Quality of Recovery After Childbirth

Quality of Life Clinical Trial

Official title:

Investigating the Quality of Recovery After Childbirth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989894
• Other study ID #: 2021/2160
• Status: Recruiting
• Start date: December 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: KK Women's and Children's Hospital
• Contact: Ban Leong Sng
• Phone: +65 63941077
• Email: sng.ban.leong[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childbirth
• Maternal Health
• Quality of Life

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ObsQoR-10-Chinese after 60 mins	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)	Postpartum day 1; 1 day
Primary	Change of ObsQoR-10-Malay after 60 mins	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)	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10-Chinese and global health status	Correlation of postpartum day 1 ObsQoR-10-Chinese scores with EQ-5D-3L-Chinese scores and global health Visual analog scale (VAS) (GHVAS; how good or bad is patient's health today, in her opinion, from 100 'Best imaginable health state' to 0 'Worst imaginable health state')	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10-Malay and global health status	Correlation of postpartum day 1 ObsQoR-10-Malay scores with EQ-5D-3L-Malay scores and global health Visual analog scale (VAS) (GHVAS; how good or bad is patient's health today, in her opinion, from 100 'Best imaginable health state' to 0 'Worst imaginable health state')	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10-Chinese and recovery	Correlation of postpartum day 1 ObsQoR-10-Chinese scores with good recovery (postpartum 1 GHVAS >=70mm) vs poor recovery (postpartum day 1 GHVAS < 70mm)	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10-Malay and recovery	Correlation of postpartum day 1 ObsQoR-10-Malay scores with good recovery (postpartum 1 GHVAS >=70mm) vs poor recovery (postpartum day 1 GHVAS < 70mm)	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10 and length of hospital stay	Correlation of postpartum day 1 ObsQoR-10 scores with length of hospital stay (time from delivery to discharge)	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10 and acute pain scores	Correlation of postpartum day 1 ObsQoR-10 scores with acute pain scores (numerical rating scale 0 to 10; 0 being no pain and 10 being the pain worst imaginable)	Postpartum day 1; 1 day
Secondary	Correlation between ObsQoR-10 and breastfeeding self-efficacy	Correlation of postpartum day 1 ObsQoR-10 scores with breastfeeding self-efficacy measured by breastfeeding self-efficacy scale- short form (BSES-SF). Breastfeeding self-efficacy refers to a mother's confidence and perception of how well she can breastfeed her infant. The 14-item self-administered BSES-SF comes in a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. Scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.	Postpartum day 7; 1 day
Secondary	Correlation between ObsQoR-10 and postnatal depressive symptoms	Correlation of postpartum day 1 ObsQoR-10 scores with postnatal depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS). Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.	Postpartum day 7; 1 day
Secondary	Time on the use of ObsQoR-10	Time taken in minutes to complete the ObsQoR-10 questionnaire	Postpartum day 1; 1 day