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Completed

NCT Number: NCT05786911

Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia

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.

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Key information

Conditions

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Charleroi

Charleroi, Hainaut, 6000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutritional score

Other

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

Primary outcomes

  1. PNNSGS2

    Time frame: day 1

    nutrition score

  2. ENA: analog digital scale

    Time frame: day 1

    Analog pain scale: 0 no pain and 10 worst pain

  3. ENA: analog digital scale

    Time frame: day 3

    Analog pain scale: 0 no pain and 10 worst pain

  4. ENA: analog digital scale

    Time frame: day 7

    Analog pain scale: 0 no pain and 10 worst pain

  5. FSS: Fatigue Severity Scale

    Time frame: day 1

    fatigue score: 0 not tired and 10 very tired

  6. FSS: Fatigue Severity Scale

    Time frame: day 3

    fatigue score: 0 not tired and 10 very tired

  7. FSS: Fatigue Severity Scale

    Time frame: day 7

    fatigue score: 0 not tired and 10 very tired

Sponsors and collaborators

Lead sponsor

CHU de Charleroi

Other

Collaborators

  • Erasme University Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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