Wound; Perineal Rupture, DehiscenceNCT03806348
Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery
A study testing Resuturing in people with Wound; Perineal Rupture, Dehiscence, run by Stockholm South General Hospital at 1 site in Sweden.
Trial summary
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or leave the rupture for secondary healing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound; Perineal Rupture, Dehiscence
- What is being tested?
- Resuturing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 12 Dec 2018to 1 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18 years old who had a vaginal delivery and suffered from a perineal rupture, grade 2 (spontaneous or episiotomy).
- No longer than two weeks has passed since delivery.
- The woman must be able to give informed consent.
Who cannot join
- Perineal rupture grade 3 and 4.
- Woman suffering from connective tissue disease.
- Ongoing treatment with oral cortisone or other immunosuppressive disease.
- Diabetes treated with insulin.
- Suspicion of occult damage of the anal sphincter.
- Earlier surgery of the perineum.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Stockholm South General Hospital
Stockholm, 11883
Anna Drca, MD, +46705618733, anna.lundmark-drca@sll.se
Denise Golmann, MD, +46707478144, denise.golmann@sll.se
About this study
Official title: Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or leave the rupture for secondary healing.
Read the detailed description
140 women will be included in the trial, 70 women will be randomized to resuturing and 70 women will be randomized to expectant management. The investigators will follow the women with clinical investigations after 2 and 4 weeks. After two weeks the healing will be measured using the REEDA scale and the women will be asked whether they breastfeed or not. The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression Scale).
After four weeks the above will be done again as well as collecting of the daily pain diary that the women have filled in since being included in the trial.
After one year the women will be seen again and the investigators will do a clinical investigation including ultrasound of the perineal body, measurement of the perineal body, POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI (Pelvic Floor Distress Inventory). These scales will help the investigators to find out if the women have moderate to much trouble with vaginal wideness and/ or moderate to much problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm, there will be indication for a perineal reconstruction.
The primary outcome will be to investigate whether early resuturing is reducing the need of a later secondary reconstruction of the perineal body compared with conservative management concerning dehisced perineal wounds.
The secondary outcomes will be to investigate whether early resuturing is reducing the risk of having symptoms from the perineum and/or sexual problems one year after delivery.
The healing of the wound and the estimated pain will be compared between the two groups.
Certain questions concerning secondary fear of childbirth will also be asked and compared between the two groups.
- Conditions
- Wound; Perineal Rupture, Dehiscence
- Being tested
- Resuturing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResuturingProcedure or surgery
Early reconstruction of the perineal body after wound dehiscence within two weeks of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Resuturing | Experimental | Early resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days. Receives: Procedure: Resuturing |
| Conservative treatment | No intervention | Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of late perineal reconstruction
Digital palpation of the perineal body and assessment of thickness. POP-Q score; nine points in the vagina are identified. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The measurements are taken when the Valsalva maneuver is performed by the woman.
Anovaginal distance using perineal ultrasound. Validated scales to identify specific symptoms from the perineum and to identify the feeling of vaginal wideness and the need for digital assistance during defecation.
PFDI 20- short form-version of pelvic floor distress inventory FSFI - female sexual function index PFIQ - pelvic floor impact questionnaire
Measured: One year
Secondary outcomes (11)
Pelvic floor symptoms and the impact on quality of life
The PFDI 20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. It includes 20 questions and 3 scales. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.
Measured: One year
Pelvic floor symptoms and the impact on quality of life
The PFIQ-7 is used to assess life impact in women with pelvic floor disorders. It consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
Measured: One year
Sexual function
The FSFI comprises of a 19 item questionnaire focused on sexual functioning. There are six domains assessed. The subject is advised to consider each of the questions in the context of the last 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter here is a threshold at 26.55 which means that all values below are classed as indicating female sexual dysfunction (FSD).
Measured: One year
Wound healing
REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation) scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.
Measured: 2 weeks
Wound healing
REEDA scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.
Measured: 4 weeks
Pain intensity measure: NRS
Self reported daily pain intensity. NRS ( numeric rating scale), each day is scored 0-10 ( 0= no pain, 10= pain as bad as can be).
Measured: From randomization to 4 weeks after.
Secondary fear of childbirth
One question concerning fear of giving birth in the future will be asked: "What kind of delivery method would you prefer if getting pregnant again in the future, vaginal delivery or planned c-section?". W-DEQ B (Wijma Delivery Expectancy Questionnaire) is a questionnaire measuring the fear of giving birth after delivering. The questionnaire consists of 33 questions, every question has a score from 1-6. The higher score, the higher is the fear of giving birth.
Measured: One year.
Affected breastfeeding
The participant will be asked whether she breastfeeds or not.
Measured: 2 weeks
Affected breastfeeding
The participant will be asked whether she breastfeeds or not.
Measured: 4 weeks
Psychological wellbeing
EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.
Measured: 4 weeks
Psychological wellbeing
EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start12 Dec 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound; Perineal Rupture, DehiscenceStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Ek, Stockholm South General Hospital
- Investigators
- Marion Ek, PhD, MD, Principal investigator, Department of Obstetrics and Gynecology, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806348
- Sponsor's protocol ID
- Paris2018
- Status last verified
- Jan 2019
- First submitted
- 29 Nov 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03806348
- Acronym / sponsor ID
- Paris2018
- Conditions
- Wound; Perineal Rupture, Dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 16 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.
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or leave the rupture for secondary healing.
Detailed description
140 women will be included in the trial, 70 women will be randomized to resuturing and 70 women will be randomized to expectant management. The investigators will follow the women with clinical investigations after 2 and 4 weeks. After two weeks the healing will be measured using the REEDA scale and the women will be asked whether they breastfeed or not. The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression Scale).
After four weeks the above will be done again as well as collecting of the daily pain diary that the women have filled in since being included in the trial.
After one year the women will be seen again and the investigators will do a clinical investigation including ultrasound of the perineal body, measurement of the perineal body, POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI (Pelvic Floor Distress Inventory). These scales will help the investigators to find out if the women have moderate to much trouble with vaginal wideness and/ or moderate to much problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm, there will be indication for a perineal reconstruction.
The primary outcome will be to investigate whether early resuturing is reducing the need of a later secondary reconstruction of the perineal body compared with conservative management concerning dehisced perineal wounds.
The secondary outcomes will be to investigate whether early resuturing is reducing the risk of having symptoms from the perineum and/or sexual problems one year after delivery.
The healing of the wound and the estimated pain will be compared between the two groups.
Certain questions concerning secondary fear of childbirth will also be asked and compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuturing | Experimental | Procedure: ResuturingEarly resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days. |
| Conservative treatment | No intervention | –Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman over 18 years old who had a vaginal delivery and suffered from a perineal rupture, grade 2 (spontaneous or episiotomy).
- No longer than two weeks has passed since delivery.
- The woman must be able to give informed consent.
Key exclusion criteria (6 listed)
- Perineal rupture grade 3 and 4.
- Woman suffering from connective tissue disease.
- Ongoing treatment with oral cortisone or other immunosuppressive disease.
- Diabetes treated with insulin.
- Suspicion of occult damage of the anal sphincter.
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 |
|---|---|---|
| ResuturingEarly reconstruction of the perineal body after wound dehiscence within two weeks of delivery. | Procedure or surgery | Resuturing |
Primary outcome
Need of late perineal reconstruction
Time frame: One year
Digital palpation of the perineal body and assessment of thickness. POP-Q score; nine points in the vagina are identified. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The measurements are taken when the Valsalva maneuver is performed by the woman. Anovaginal distance using perineal ultrasound. Validated scales to identify specific symptoms from the perineum and to identify the feeling of vaginal wideness and the need for digital assistance during defecation. PFDI 20- short form-version of pelvic floor distress inventory FSFI - female sexual function index PFIQ - pelvic floor impact questionnaire
11 secondary outcomes
Pelvic floor symptoms and the impact on quality of life
Time frame: One year
Pelvic floor symptoms and the impact on quality of life
Time frame: One year
Sexual function
Time frame: One year
Wound healing
Time frame: 2 weeks
Wound healing
Time frame: 4 weeks
Pain intensity measure: NRS
Time frame: From randomization to 4 weeks after.
Secondary fear of childbirth
Time frame: One year.
Affected breastfeeding
Time frame: 2 weeks
Affected breastfeeding
Time frame: 4 weeks
Psychological wellbeing
Time frame: 4 weeks
Psychological wellbeing
Time frame: One year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Wound; Perineal Rupture, Dehiscence
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
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.
Marion Ek, PhD, MD principal investigator
Department of Obstetrics and Gynecology, Stockholm South General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resuturing in people with Wound; Perineal Rupture, Dehiscence, run by Stockholm South General Hospital at 1 site in Sweden.
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 3 inclusion and 6 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 16 Jan 2019. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Drca, MD (+46705618733, anna.lundmark-drca@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need of late perineal reconstruction (time frame: One year). 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 16 Jan 2019.