Clinical trial NCT02967796: Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®
Official title: Descriptive Study About a Strategy of Micronutrient Management in Parturient and Layered Women With Proteochoc®, a Dietary Supplement Rich in Porphyra HSP®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Perineal Pain
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women running their first pregnancy

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: perineal pain intensity in the sitting position
timeFrame: day 6
Secondary outcomes:
measure: Doctor's evaluation
timeFrame: Day 1 (day after the delivery)
measure: Doctor's evaluation
timeFrame: Day 3
measure: Doctor's evaluation
timeFrame: Day 56
measure: Patient's evaluation
timeFrame: Day 1 (day after the delivery)
measure: Patient's evaluation
timeFrame: Day 3
measure: Patient's evaluation
timeFrame: Day 6
measure: Patient's evaluation
timeFrame: Day 14
measure: Patient's evaluation
timeFrame: Day 56
Other outcomes:
Locations:
city: Auch
country: France
facility: Centre hospitalier d'Auch
Study officials:
References: