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临床试验/NCT04413019
NCT04413019已完成不适用

Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)

Ahmed Mohammed Selim1 个研究点 分布在 1 个国家目标入组 3,662 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,662
试验地点
1
主要终点
Take-home baby

研究概览

简要总结

This study is designed to compare efficacy & safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

详细描述

Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous

Aim of The Work: The aim of this study is to compare efficacy & safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

Patients & Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic & emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal & neonatal complications were recorded & moreover latency period, mode of delivery & preference of care were assessed

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
  • Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
  • Patients with placenta previa
  • Amniotic fluid pocket on ultrasound < 2x2 cm
  • Logistic problems interfering with follow-up
  • Inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°C)
  • Non-Dependable transportation

结局指标

主要结局

Take-home baby

时间窗: 2 years

this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby

次要结局

未报告次要终点

研究者

发起方
Ahmed Mohammed Selim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Mohammed Selim

ASelim

Ain Shams Maternity Hospital

研究点 (1)

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