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Recruiting NCT04989894

Quality of Recovery After Childbirth

Observational Quality of Life Childbirth Maternal Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Quality of Life, Childbirth, Maternal Health. Basic parameters: 21 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating the Quality of Recovery After Childbirth

Overview

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.

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

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

Publications

  • 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

Identifiers

NCT: NCT04989894 · 2021/2160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗