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Clinical Trials/NCT05786911
NCT05786911
Completed
Not Applicable

Evaluation of Postpartum Fatigue and Pain, After Childbirth Under Epidural Analgesia, According to the Nutritional Status of the Parturient: A Monocentric Observational Prospective Study

CHU de Charleroi1 site in 1 country60 target enrollmentOctober 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaginal Delivery
Sponsor
CHU de Charleroi
Enrollment
60
Locations
1
Primary Endpoint
PNNSGS2
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Several studies, focusing on nutrition during pregnancy, show that a healthy diet during pregnancy promotes fetal growth and development and has been associated with lower risks of complications, while unhealthy diets, undernutrition and overeating have been associated with adverse effects. Indeed, the FIGO initiative developed in 2015 a short nutritional questionnaire on adolescent nutrition, preconception and mothers. The FIGO Nutrition Checklist is an acceptable, potentially feasible, and validated clinical practice tool that can identify regular consumption of unhealthy diets or other nutrition and weight-related issues. Studies have shown that exhaustion, fatigue and pain are commonly experienced by the mother during the postpartum period and can impact daily functioning, mental health and parenting practices. Currently, the link between nutritional status, eating habits and postpartum pain and fatigue has not yet been clearly studied. Recognizing patients at risk of pain and fatigue, due to their nutritional status, could make it possible to adapt and anticipate their treatment, in particular analgesics, and to consider multidisciplinary management. The objective of this preliminary observational study is to evaluate, in the patient, a correlation between a score of eating habits and nutritional status of the parturient and a score of fatigue and postpartum pain at D 1, 3. and 7. After obtaining written consent, 60 patients, having given birth vaginally under an epidural, will be recruited at the maternity ward. The exclusion criteria will be the patient's refusal, the absence of communication in French, the impossibility of giving free and informed consent, surgery under anesthesia during hospitalization. Questionnaires adapted to assess the nutritional score and the PNNS-GS 2 eating habits of the patients will be completed by the doctor, at the maternity ward on D 1 postpartum. To do this, a typical 24-hour food day will be harvested and then extrapolated to a week. Age, lifestyle, sports habits, vitamin intake before and during pregnancy, weight before and during pregnancy, height, BMI, ASA status, history, duration of labour, complications during pregnancy, complications during childbirth, tears of the perineum, biology data and analgesic treatments will be collected in the medical file. A fatigue and pain score, FSS score and ENA score, respectively at rest and in motion, will be completed by the doctor on D1, D3 and D7 postpartum, either at the maternity ward or by telephone contact. The differences between the scores of days 1, 3 and 7 will be calculated.

Registry
clinicaltrials.gov
Start Date
October 27, 2022
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
CHU de Charleroi
Responsible Party
Principal Investigator
Principal Investigator

Maïté Beugnies

Principal Investigator Doctor Beugnies Maïté

CHU de Charleroi

Eligibility Criteria

Inclusion Criteria

  • vaginal delivery under epidural

Exclusion Criteria

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

Outcomes

Primary Outcomes

PNNSGS2

Time Frame: day 1

nutrition score

ENA: analog digital scale

Time Frame: day 7

Analog pain scale: 0 no pain and 10 worst pain

FSS: Fatigue Severity Scale

Time Frame: day 7

fatigue score: 0 not tired and 10 very tired

Study Sites (1)

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