Perineal LacerationsNCT00265421
Study of Different Suturing Techniques for Perineal Repair After Delivery
A study testing Suture technique for perineal repair after delivery in people with Perineal Lacerations and Episiotomy, run by University of Aarhus at 1 site in Denmark.
Trial summary
We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth. The participants are healthy primi para and deliver at term. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Lacerations, Episiotomy
- What is being tested?
- Suture technique for perineal repair after delivery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2004to Apr 2006
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.
Who cannot join
- Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Obstetrics and Gynaecology, Skejby Sygehus
Aarhus, 8200
About this study
Official title: The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.
The participants are healthy primi para and deliver at term.
Read the detailed description
A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas >36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy.
The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.
- Conditions
- Perineal Lacerations, Episiotomy
- Being tested
- Suture technique for perineal repair after delivery
- Keywords
- Suture Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture technique for perineal repair after deliveryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in perineal area day 1 and 10 after delivery.
Healing of wound day 1 and 10 after delivery.
Secondary outcomes (3)
Patient satisfaction with perineal sutures performed at birth.
Incontinence.
Need for resuturing of perineal area within 1 year after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startAug 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal LacerationsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Agency, Aase and Ejnar Danielsens Foundation, Aarhus University Hospital, The Danish Midwifery Organization, Sophus Jacobsen and wifes´ Foundation, Else and Mogens Wedell-Wedellsborgs´ Foundation, Frode V. Nyegaard and wifes´ Foundation, K. A. Rohde's and wife's Foundation
- Investigators
- Niels Uldbjerg, Professor, Study chair, Aarhus University Hopspital, dept. of Obst. & Gyn.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265421
- Sponsor's protocol ID
- The Danish Suture Trial
- Other IDs
- 2004-70 Etichs Committee
- Status last verified
- Sep 2009
- First submitted
- 13 Dec 2005
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
- ClinicalTrials.gov ID
- NCT00265421
- Acronym / sponsor ID
- The Danish Suture Trial
- Conditions
- Perineal Lacerations, Episiotomy
- Keywords
- Suture Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Research Agency, Aase and Ejnar Danielsens Foundation, Aarhus University Hospital, The Danish Midwifery Organization, Sophus Jacobsen and wifes´ Foundation, Else and Mogens Wedell-Wedellsborgs´ Foundation, Frode V. Nyegaard and wifes´ Foundation, K. A. Rohde's and wife's Foundation
- Study start
- Aug 2004
- Study completion
- Apr 2006
- First posted
- 14 Dec 2005 (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.
We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.
The participants are healthy primi para and deliver at term.
Detailed description
A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas >36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy.
The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.
Key exclusion criteria (1 listed)
- Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.
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 technique for perineal repair after delivery | Procedure or surgery | – |
Primary outcome
Pain in perineal area day 1 and 10 after delivery.
Healing of wound day 1 and 10 after delivery.
3 secondary outcomes
Patient satisfaction with perineal sutures performed at birth.
Incontinence.
Need for resuturing of perineal area within 1 year after delivery.
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 30 Sep 2009.
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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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.
Niels Uldbjerg, Professor study chair
Aarhus University Hopspital, dept. of Obst. & Gyn.
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 technique for perineal repair after delivery in people with Perineal Lacerations and Episiotomy, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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 30 Sep 2009. 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 Denmark. 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?
Pain in perineal area day 1 and 10 after delivery.. The study lists 2 primary outcomes in all. 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 30 Sep 2009.