Vaginal DeliveryNCT05786911
Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia
An observational study of Vaginal Delivery, run by CHU de Charleroi at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- nutritional score
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Oct 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Female population of age to carry a pregnancy to term, with an uncomplicated vaginal delivery under epidural analgesia
Who may be able to join
- vaginal delivery under epidural
Who cannot join
- patient's refusal
- lack of communication in French
- inability to give free and informed consent
- surgery under anesthesia during hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Vaginal Delivery
- Being tested
- nutritional score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional scoreOther
correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score
| Study group | Role | What they receive |
|---|---|---|
| vaginal delivery under epidural | 60 patients, having had a vaginal delivery under an epidural, will be recruited at the maternity ward Receives: Other: nutritional score |
What is being measured
The primary outcome is the main question the study is designed to answer.
PNNSGS2
nutrition score
Measured: day 1
ENA: analog digital scale
Analog pain scale: 0 no pain and 10 worst pain
Measured: day 1
ENA: analog digital scale
Analog pain scale: 0 no pain and 10 worst pain
Measured: day 3
ENA: analog digital scale
Analog pain scale: 0 no pain and 10 worst pain
Measured: day 7
FSS: Fatigue Severity Scale
fatigue score: 0 not tired and 10 very tired
Measured: day 1
FSS: Fatigue Severity Scale
fatigue score: 0 not tired and 10 very tired
Measured: day 3
FSS: Fatigue Severity Scale
fatigue score: 0 not tired and 10 very tired
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start27 Oct 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Charleroi
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital
- Responsible party
- Principal investigator, Maïté Beugnies, CHU de Charleroi
- Investigators
- Philippe PD Dony, PhD, Study director, CHU de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786911
- Sponsor's protocol ID
- P2022/271,B406202200014
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not yet know if the IPD sharing plan will be implemented
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.
PubMed 19014080Chaltiel 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.
PubMed 33319724Tsoi 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.
PubMed 32894588McAuliffe 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.
PubMed 32894590
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05786911
- Acronym / sponsor ID
- P2022/271,B406202200014
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CHU de CharleroiUniversity, hospital or other
- Collaborators
- Erasme University Hospital
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaginal delivery under epidural | – | Other: nutritional score60 patients, having had a vaginal delivery under an epidural, will be recruited at the maternity ward |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Female population of age to carry a pregnancy to term, with an uncomplicated vaginal delivery under epidural analgesia
Key inclusion criteria (1 listed)
- vaginal delivery under epidural
Key exclusion criteria (4 listed)
- patient's refusal
- lack of communication in French
- inability to give free and informed consent
- surgery under anesthesia during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional scorecorrelation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score | Other | vaginal delivery under epidural |
Primary outcome
PNNSGS2
Time frame: day 1
nutrition score
ENA: analog digital scale
Time frame: day 1
Analog pain scale: 0 no pain and 10 worst pain
ENA: analog digital scale
Time frame: day 3
Analog pain scale: 0 no pain and 10 worst pain
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 1
fatigue score: 0 not tired and 10 very tired
FSS: Fatigue Severity Scale
Time frame: day 3
fatigue score: 0 not tired and 10 very tired
FSS: Fatigue Severity Scale
Time frame: day 7
fatigue score: 0 not tired and 10 very tired
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 19014080Valko 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.
- Background: PubMed 33319724Chaltiel 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.
- Background: PubMed 32894588Tsoi 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.
- Background: PubMed 32894590McAuliffe 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.
- Factors associated with maternal postpartum fatigue: an observationalstudyLink provided by the sponsor.
- Overview of the postpartum period: Normal physiology and routine maternal careLink provided by the sponsor.
- Overview of the postpartum period: Disorders and complicationsLink provided by the sponsor.
- Nutrition in pregnancy: Assessment and counselingLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not yet know if the IPD sharing plan will be implemented
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe PD Dony, PhD study director
CHU de Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery, run by CHU de Charleroi at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PNNSGS2 (time frame: day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786911, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.