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Идёт набор NCT04989894

Quality of Recovery After Childbirth

Наблюдательное Quality of Life Childbirth Maternal Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Quality of Life, Childbirth, Maternal Health. Базовые параметры: 21 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigating the Quality of Recovery After Childbirth

Обзор

In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

Подробное описание

Traditional postpartum outcome measures do not describe the patient experience or quality of recovery (QoR) after childbirth. A recent obstetric-specific recovery tool (ObsQoR-10) has been developed to assess the quality of recovery in patients in various mode of delivery on aspects of pain, drug side effects, comfort, control, ability to hold and feed the baby, independent mobilization and achievement of personal hygiene. However, this questionnaire is not yet validated in Asian population, especially in Chinese- and Malay-speaking patients.

The investigators aim to investigate the validity, reliability, feasibility, and responsiveness of the Chinese and Malay translated versions of ObsQoR-10. The investigators will first perform a pre-test in 5-10 patients for each language, of which an interview will be conducted to seek for their feedback and suggestions. Modification of questionnaire will be done if necessary, followed by recruitment of 112 patients at postpartum day 1 to fill in the Chinese/Malay translated ObsQoR-10 and other questionnaires related to their mood, anxiety and pain. In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

Первичные конечные точки

  • Change of ObsQoR-10-Chinese after 60 mins [Срок оценки: Postpartum day 1; 1 day]
  • Change of ObsQoR-10-Malay after 60 mins [Срок оценки: Postpartum day 1; 1 day]
Вторичные конечные точки (9)
  • Correlation between ObsQoR-10-Chinese and global health status [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10-Malay and global health status [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10-Chinese and recovery [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10-Malay and recovery [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10 and length of hospital stay [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10 and acute pain scores [Срок оценки: Postpartum day 1; 1 day]
  • Correlation between ObsQoR-10 and breastfeeding self-efficacy [Срок оценки: Postpartum day 7; 1 day]
  • Correlation between ObsQoR-10 and postnatal depressive symptoms [Срок оценки: Postpartum day 7; 1 day]
  • Time on the use of ObsQoR-10 [Срок оценки: Postpartum day 1; 1 day]

Критерии участия

Критерии включения

  • Aged 21-50 years old;
  • Able to read and understand written Chinese;
  • Primiparous and having singleton pregnancy;
  • Delivered via spontaneous vaginal delivery, or elective cesarean delivery;
  • ≥38 gestational week.

Критерии исключения

  • Failed neuraxial analgesia in those receiving elective cesarean delivery;
  • General anaesthesia;
  • Intrapartum cesarean delivery;
  • Women whose infants have died;
  • Mother or baby requiring ICU after delivery;
  • Assisted/ operative vaginal delivery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Сингапур · 1 центр
  • KK Women's and Children's Hospital — Singapore

Публикации

  • Tan HS, Tan CW, Sultana R, Yang L, Mok MUS, Sng BL. The correlation between quality of recovery and parturient outcomes after Cesarean delivery: a cohort study. Can J Anaesth. 2024 Sep;71(9):1272-1281. doi: 10.1007/s12630-024-02799-x. Epub 2024 Aug 12. PMID 39134784

Идентификаторы

NCT: NCT04989894 · 2021/2160

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗