Postpartum Perineal PainNCT02967796
Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®
An observational study of Postpartum Perineal Pain, run by PiLeJe at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Perineal Pain
- What is being tested?
- Proteochoc
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2015to 25 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women running their first pregnancy
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Proteochoc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteochocDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Supplemented group | 6 capsule of Proteochoc during 4 day, from day 0 (day of delivery) to day 4 Receives: Dietary Supplement: Proteochoc | |
| Control group | no supplementation, just the same follow-up as supplemented group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 6
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start4 Sep 2015
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Perineal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967796
- Sponsor's protocol ID
- PiL-Obs-ProtSC-014
- Status last verified
- Jul 2018
- First submitted
- 16 Nov 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study About a Strategy of Micronutrient Management in Parturient and Layered Women With Proteochoc®, a Dietary Supplement Rich in Porphyra HSP®
- ClinicalTrials.gov ID
- NCT02967796
- Acronym / sponsor ID
- PiL-Obs-ProtSC-014
- Conditions
- Postpartum Perineal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2015 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemented group | – | Dietary Supplement: Proteochoc6 capsule of Proteochoc during 4 day, from day 0 (day of delivery) to day 4 |
| Control group | – | –no supplementation, just the same follow-up as supplemented group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women running their first pregnancy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteochoc | Dietary supplement | Supplemented group |
Primary outcome
perineal pain intensity in the sitting position
Time frame: day 6
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
8 secondary outcomes
Doctor's evaluation
Time frame: Day 1 (day after the delivery)
Doctor's evaluation
Time frame: Day 3
Doctor's evaluation
Time frame: Day 56
Patient's evaluation
Time frame: Day 1 (day after the delivery)
Patient's evaluation
Time frame: Day 3
Patient's evaluation
Time frame: Day 6
Patient's evaluation
Time frame: Day 14
Patient's evaluation
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Perineal Pain, run by PiLeJe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perineal pain intensity in the sitting position (time frame: day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.