Quality of Recovery After Childbirth

NCT ID: NCT04989894

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Quality of Life Childbirth Maternal Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sng Ban Leong

Head of Department, Women's Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ban Leong Sng

Role: PRINCIPAL_INVESTIGATOR

Head and Senior Consultant, Women's Anaesthesia

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Ban Leong Sng

Role: CONTACT

+65 63941077

Facility Contacts

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Ban Leong Sng

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39134784 (View on PubMed)

Other Identifiers

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2021/2160

Identifier Type: -

Identifier Source: org_study_id

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