Clinical trial NCT04989894: Quality of Recovery After Childbirth
Official title: Investigating the Quality of Recovery After Childbirth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Childbirth
Maternal Health
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-04
Enrollment: 122
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only parturients who have given birth will be recruited.

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.

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.

Primary outcomes:
measure: Change of ObsQoR-10-Chinese after 60 mins
timeFrame: Postpartum day 1; 1 day
measure: Change of ObsQoR-10-Malay after 60 mins
timeFrame: Postpartum day 1; 1 day
Secondary outcomes:
measure: Correlation between ObsQoR-10-Chinese and global health status
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10-Malay and global health status
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10-Chinese and recovery
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10-Malay and recovery
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10 and length of hospital stay
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10 and acute pain scores
timeFrame: Postpartum day 1; 1 day
measure: Correlation between ObsQoR-10 and breastfeeding self-efficacy
timeFrame: Postpartum day 7; 1 day
measure: Correlation between ObsQoR-10 and postnatal depressive symptoms
timeFrame: Postpartum day 7; 1 day
measure: Time on the use of ObsQoR-10
timeFrame: Postpartum day 1; 1 day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: Head and Senior Consultant, Women's Anaesthesia
name: Ban Leong Sng
role: PRINCIPAL_INVESTIGATOR
References: