NCT05786911

Brief Summary

The objective of this preliminary observational study is to evaluate, in the patient, a correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score on day 1, 3 and 7.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 5, 2023

Last Update Submit

March 15, 2023

Conditions

Vaginal Delivery

Outcome Measures

Primary Outcomes (7)

  • PNNSGS2

    nutrition score

    day 1

  • ENA: analog digital scale

    Analog pain scale: 0 no pain and 10 worst pain

    day 1

  • ENA: analog digital scale

    Analog pain scale: 0 no pain and 10 worst pain

    day 3

  • ENA: analog digital scale

    Analog pain scale: 0 no pain and 10 worst pain

    day 7

  • FSS: Fatigue Severity Scale

    fatigue score: 0 not tired and 10 very tired

    day 1

  • FSS: Fatigue Severity Scale

    fatigue score: 0 not tired and 10 very tired

    day 3

  • FSS: Fatigue Severity Scale

    fatigue score: 0 not tired and 10 very tired

    day 7

Study Arms (1)

vaginal delivery under epidural

60 patients, having had a vaginal delivery under an epidural, will be recruited at the maternity ward

Other: nutritional score

Interventions

nutritional scoreOTHER

correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score

vaginal delivery under epidural

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailseligibility is based on female gender: inclusion criteria vaginal delivery under epidural
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female population of age to carry a pregnancy to term, with an uncomplicated vaginal delivery under epidural analgesia

You may qualify if:

  • vaginal delivery under epidural

You may not qualify if:

  • patient's refusal
  • lack of communication in French
  • inability to give free and informed consent
  • surgery under anesthesia during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Charleroi

Charleroi, Hainaut, 6000, Belgium

Location

Related Publications (4)

  • Valko PO, Bassetti CL, Bloch KE, Held U, Baumann CR. Validation of the fatigue severity scale in a Swiss cohort. Sleep. 2008 Nov;31(11):1601-7. doi: 10.1093/sleep/31.11.1601.

    PMID: 19014080BACKGROUND

  • Chaltiel D, Adjibade M, Deschamps V, Touvier M, Hercberg S, Julia C, Kesse-Guyot E. Programme National Nutrition Sante - guidelines score 2 (PNNS-GS2): development and validation of a diet quality score reflecting the 2017 French dietary guidelines. Br J Nutr. 2021 Jan 14;125(1):118-120. doi: 10.1017/S0007114520004134. No abstract available.

    PMID: 33319724BACKGROUND

  • Tsoi KY, Chan RSM, Li LS, McAuliffe FM, Hanson MA, Tam WH, Ma RCW. Evaluation of dietary pattern in early pregnancy using the FIGO Nutrition Checklist compared to a food frequency questionnaire. Int J Gynaecol Obstet. 2020 Sep;151 Suppl 1(Suppl 1):37-44. doi: 10.1002/ijgo.13324.

    PMID: 32894588BACKGROUND

  • McAuliffe FM, Killeen SL, Jacob CM, Hanson MA, Hadar E, McIntyre HD, Kapur A, Kihara AB, Ma RC, Divakar H, Hod M. Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non-Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline. Int J Gynaecol Obstet. 2020 Sep;151 Suppl 1(Suppl 1):16-36. doi: 10.1002/ijgo.13334. No abstract available.

    PMID: 32894590BACKGROUND

Related Links

Study Officials

  • Philippe PD Dony, PhD

    CHU de Charleroi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Doctor Beugnies Maïté

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 28, 2023

Study Start

October 27, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

We do not yet know if the IPD sharing plan will be implemented

Locations

BE(1)