Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia

Vaginal Delivery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786911
• Other study ID #: P2022/271,B406202200014
• Status: Completed
• Start date: October 27, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: CHU de Charleroi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Vaginal Delivery

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU de Charleroi	Charleroi	Hainaut

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Charleroi	Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PNNSGS2	nutrition score	day 1
Primary	ENA: analog digital scale	Analog pain scale: 0 no pain and 10 worst pain	day 1
Primary	ENA: analog digital scale	Analog pain scale: 0 no pain and 10 worst pain	day 3
Primary	ENA: analog digital scale	Analog pain scale: 0 no pain and 10 worst pain	day 7
Primary	FSS: Fatigue Severity Scale	fatigue score: 0 not tired and 10 very tired	day 1
Primary	FSS: Fatigue Severity Scale	fatigue score: 0 not tired and 10 very tired	day 3
Primary	FSS: Fatigue Severity Scale	fatigue score: 0 not tired and 10 very tired	day 7

External Links

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