Perineal TearNCT03825211
Continuous Versus Discontinuous Suture in the Perineals Lesions
A study testing Continuous suture in the perineals lesions and Discontinuous suture in the perineals lesions in people with Perineal Tear and Episiotomy Wound, run by University of Jaén.
Trial summary
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. 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, Episiotomy Wound
- What is being tested?
- Continuous suture in the perineals lesions and Discontinuous suture in the perineals lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 Dec 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
- Age >18 years
- Primiparous
- Singleton and eutocic delivery
- Second-degree perineal tear or an episiotomy as part of labor
- Newborn weight between 2500 g and 4000 g
Who cannot join
- Language barrier (to no speak spanish)
- Problems related to the pelvic floor prior to labor (prolapse, incontinence, vulva varices)
- Dyspareunia or sexual dysfunction
- Hemorrhoids perceived as uncomfortable or painful
About this study
Official title: Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were followed-up as follows: Day of childbirth and in the postpartum period.
Read the detailed description
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were allocated to a treatment group using a computer-generated random numbers table. The sequence was placed in individual opaque envelopes that were opened when a woman met the inclusion criteria.
The health personnel that carry out the sutures had taken a training course on continuous suture technique and had at least one year experience in this technique. Additionally, this person had a minimum of five years of experience in attending deliveries and therefore also in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around 5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and 20% of the midwives in Ubeda and Linares participated.
Data collection Data was collected on sociodemographic variables, type of perineal trauma (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number of suture packets used, complications, analogical scale of pain, type of pain, need for analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of sexual relations, start of physical activity and type of newborn feeding. It was also collected the start and type of delivery, medication during dilation, type of analgesia used, gestational week, duration of dilation, second stage labor and delivery, and data on the newborn.
Information was gathered by midwives which interviewed the women in the labor room, providing them with an informed consent form, and hiding the suture technique that was going to be used. The rest of the data were obtained from the clinical history, maternal record book and phone calls made for the follow-up. The women did not know at any point which suture technique had been used.
Follow-up
The women were followed-up as follows:
Day of childbirth: in the postpartum period, the midwife collected data on the type of delivery, need for epidural analgesia, duration of dilation, stage two of labor, delivery, type of perineal trauma, time used to place suture, number of suture packets, wound complications, newborn weight and the Apgar score at one minute and at five minutes. After the suture was placed, they assessed pain on the pain scale and assessed the wound.
Follow-up after delivery was done at two hours, 24 hours, 15 days and three months. Pain, need for analgesia, wound condition, sphincter incontinence and the start of sexual relations were assessed (15 days and three months).
- Conditions
- Perineal Tear, Episiotomy Wound
- Being tested
- Continuous suture in the perineals lesions, Discontinuous suture in the perineals lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous suture in the perineals lesionsProcedure or surgery
A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.
Discontinuous suture in the perineals lesionsProcedure or surgery
Suture the muscle independently of the vagina and independently of the skin
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture | Experimental | All parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion Receives: Procedure: Continuous suture in the perineals lesions |
| Discontinuous suture | Active comparator | Interrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion Receives: Procedure: Discontinuous suture in the perineals lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analogical scale of pain
It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity
Measured: After delivery was done at two hours
Numerical verbal scale for pain
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
Measured: After delivery was done at 24 hours
Numerical verbal scale for pain
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
Measured: After delivery was done at 15 days
Numerical verbal scale for pain
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
Measured: After delivery was done at three months.
Secondary outcomes (3)
Questionnaire
The woman was asked if she had involuntary urine losses.The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)
Measured: After delivery was done 15 days
Questionnaire
The woman was asked if she had involuntary urine losses. The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)
Measured: After delivery was done three months.
Questionnaire on Women Sexual Function (WSF)
This questionnaire has been validated in Spain. The instrument is composed of two types of domains: the evaluators of sexual activity, which are answered by a Likert scale of five values; and the descriptive ones, which have no quantitative value and help to know issues such as the frequency of sexual activity or the existence of sexual dysfunction in the respondent. It consists of 14 items, an alternative item and a question to open the questionnaire. To diagnose sexual dysfunction, only 6 questions are counted: Desire, Excitement, Lubrication, Orgasm, Problems with vaginal penetration, Anticipatory anxiety. Diagnostic results are categorized into: severe, moderate and no-disorder disorder. It does not establish degrees of dysfunctionality of sexual function, it is not shown in validation study if there is a cutoff point. The maximum score of this questionnaire is 100, which is interpreted as "without sexual dysfunction".
Measured: After delivery was done at three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Nov 2016
- Primary completion31 May 2018
- Study completion31 Dec 2018
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 Perineal TearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Miguel Martinez-Galiano, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825211
- Sponsor's protocol ID
- Ujaen Sutura Lesiones
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez-Galiano JM, Arredondo-Lopez B, Hidalgo-Ruiz M, Narvaez-Traverso A, Lopez-Moron I, Delgado-Rodriguez M. Suture type used for perineal injury repair and sexual function: a randomised controlled trial. Sci Rep. 2020 Jun 29;10(1):10553. doi: 10.1038/s41598-020-67659-2.
PubMed 32601329Martinez-Galiano JM, Arredondo-Lopez B, Molina-Garcia L, Camara-Jurado AM, Cocera-Ruiz E, Rodriguez-Delgado M. Continuous versus discontinuous suture in perineal injuries produced during delivery in primiparous women: a randomized controlled trial. BMC Pregnancy Childbirth. 2019 Dec 16;19(1):499. doi: 10.1186/s12884-019-2655-2.
PubMed 31842788
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03825211
- Acronym / sponsor ID
- Ujaen Sutura Lesiones
- Conditions
- Perineal Tear, Episiotomy Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Jan 2019 (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.
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were followed-up as follows: Day of childbirth and in the postpartum period.
Detailed description
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were allocated to a treatment group using a computer-generated random numbers table. The sequence was placed in individual opaque envelopes that were opened when a woman met the inclusion criteria.
The health personnel that carry out the sutures had taken a training course on continuous suture technique and had at least one year experience in this technique. Additionally, this person had a minimum of five years of experience in attending deliveries and therefore also in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around 5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and 20% of the midwives in Ubeda and Linares participated.
Data collection Data was collected on sociodemographic variables, type of perineal trauma (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number of suture packets used, complications, analogical scale of pain, type of pain, need for analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of sexual relations, start of physical activity and type of newborn feeding. It was also collected the start and type of delivery, medication during dilation, type of analgesia used, gestational week, duration of dilation, second stage labor and delivery, and data on the newborn.
Information was gathered by midwives which interviewed the women in the labor room, providing them with an informed consent form, and hiding the suture technique that was going to be used. The rest of the data were obtained from the clinical history, maternal record book and phone calls made for the follow-up. The women did not know at any point which suture technique had been used.
Follow-up
The women were followed-up as follows:
Day of childbirth: in the postpartum period, the midwife collected data on the type of delivery, need for epidural analgesia, duration of dilation, stage two of labor, delivery, type of perineal trauma, time used to place suture, number of suture packets, wound complications, newborn weight and the Apgar score at one minute and at five minutes. After the suture was placed, they assessed pain on the pain scale and assessed the wound.
Follow-up after delivery was done at two hours, 24 hours, 15 days and three months. Pain, need for analgesia, wound condition, sphincter incontinence and the start of sexual relations were assessed (15 days and three months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture | Experimental | Procedure: Continuous suture in the perineals lesionsAll parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion |
| Discontinuous suture | Active comparator | Procedure: Discontinuous suture in the perineals lesionsInterrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Primiparous
- Singleton and eutocic delivery
- Second-degree perineal tear or an episiotomy as part of labor
- Newborn weight between 2500 g and 4000 g
Key exclusion criteria (4 listed)
- Language barrier (to no speak spanish)
- Problems related to the pelvic floor prior to labor (prolapse, incontinence, vulva varices)
- Dyspareunia or sexual dysfunction
- Hemorrhoids perceived as uncomfortable or painful
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 |
|---|---|---|
| Continuous suture in the perineals lesionsA continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread. | Procedure or surgery | Continuous suture |
| Discontinuous suture in the perineals lesionsSuture the muscle independently of the vagina and independently of the skin | Procedure or surgery | Discontinuous suture |
Primary outcome
Analogical scale of pain
Time frame: After delivery was done at two hours
It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity
Numerical verbal scale for pain
Time frame: After delivery was done at 24 hours
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
Numerical verbal scale for pain
Time frame: After delivery was done at 15 days
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
Numerical verbal scale for pain
Time frame: After delivery was done at three months.
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
3 secondary outcomes
Questionnaire
Time frame: After delivery was done 15 days
Questionnaire
Time frame: After delivery was done three months.
Questionnaire on Women Sexual Function (WSF)
Time frame: After delivery was done at 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 31 Jan 2019.
- Derived from this study: PubMed 32601329Martinez-Galiano JM, Arredondo-Lopez B, Hidalgo-Ruiz M, Narvaez-Traverso A, Lopez-Moron I, Delgado-Rodriguez M. Suture type used for perineal injury repair and sexual function: a randomised controlled trial. Sci Rep. 2020 Jun 29;10(1):10553. doi: 10.1038/s41598-020-67659-2.
- Derived from this study: PubMed 31842788Martinez-Galiano JM, Arredondo-Lopez B, Molina-Garcia L, Camara-Jurado AM, Cocera-Ruiz E, Rodriguez-Delgado M. Continuous versus discontinuous suture in perineal injuries produced during delivery in primiparous women: a randomized controlled trial. BMC Pregnancy Childbirth. 2019 Dec 16;19(1):499. doi: 10.1186/s12884-019-2655-2.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suture in the perineals lesions and Discontinuous suture in the perineals lesions in people with Perineal Tear and Episiotomy Wound, run by University of Jaén.
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 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: finished, as of the sponsor's last update on 31 Jan 2019. 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?
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?
Analogical scale of pain (time frame: After delivery was done at two hours). 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 NCT03825211, 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 31 Jan 2019.