Perineal TearNCT03670420
The Application of Honey on Perineal Sutures
A study testing Medical honey in people with Perineal Tear and Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery. 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
- Perineal Tear, Pain, Burns
- What is being tested?
- Medical honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2018to 1 Mar 2019
- 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
- Major women
- Giving birth vaginally in the maternity of Geneva university hospital
- First and second degree perineal tears or episiotomy
- French speaking women
- The day of the delivery
Who cannot join
- Allergic to honey and bees
- Drug use
- postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.
- Conditions
- Perineal Tear, Pain, Burns
- Being tested
- Medical honey
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical honeyOther
The investigators use Medihoney®, a medical honey released by the DermaSciences.
| Study group | Role | What they receive |
|---|---|---|
| Medical honey in addition to standard care | Experimental | In addition to the usual care provided by the maternity unit, women allocated to this group apply honey on first and second degree perineal tears, episiotomies and anterior vulvar tears twice a day for four days from randomization. Receives: Other: Medical honey |
| Standard care | No intervention | This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity.
Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 1
Saint Antoine questionnaire to measure perceived pain at day 1 post-partum
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High.
Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 1
Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity.
Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 4
Saint Antoine questionnaire to measure perceived pain at day 4 post-partum
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High.
Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 4
Secondary outcomes (4)
Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum
A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the "no burn" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity.
Burning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 1
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures.
Woman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times.
Measured: Day 1
Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum
A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the "no burn" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity.
Burning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Measured: Day 4
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures.
Woman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Sep 2018
- Primary completion31 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Julia GUITTIER, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670420
- Sponsor's protocol ID
- 2018-00995
- Other IDs
- 2018
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
https://doi.org/10.1007/s11724-008-0083-6
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03670420
- Acronym / sponsor ID
- 2018-00995
- Conditions
- Perineal Tear, Pain, Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical honey in addition to standard care | Experimental | Other: Medical honeyIn addition to the usual care provided by the maternity unit, women allocated to this group apply honey on first and second degree perineal tears, episiotomies and anterior vulvar tears twice a day for four days from randomization. |
| Standard care | No intervention | –This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major women
- Giving birth vaginally in the maternity of Geneva university hospital
- First and second degree perineal tears or episiotomy
- French speaking women
- The day of the delivery
Key exclusion criteria (3 listed)
- Allergic to honey and bees
- Drug use
- postpartum hemorrhage
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 |
|---|---|---|
| Medical honeyThe investigators use Medihoney®, a medical honey released by the DermaSciences. | Other | Medical honey in addition to standard care |
Primary outcome
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum
Time frame: Day 1
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Saint Antoine questionnaire to measure perceived pain at day 1 post-partum
Time frame: Day 1
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum
Time frame: Day 4
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Saint Antoine questionnaire to measure perceived pain at day 4 post-partum
Time frame: Day 4
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
4 secondary outcomes
Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum
Time frame: Day 1
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
Time frame: Day 1
Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum
Time frame: Day 4
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
Time frame: Day 4
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 12 Feb 2020.
- Backgroundhttps://doi.org/10.1007/s11724-008-0083-6
- The psychometric caractéristiques of the Saint Antoine QuestionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Perineal Tear
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruiting
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
Perineal Trauma
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
RecruitingObservational study
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Vaginal Laceration During Delivery
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 Medical honey in people with Perineal Tear and Pain, run by University Hospital, Geneva at 1 site in Switzerland.
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 5 inclusion and 3 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 12 Feb 2020. 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 Switzerland. 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?
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670420, which also lists 1 linked publication.
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 12 Feb 2020.