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

NCT02967796 | Completed

• 1 other identifier: PiL-Obs-ProtSC-014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Perineal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Doctor's evaluation

  Day 1 (day after the delivery)

• Doctor's evaluation

  Day 3

• Doctor's evaluation

  Day 56

• Patient's evaluation

  Day 1 (day after the delivery)

• Patient's evaluation

  Day 3

Study Arms (2)

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

Interventions

Proteochoc DIETARY_SUPPLEMENT

Supplemented group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women running their first pregnancy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

Centre hospitalier d'Auch

Auch, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: September 4, 2015
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

FR (1)