Quality of LifeNCT04989894
Quality of Recovery After Childbirth
An observational study of Quality of Life and Childbirth, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Quality of Life, Childbirth, Maternal Health
- How many people
- 122 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Only parturients who have given birth will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Ban Leong Sng
About this study
Official title: Investigating the Quality of Recovery After Childbirth
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.
Read the 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.
- Conditions
- Quality of Life, Childbirth, Maternal Health
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Postpartum day 1; 1 day
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)
Measured: Postpartum day 1; 1 day
Secondary outcomes (9)
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')
Measured: Postpartum day 1; 1 day
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')
Measured: Postpartum day 1; 1 day
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)
Measured: Postpartum day 1; 1 day
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)
Measured: Postpartum day 1; 1 day
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)
Measured: Postpartum day 1; 1 day
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)
Measured: Postpartum day 1; 1 day
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.
Measured: Postpartum day 7; 1 day
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.
Measured: Postpartum day 7; 1 day
Time on the use of ObsQoR-10
Time taken in minutes to complete the ObsQoR-10 questionnaire
Measured: Postpartum day 1; 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start20 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, Principal investigator, Head and Senior Consultant, Women's Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989894
- Sponsor's protocol ID
- 2021/2160
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39134784
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Quality of Recovery After Childbirth
- ClinicalTrials.gov ID
- NCT04989894
- Acronym / sponsor ID
- 2021/2160
- Conditions
- Quality of Life, Childbirth, Maternal Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Only parturients who have given birth will be recruited.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 39134784Tan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ban Leong Sng principal investigator
Head and Senior Consultant, Women's Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Childbirth, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ban Leong Sng (+65 63941077, sng.ban.leong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ObsQoR-10-Chinese after 60 mins (time frame: Postpartum day 1; 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.