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临床试验/NCT07199803
NCT07199803招募中不适用

Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2025年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
152
试验地点
1
主要终点
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-48 hours

研究概览

简要总结

Postpartum hemorrhage (PPH) remains a leading cause of maternal death and morbidity. Moreover, it also contributes to psychological trauma such as depression and post-traumatic stress disorder. The American College of Obstetrics and Gynecology (ACOG) and the Society for Maternal Fetal Medicine (SMFM) defines this morbidity as an unintended outcome in the birthing process that may have significant short-term and long-term consequences to an individual's health. A recent study in 2018 developed core outcomes set for PPH through Delphi consensus encompassing elements of prevention and management of PPH.

Patient-reported outcomes, breastfeeding, and overall sense of wellbeing were not included in the final outcome set. Nevertheless, investigators felt strongly that they should be included, but further work was needed to assess the factors influencing the quality of recovery in the context of PPH. This is aligned with increasing recognition that patient experiences are important to improving the quality of care and quality of recovery after Cesarean delivery. The most effective, i.e. validated tool for assessing postpartum recovery is the Obstetric Quality of Recovery-10 (Obs-QoR-10). However its application in patients with PPH remains unexplored. It would appear logical that patient experiencing PPH experience a potentially more challenging recovery process which may include more surgical complications, depressive symptoms, sleep deprivation, physical exhaustion and stress due to unexpected and undesired delivery events. This study aims to compare Obs-QoR-10 scores in patients with and without PPH to evaluate the impact of severe postpartum bleeding on recovery outcomes using a matched case-control design.

The investigators plan to determine the differences in Obs-QoR-10 scores between patients who experience PPH during childbirth and those deliver without PPH, and to evaluate the impact of PPH on specific recovery domains (physical comfort, emotional well-being, and functional recovery).

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
是

入选标准

  • •Patients aged 18 years or older who have delivered at Mount Sinai Hospital.
  • •Delivery via vaginal or cesarean delivery with neuraxial analgesia or anesthesia
  • •Ability to communicate in English (to answer OBSQoR-10 survey) PPH Cohort
  • •Quantitative Blood Loss (QBL) ≥ 1000 mL or,
  • •Transfusion of blood due to PPH or,
  • •Transfer to ICU level care due to PPH
  • •Significant PPH intervention, i.e. hysterectomy or arterial embolization Non-PPH
  • •QBL < 500 mL and,
  • •No transfusion of blood products, and
  • •No need for elevated care environment, i.e. HAU or ICU

排除标准

  • •Patients with pre-existing psychiatric disorders affecting recovery assessment.
  • •Patients who experience severe obstetric complications other than PPH (e.g., eclampsia, uterine rupture).
  • •Overdistended uterus due to; Polyhydramnios (amniotic fluid index >24 cm) or multiple gestation
  • •History of previous PPH (documented with blood loss of >1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
  • •BMI > 50
  • •Language barrier (English)

结局指标

主要结局

Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-48 hours

时间窗: 24 hours

ObsQoR-10 score between 24 and 48 hours postpartum. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.

次要结局

  • Length of hospital stay (hours)(4 days)
  • Semi-quantitative blood loss total (ml)(1 hour)
  • Additional uterotonic medication administered - questionnaire(24 hours)
  • Blood transfusion(48 hours)
  • Surgical interventions for PPH - questionnaire(2 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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