Prevalence of Psychological Disorders After Immediate Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,298
- 试验地点
- 2
- 主要终点
- prevalence of depression
研究概览
简要总结
The objective of this cross-sectional study is to assess the prevalence of depression at 2 months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential serious consequences of PPH may lead to a greater number of psychological disorders in these women than in women without PPH.
详细描述
Study design: This repeated, cross-sectional, descriptive and etiological single-center study will take place within a cohort of women giving birth at the Clermont-Ferrand University Hospital Center (Psyche 1), and a cohort of their partners (psyche 2).
Principal endpoint: The prevalence of depression, measured by the Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11.
Study plan and procedures:
Psyche 1:
For each woman with a PPH (exposed), 2 women without PPH (not exposed) will be included: the women who gave birth immediately before and immediate after her. If one of these 2 unexposed women eligible for the unexposed group also has a postpartum hemorrhage, another woman immediately just before or after the woman with PPH will be included. The PPH will be managed according to the national guidelines issued in December 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
open
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
- •For the women:
- •Inclusion criteria:
- •women who gave birth at a term ≥ 22 weeks' gestation or, if the term is unknown, to a fetus with a birth weight ≥ 500 g),
- •regardless of the type of delivery (vaginal or cesarean),
- •regardless of parity or fetal presentation,
- •and regardless of type of pregnancy (singleton or multiple).
- •and affiliated with French CNAMTS (salaried worker) health insurance.
排除标准
- •Women who are:
- •who do not understand French,
- •who refuse to participate (did not sign consent),
- •and who did not give birth at the Clermont-Ferrand University Hospital Center maternity unit and were secondarily transferred there postpartum.
- •For the partners:
- •Inclusion criteria:
- •Partner of a woman who gave birth at a term ≥ 22 weeks of gestation or, if the term is unknown, to a fetus with a birth weight ≥ 500 g),
- •Regardless of the type of delivery (vaginal or cesarean),
- •Regardless of parity and fetal presentation,
- •And regardless of type of pregnancy (singleton or multiple),
- •And both partners are affiliated with French CNAMTS (salaried worker) health insurance.
- •Exclusion criteria:
- •Partner of a woman who gave birth at a term < 22 weeks of gestation or, if the term is unknown, to a fetus with a birth weight < 500 g),
- •Partner who does not understand French,
- •Who refuses to participate (does not sign consent),
- •Partner who is a minor,
- •Protected adult,
- •Partner not present at the maternity ward (woman is divorced, separated, has no partner, or the partner is abroad or in prison or died during pregnancy),
- •And partners of women who gave birth outside the UHC and was transferred to it only secondarily in the postpartum period.
研究组 & 干预措施
women in the exposed group with a hemorrhage
干预措施: • The Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11. (Behavioral)
women in the exposed group with a hemorrhage
干预措施: The GAD-7 with a discrimination threshold ≥10. (Behavioral)
women in the exposed group with a hemorrhage
干预措施: • Spielberger's State-Trait anxiety inventory, Form Y (validated in French), with a STAI (form Y-A) discrimination threshold ≥ 46 (Behavioral)
women in the exposed group with a hemorrhage
干预措施: The IES-R, validated in French, with a discrimination threshold ≥ 30. (Behavioral)
Partners
干预措施: EPDS, MINI, STAI-A and B, IES-R and QEVA (experience) (Behavioral)
women in the nonexposed group without a hemorrhage
干预措施: • Spielberger's State-Trait anxiety inventory, Form Y (validated in French), with a STAI (form Y-A) discrimination threshold ≥ 46 (Behavioral)
women in the nonexposed group without a hemorrhage
干预措施: The IES-R, validated in French, with a discrimination threshold ≥ 30. (Behavioral)
women in the nonexposed group without a hemorrhage
干预措施: The GAD-7 with a discrimination threshold ≥10. (Behavioral)
women in the nonexposed group without a hemorrhage
干预措施: • The Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11. (Behavioral)
结局指标
主要结局
prevalence of depression
时间窗: at 12 months after delivery.
the prevalence of depression, measured by the Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11
次要结局
- prevalence of depression among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)(at 2 months, 6 months, and 12 months after delivery.)
- The prevalence of depression among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention(at 2 months, 6 months, and 12 months after delivery)
- severity of depression among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)(at 2 months, 6 months, and 12 months after delivery)
- severity of depression among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention(at 2 months, 6 months, and 12 months after delivery)
- prevalence of anxiety and post-traumatic stress among women after an immediate PPH(at 2 months, 6 months, and 12 months after delivery)
- prevalence of anxiety and post-traumatic stress among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)(at 2 months, 6 months, and 12 months after delivery)
- prevalence of anxiety and post-traumatic stress among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention(at 2 months, 6 months, and 12 months after delivery)
- severity of anxiety and post-traumatic stress among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)(at 2 months, 6 months, and 12 months after delivery)
- severity of anxiety and post-traumatic stress among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention(at 2 months, 6 months, and 12 months after delivery)
- prevalence of depression, post-traumatic stress, and anxiety, the experience of delivery, in partners of women with an immediate postpartum hemorrhage (< 24 hours)(at 2 months and 6 months after the woman gave birth.)