Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®

Descriptive Study About a Strategy of Micronutrient Management in Parturient and Layered Women With Proteochoc®, a Dietary Supplement Rich in Porphyra HSP®

The aim of the study is to evaluate in primiparous patients the benefit of supplementation with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture. The patient is followed from the delivery to 6 to 8 weeks after.

Study Overview

• Status: Completed
• Conditions: Postpartum Perineal Pain
• Intervention / Treatment: Dietary supplement: Proteochoc

Detailed Description

For this study, 60 patients are going to be included. There will be 2 groups : a supplemented one (proteochoc®) and a non supplemented one (control). The patients of these two groups will have the same follow-up At the time of inclusion, an inclusion card is completed describing the patient's socio-demographic characteristics, major medical, surgical and obstetric history. After an uncomplicated delivery, women stay in maternity for a maximum of 3 days. In accordance with standard medical practice, women will be seen daily from D0 to D + 3 by the nursing staff. The investigating physician and his team will complete the follow-up sheets in the aftermath (day1), day3 and 6-8 weeks after the usual visits.

The data collected are information on medication treatments, prescribed care, assessment of the patient's overall condition and recovery, and monitoring of perineal lesions and complications if applicable.

In the same time (day1, day3, day6, day14 and 6-8 weeks after, the patient will also complete a patient follow-up sheet to collect her impressions.

The data collected are the medications taken, the care taken, the general pain felt, the perineal pain felt if applicable, and the fatigue felt.

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

Contacts and Locations

Study Locations

• France
  • Auch, France
    • Centre Hospitalier d'Auch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women running their first pregnancy

Description

Inclusion Criteria:

• Female aged over 18
• First pregnancy
• Having given birth, at a term greater than or equal to 37 SA, by low route, of a single child born alive and not hospitalized in the aftermath of immediate layers
• For whom the investigator has freely decided to propose a complementation by Protéochoc® on the day of delivery and its sequences of layers
• Having freely decided to buy Protéochoc® and follow the advice of consumption proposed by its gynecologist-obstetrician
• Having agreed to sign a consent to participate in the investigation after receiving informed information from the investigator

Exclusion Criteria:

• Serious pathology running
• Suffering before the pregnancy of any of the following conditions:
• Chronic pelvic pain syndrome
• Ilio-inguinal, ilio-hypogastric and genito-femoral pudendal neuralgia
• Pains with osteo-ligamentary component: the syndrome of the dorsolumbar hinge and the coccygodynia
• Myofacial Syndrome
• Pain of muscular origin: the syndrome of the pyriform muscle, syndrome of the obturator muscle
• Pains of venous origin: pelvic varices
• Allergy to any of the components of Proteochoc®
• Patient refusing to participate or unable to participate in the survey due to major language problems or major neuropsychiatric disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Supplemented group; 6 capsule of Proteochoc during 4 day, from day 0 (day of delivery) to day 4	Dietary supplement: Proteochoc
Control group; no supplementation, just the same follow-up as supplemented group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perineal pain intensity in the sitting position	The primary outcome will be the perineal pain intensity in the sitting position measured by a visual analogue scale (rated 0 to 10) at day 6 in women who chose to complement versus women who did not wish to take the supplementation	day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doctor's evaluation	Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product	Day 1 (day after the delivery)
Doctor's evaluation	Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product	Day 3
Doctor's evaluation	Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product	Day 56
Patient's evaluation	Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product	Day 1 (day after the delivery)
Patient's evaluation	Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product	Day 3
Patient's evaluation	Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product	Day 6
Patient's evaluation	Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product	Day 14
Patient's evaluation	Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product	Day 56

Collaborators and Investigators

• Sponsor: PiLeJe

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2015
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): April 25, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PiL-Obs-ProtSC-014