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Clinical Trials/NCT04989894
NCT04989894
Recruiting
Not Applicable

Investigating the Quality of Recovery After Childbirth

KK Women's and Children's Hospital1 site in 1 country122 target enrollmentDecember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
KK Women's and Children's Hospital
Enrollment
122
Locations
1
Primary Endpoint
Change of ObsQoR-10-Chinese after 60 mins
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2021
End Date
December 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
KK Women's and Children's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sng Ban Leong

Head of Department, Women's Anaesthesia

KK Women's and Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change of ObsQoR-10-Chinese after 60 mins

Time Frame: Postpartum day 1; 1 day

Repeat of ObsQoR-10-Chinese at 60 mins after the first postpartum day 1 ObsQoR-10-Chinese and its correlation to the previous hour ObsQoR-10-Chinese (test-retest reliability)

Change of ObsQoR-10-Malay after 60 mins

Time Frame: Postpartum day 1; 1 day

Repeat of ObsQoR-10-Malay at 60 mins after the first postpartum day 1 ObsQoR-10-Malay and its correlation to the previous hour ObsQoR-10-Malay (test-retest reliability)

Secondary Outcomes

  • Correlation between ObsQoR-10-Chinese and global health status(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10-Malay and global health status(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10-Chinese and recovery(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10 and acute pain scores(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10 and breastfeeding self-efficacy(Postpartum day 7; 1 day)
  • Time on the use of ObsQoR-10(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10-Malay and recovery(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10 and length of hospital stay(Postpartum day 1; 1 day)
  • Correlation between ObsQoR-10 and postnatal depressive symptoms(Postpartum day 7; 1 day)

Study Sites (1)

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