Vaginal TearingNCT02492152
Does the Use of Dianatal Reduce the Rate of Episiotomy and Vaginal Tears in Birth?
A study testing Study group in people with Vaginal Tearing, run by Meir Medical Center.
Trial summary
The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Tearing
- What is being tested?
- Study group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women on their first Childbirth
- Singleton pregnancy
- Over 37 weeks of pregnancy
- In active labor
- Women who intend to have a vaginally birth
- Women aged 18-45
Who cannot join
- Multiple pregnancy
- Births before 37 weeks
- History of tear degree III or more
- Women who intended to give birth by Caesarean section
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth
The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.
Read the detailed description
The risk for vaginal tears during birth is about 20%. These tears require surgical repair, are painful and make the recovery of the mother more difficult. Less commonly there is a risk of tear infection and regional scarring that make intercourse more difficult. Moreover, according to some studies, it appears that there is a link between damage to the pelvic floor and vagina during labor and Urinary incontinence in stress later in life.
It is clear that there is an advantage for the prevention of vaginal tears. Dianatal is a gel preparation, designed for use in births, in order to reduce the rate of vaginal tears and possibly shorten the second stage of labor.
Tested and found that using the gel reduces friction on tissue in processes simulating pressure of birth and therefore it is less likely to see tears in the vaginal tissue when using gel.
The product is approved for use by the ministry of health, was safety approved by regulatory bodies in Switzerland - the country of production.
So far, there is only one study published in the professional literature. The study found that using the gel at birth, reduces the duration of the second stage (full opening to the birth of the fetus) and reduces the rate of tears. The aim of the work was to investigate the effect of the product on the duration of labor. Women on their first birth, were divided randomly into two groups, one was treated with Dianatal from the stage of active labor, and the other group did not receive any treatment. In each research group were about ninety women. This is the single research in one population. In addition, the research group is too small to have statistical power in order to answer issues related to the number of vaginal tears and the need to perform episiotomies.
Considering such a significant issue for a woman who is giving birth and for the medical staff dealing with the newborn and in light of the minority research information on this subject, it is clear that there is room for further research.
Women who meet the inclusion criteria will be recruit to the research when arriving in the delivery room. They will sign the consent form and will be computerized randomized to one of two groups:
The study group - using DIANATAL according to manufacturer's protocol from their being in active labor.
The control group - women with the same conditions that will not be using this medicine that is checked.
The following data will be collected: medical background, pregnancy complications, preparations that were used to reduce the risk of birth tears before birth (perineal massage, EPINO), the duration of the stages in labor, use of epidural, neonatal weight, whether episiotomy or vaginal tears that required surgical intervention ( sewing) were done, post delivery process.
A comparison between the two groups will be made respectively with the results of the study that were defined.
- Conditions
- Vaginal Tearing
- Being tested
- Study group
- Keywords
- women, active labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupDevice
Dianatal
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Women who will not be using this medicine that is checked. |
| Study group | Experimental | Women who will use DIANATAL according to manufacturer's protocol from the stage of active labor. Receives: Device: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women who will go through episiotomy and vaginal tears during birth
Measured: A year and a half
Secondary outcomes (3)
Time of delivery
Measured: A year and a half
Number of women who will have post-delivery complications such as fever after childbirth, vaginal hematomas requiring intervention, long hospitalizations after birth.
Measured: A year and a half
Number of spontaneous vaginal births (that are not Instrumental deliveries)
Measured: A year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal TearingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biron tal, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492152
- Sponsor's protocol ID
- 0090-15
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eason E, Labrecque M, Wells G, Feldman P. Preventing perineal trauma during childbirth: a systematic review. Obstet Gynecol. 2000 Mar;95(3):464-71. doi: 10.1016/s0029-7844(99)00560-8.
PubMed 10711565Riener R, Leypold K, Brunschweiler A, Schaub A, Bleul U, Wolf P. Quantification of friction force reduction induced by obstetric gels. Med Biol Eng Comput. 2009 Jun;47(6):617-23. doi: 10.1007/s11517-009-0460-1. Epub 2009 Feb 24.
PubMed 19238473Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. J Perinat Med. 2008;36(2):129-35. doi: 10.1515/JPM.2008.024.
PubMed 18211256
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth
- ClinicalTrials.gov ID
- NCT02492152
- Acronym / sponsor ID
- 0090-15
- Conditions
- Vaginal Tearing
- Keywords
- women, active labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 8 Jul 2015 (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 purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.
Detailed description
The risk for vaginal tears during birth is about 20%. These tears require surgical repair, are painful and make the recovery of the mother more difficult. Less commonly there is a risk of tear infection and regional scarring that make intercourse more difficult. Moreover, according to some studies, it appears that there is a link between damage to the pelvic floor and vagina during labor and Urinary incontinence in stress later in life.
It is clear that there is an advantage for the prevention of vaginal tears. Dianatal is a gel preparation, designed for use in births, in order to reduce the rate of vaginal tears and possibly shorten the second stage of labor.
Tested and found that using the gel reduces friction on tissue in processes simulating pressure of birth and therefore it is less likely to see tears in the vaginal tissue when using gel.
The product is approved for use by the ministry of health, was safety approved by regulatory bodies in Switzerland - the country of production.
So far, there is only one study published in the professional literature. The study found that using the gel at birth, reduces the duration of the second stage (full opening to the birth of the fetus) and reduces the rate of tears. The aim of the work was to investigate the effect of the product on the duration of labor. Women on their first birth, were divided randomly into two groups, one was treated with Dianatal from the stage of active labor, and the other group did not receive any treatment. In each research group were about ninety women. This is the single research in one population. In addition, the research group is too small to have statistical power in order to answer issues related to the number of vaginal tears and the need to perform episiotomies.
Considering such a significant issue for a woman who is giving birth and for the medical staff dealing with the newborn and in light of the minority research information on this subject, it is clear that there is room for further research.
Women who meet the inclusion criteria will be recruit to the research when arriving in the delivery room. They will sign the consent form and will be computerized randomized to one of two groups:
The study group - using DIANATAL according to manufacturer's protocol from their being in active labor.
The control group - women with the same conditions that will not be using this medicine that is checked.
The following data will be collected: medical background, pregnancy complications, preparations that were used to reduce the risk of birth tears before birth (perineal massage, EPINO), the duration of the stages in labor, use of epidural, neonatal weight, whether episiotomy or vaginal tears that required surgical intervention ( sewing) were done, post delivery process.
A comparison between the two groups will be made respectively with the results of the study that were defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Women who will not be using this medicine that is checked. |
| Study group | Experimental | Device: Study groupWomen who will use DIANATAL according to manufacturer's protocol from the stage of active labor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women on their first Childbirth
- Singleton pregnancy
- Over 37 weeks of pregnancy
- In active labor
- Women who intend to have a vaginally birth
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Births before 37 weeks
- History of tear degree III or more
- Women who intended to give birth by Caesarean section
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 |
|---|---|---|
| Study groupDianatal | Device | Study group |
Primary outcome
number of women who will go through episiotomy and vaginal tears during birth
Time frame: A year and a half
3 secondary outcomes
Time of delivery
Time frame: A year and a half
Number of women who will have post-delivery complications such as fever after childbirth, vaginal hematomas requiring intervention, long hospitalizations after birth.
Time frame: A year and a half
Number of spontaneous vaginal births (that are not Instrumental deliveries)
Time frame: A year and a half
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Background: PubMed 10711565Eason E, Labrecque M, Wells G, Feldman P. Preventing perineal trauma during childbirth: a systematic review. Obstet Gynecol. 2000 Mar;95(3):464-71. doi: 10.1016/s0029-7844(99)00560-8.
- Background: PubMed 19238473Riener R, Leypold K, Brunschweiler A, Schaub A, Bleul U, Wolf P. Quantification of friction force reduction induced by obstetric gels. Med Biol Eng Comput. 2009 Jun;47(6):617-23. doi: 10.1007/s11517-009-0460-1. Epub 2009 Feb 24.
- Background: PubMed 18211256Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. J Perinat Med. 2008;36(2):129-35. doi: 10.1515/JPM.2008.024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Study group in people with Vaginal Tearing, run by Meir Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Biron, MD (972-9-747-2561, Tal.Biron-Shental@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women who will go through episiotomy and vaginal tears during birth (time frame: A year and a half). 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 NCT02492152, which also lists 3 linked publications.
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 8 Jul 2015.