NCT04989894

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Dec 2021Dec 2026

First Submitted

Initial submission to the registry

July 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

July 4, 2021

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Correlation between ObsQoR-10-Chinese and global health status

    Postpartum day 1; 1 day

  • Correlation between ObsQoR-10-Malay and global health status

    Postpartum day 1; 1 day

  • Correlation between ObsQoR-10-Chinese and recovery

    Postpartum day 1; 1 day

  • Correlation between ObsQoR-10-Malay and recovery

    Postpartum day 1; 1 day

  • Correlation between ObsQoR-10 and length of hospital stay

    Postpartum day 1; 1 day

  • +4 more secondary outcomes

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly parturients who have given birth will be recruited.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Only parturients who have given birth will be recruited.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Ban Leong Sng

    Head and Senior Consultant, Women's Anaesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department, Women's Anaesthesia

Study Record Dates

First Submitted

July 4, 2021

First Posted

August 4, 2021

Study Start

December 20, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations