ParturitionImSOLENCENCT02870712
Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth
A study testing Suture of perineum and hemostatis by digital compression in people with Parturition and Delivery, Obstetric, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition, Delivery, Obstetric
- What is being tested?
- Suture of perineum and hemostatis by digital compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2017to 4 Sep 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- single Pregnancy
- primiparae
- delivery by spontaneous vaginal delivery
- forward Delivery (≥ 37 weeks)
- cephalic presentation
- children living
- perineal tear or isolated first-degree vaginal tear
Who cannot join
- Known haemostatic anomaly
- Premature birth (before 37)
- caesarean
- Instrumental delivery
- Placenta and / or uterine revision
- episiotomy
- perineal tear ≥ 2nd degree
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.
Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.
Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.
- Conditions
- Parturition, Delivery, Obstetric
- Being tested
- Suture of perineum, hemostatis by digital compression
- Keywords
- perineal tear of first degree, suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture of perineumProcedure or surgery
suture of the tear to obtain hemostasis
hemostatis by digital compressionProcedure or surgery
Digital compression of the tear to obtain hemostasis
| Study group | Role | What they receive |
|---|---|---|
| suture directed | Experimental | The suture of the perineum is headed by obtaining hemostasis by digital compression 5 minutes; If hemostasis is obtained, the perineum will not be sutured. In case of failure of hemostasis, suture of the perineum will be realized. Receives: Procedure: Suture of perineum; Procedure: hemostatis by digital compression |
| systematic suture | Active comparator | systematic suture tears following current recommendations Receives: Procedure: Suture of perineum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum
Measured: ten day after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start21 Mar 2017
- Primary completion13 Jul 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870712
- Sponsor's protocol ID
- P/2016/296
- Acronym
- ImSOLENCE
- Status last verified
- Sep 2018
- First submitted
- 21 Jul 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study
- ClinicalTrials.gov ID
- NCT02870712
- Acronym / sponsor ID
- ImSOLENCE / P/2016/296
- Conditions
- Parturition, Delivery, Obstetric
- Keywords
- perineal tear of first degree, suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 17 Aug 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.
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.
Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.
Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suture directed | Experimental | Procedure: Suture of perineum, Procedure: hemostatis by digital compressionThe suture of the perineum is headed by obtaining hemostasis by digital compression 5 minutes; If hemostasis is obtained, the perineum will not be sutured. In case of failure of hemostasis, suture of the perineum will be realized. |
| systematic suture | Active comparator | Procedure: Suture of perineumsystematic suture tears following current recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- single Pregnancy
- primiparae
- delivery by spontaneous vaginal delivery
- forward Delivery (≥ 37 weeks)
- cephalic presentation
Key exclusion criteria (7 listed)
- Known haemostatic anomaly
- Premature birth (before 37)
- caesarean
- Instrumental delivery
- Placenta and / or uterine revision
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 |
|---|---|---|
| Suture of perineumsuture of the tear to obtain hemostasis | Procedure or surgery | suture directed, systematic suture |
| hemostatis by digital compressionDigital compression of the tear to obtain hemostasis | Procedure or surgery | suture directed |
Primary outcome
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum
Time frame: ten day after childbirth
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 3 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Suture of perineum and hemostatis by digital compression in people with Parturition and Delivery, Obstetric, run by Centre Hospitalier Universitaire de Besancon 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 7 inclusion and 7 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 3 Aug 2021. 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?
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum (time frame: ten day after childbirth). 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 3 Aug 2021.