Postpartum Perineal Pain Clinical Trial
Official title:
Descriptive Study About a Strategy of Micronutrient Management in Parturient and Layered Women With Proteochoc®, a Dietary Supplement Rich in Porphyra HSP®
| Verified date | July 2018 |
| Source | Pileje |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 25, 2017 |
| Est. primary completion date | April 25, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre hospitalier d'Auch | Auch |
| Lead Sponsor | Collaborator |
|---|---|
| Pileje |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |