PainNCT00777270
Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
A study testing repair of episiotomy or second degree tears in people with Pain, run by Hospital Universitario Principe de Asturias at 1 site in Spain.
Trial summary
The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain
- What is being tested?
- repair of episiotomy or second degree tears
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2005to Oct 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- vaginal childbirth
- at least 37 weeks of gestation
- assistance by one of the 4 matrons who participated in the project
- have been subjected to an episiotomy or the appearance of tearing that affected skin and muscle
- The newborn child had to be alive, viable
Who cannot join
- instrumentation
- produce injury in the anal sphincter or in the rectum.
- serious congenital malformations.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundación Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
About this study
The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches and less frequency of re stitching. The investigators research is looking for a technique for repairing the perineum more advantageously.
Read the detailed description
445 women who participated in the project had undergone normal deliveries with episiotomy or second-grade tearing of the perineum. One group was repaired with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. The other group used continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture. The threads used for stitching were identical in both groups. The same questions were asked concerning the sensation of pain and the use of painkillers, the second and the tenth day and at the three months.
- Conditions
- Pain
- Being tested
- repair of episiotomy or second degree tears
- Keywords
- episiotomy, perineal lesion, vaginal trauma
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of episiotomy or second degree tearsProcedure or surgery
Also called (Vicryl Rapid; Ethicon)
continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
repair of episiotomy or second degree tearsProcedure or surgery
Also called (Vicryl Rapid; Ethicon).
interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture
| Study group | Role | What they receive |
|---|---|---|
| 1 continuous | Experimental | continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. Receives: Procedure: repair of episiotomy or second degree tears |
| 2 interrupted | Experimental | interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture Receives: Procedure: repair of episiotomy or second degree tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at that moment ("pain now")
Measured: the second and the tenth day and at the three months.
Secondary outcomes (1)
If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued.
Measured: at the three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Principe de Asturias
- Sponsor type
- University, hospital or other
- Investigators
- Pedro Valenzuela, MD, Principal investigator, Hospital Prínicpe de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777270
- Sponsor's protocol ID
- FIS-PI051023
- Status last verified
- Oct 2008
- First submitted
- 21 Oct 2008
- Last updated
- 22 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R. Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial. Lancet. 2002 Jun 29;359(9325):2217-23. doi: 10.1016/S0140-6736(02)09312-1.
PubMed 12103284Fleming N. Can the suturing method make a difference in postpartum perineal pain? J Nurse Midwifery. 1990 Jan-Feb;35(1):19-25. doi: 10.1016/0091-2182(90)90053-8.
PubMed 2406391
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00777270
- Acronym / sponsor ID
- FIS-PI051023
- Conditions
- Pain
- Keywords
- episiotomy, perineal lesion, vaginal trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Hospital Universitario Principe de AsturiasUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Oct 2008 (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 best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches and less frequency of re stitching. The investigators research is looking for a technique for repairing the perineum more advantageously.
Detailed description
445 women who participated in the project had undergone normal deliveries with episiotomy or second-grade tearing of the perineum. One group was repaired with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. The other group used continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture. The threads used for stitching were identical in both groups. The same questions were asked concerning the sensation of pain and the use of painkillers, the second and the tenth day and at the three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 continuous | Experimental | Procedure: repair of episiotomy or second degree tearscontinuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. |
| 2 interrupted | Experimental | Procedure: repair of episiotomy or second degree tearsinterrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- vaginal childbirth
- at least 37 weeks of gestation
- assistance by one of the 4 matrons who participated in the project
- have been subjected to an episiotomy or the appearance of tearing that affected skin and muscle
- The newborn child had to be alive, viable
Key exclusion criteria (3 listed)
- instrumentation
- produce injury in the anal sphincter or in the rectum.
- serious congenital malformations.
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 |
|---|---|---|
| repair of episiotomy or second degree tearsAlso: (Vicryl Rapid; Ethicon)continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. | Procedure or surgery | 1 continuous |
| repair of episiotomy or second degree tearsAlso: (Vicryl Rapid; Ethicon).interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture | Procedure or surgery | 1 continuous, 2 interrupted |
Primary outcome
Pain at that moment ("pain now")
Time frame: the second and the tenth day and at the three months.
1 secondary outcome
If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued.
Time frame: at the three months.
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 22 Oct 2008.
- Results publication: PubMed 12103284Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R. Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial. Lancet. 2002 Jun 29;359(9325):2217-23. doi: 10.1016/S0140-6736(02)09312-1.
- Results publication: PubMed 2406391Fleming N. Can the suturing method make a difference in postpartum perineal pain? J Nurse Midwifery. 1990 Jan-Feb;35(1):19-25. doi: 10.1016/0091-2182(90)90053-8.
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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.
Pedro Valenzuela, MD principal investigator
Hospital Prínicpe de Asturias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repair of episiotomy or second degree tears in people with Pain, run by Hospital Universitario Principe de Asturias at 1 site in Spain.
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 22 Oct 2008. 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 Spain. 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 at that moment ("pain now") (time frame: the second and the tenth day and at the three months.). 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 NCT00777270, which also lists 2 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 22 Oct 2008.