NCT02967796

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®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: PiLeJe · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Perineal Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Proteochoc

Timeline

• Start date: 2015-09-04
• Primary completion: 2017-04-25
• Completion: 2017-04-25
• First posted: 2016-11-18
• Last updated: 2018-07-17

Locations

1 site across 1 country: France