Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Need of late perineal reconstruction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Perineal rupture grade 3 and
- •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.
研究组 & 干预措施
Resuturing
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.
干预措施: Resuturing (Procedure)
Conservative treatment
Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.
结局指标
主要结局
Need of late perineal reconstruction
时间窗: 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
次要结局
- Sexual function(One year)
- Pain intensity measure: NRS(From randomization to 4 weeks after.)
- Secondary fear of childbirth(One year.)
- Wound healing(4 weeks)
- Psychological wellbeing(One year.)
- Affected breastfeeding(4 weeks)
- Pelvic floor symptoms and the impact on quality of life(One year)
研究者
Marion Ek
Senior Consultant
Stockholm South General Hospital