Wound; Perineal Rupture, Dehiscence Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 140 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Obstetrics and Gynecology, Stockholm South General Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Stockholm South General Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
One year | |
| Secondary | 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. | One year | |
| Secondary | 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). | One year | |
| Secondary | 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). | One year | |
| Secondary | 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. | 2 weeks | |
| Secondary | 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. | 4 weeks | |
| Secondary | 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). | From randomization to 4 weeks after. | |
| Secondary | 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. | One year. | |
| Secondary | Affected breastfeeding | The participant will be asked whether she breastfeeds or not. | 2 weeks | |
| Secondary | Affected breastfeeding | The participant will be asked whether she breastfeeds or not. | 4 weeks | |
| Secondary | 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. | 4 weeks | |
| Secondary | 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. | One year. |