhage incidence.(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance associated with the admission to Intensive Care Unit (ICU)(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance described by the preterm bith incidence(Until the end of the study (approximately 54 months).)
- Frequency of ultrasound visualization of the marginal breast in low-lying placentas and other variables(Until the end of the study (approximately 54 months).)
- Refusal of elective caesarean section(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance analyzed by the antepartum hemorrhage incidence.(Until the end of the study (approximately 54 months).)
- Placental migration speed and its correlation with different variables(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance described through the preterm incidence less than 32 weeks.(Until the end of the study (approximately 54 months).)
- Morbidity associated with the various groups of placental distance according to the neonatal admission to ICU(Until the end of the study (approximately 54 months).)
研究者
研究点 (17)
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