Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Delivery
• Intervention / Treatment: Other: nutritional score

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Belgium
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • CHU de Charleroi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vaginal delivery under epidural; 60 patients, having had a vaginal delivery under an epidural, will be recruited at the maternity ward	Other: nutritional score; correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Charleroi
• Collaborators: Erasme University Hospital
• Investigators: Study Director: Philippe PD Dony, PhD, CHU de Charleroi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Factors associated with maternal postpartum fatigue: an observationalstudy
• Overview of the postpartum period: Normal physiology and routine maternal care
• Overview of the postpartum period: Disorders and complications
• Nutrition in pregnancy: Assessment and counseling

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: P2022/271,B406202200014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not yet know if the IPD sharing plan will be implemented

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No