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1.
2.
Trials ; 21(1): 945, 2020 Nov 23.
Article in English | MEDLINE | ID: mdl-33225972

ABSTRACT

BACKGROUND: Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour. METHODS/DESIGN: In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18-47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1-2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women's experiences, midwives' experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women's experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health. DISCUSSION: It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. TRIAL REGISTRATION {2A}: ClinicalTrials.gov NCT03770962 . Registered on 10 December 2018.


Subject(s)
Labor, Obstetric , Perineum , Adolescent , Adult , Delivery, Obstetric , Female , Humans , Infant, Newborn , Middle Aged , Multicenter Studies as Topic , Parturition , Pregnancy , Randomized Controlled Trials as Topic , Sweden , Young Adult
3.
Article in English | MEDLINE | ID: mdl-11451003

ABSTRACT

The aim of this study was to investigate the long-term results of abdominal urethropexy-colposuspension in terms of cure rate of stress urinary incontinence, complications and side effects. Between 1985 and 1992, 169 women between 27 and 79 years old underwent abdominal urethropexy-colposuspension at Stockholm Söder Hospital. In 1997 they were invited to participate in a long-term follow-up study, 5-11 years after the operation. One hundred and thirty-one women (78%) were willing to attend for a clinical review; 38 were lost to follow-up. At the follow-up visit all women were assessed with medical history, symptoms of incontinence, and their satisfaction and problems after the operation, following a predefined protocol. Peri- and postoperative data were retrieved from the files. The patients underwent a gynecological examination, measurement of residual urine volume and a provocative leakage test. One hundred and nine women (83%) were satisfied with the results of the operation and 22 (17%) were not. Seventy-one (54%) were subjectively completely dry, 48 (35%) had a little leakage and 14 (11%) had frequent leakage; 122 women were continent in the provocation test, and only 9 (7%) demonstrated leakage. The cure rate for stress incontinence was 93%. According to their medical histories 63 (48%) women had mixed incontinence before their operation. At the follow-up examination 43 of these 63 women still had symptoms of urgency. Twenty-six women with genuine stress incontinence before the operation had developed urgency or urge incontinence during the follow-up period. Urge symptoms before operation was a negative prognostic factor for a good outcome in terms of subjective cure of incontinence, but had no impact on objective cure rate or satisfaction of the operation. The cure rate for stress incontinence was high but still there were women who were not satisfied with the operation. Most of these complained of urge incontinence. There were few serious complications. The objective cure rate was better than the subjective cure rate.


Subject(s)
Urinary Incontinence, Stress/surgery , Adult , Aged , Female , Follow-Up Studies , Humans , Middle Aged , Time Factors , Treatment Outcome , Urethra/surgery , Uterus/surgery
4.
Int J Gynecol Cancer ; 9(4): 312-316, 1999 Jul.
Article in English | MEDLINE | ID: mdl-11240785

ABSTRACT

Among 2,895 malignant ovarian tumor cases referred to Radiumhemmet, Stockholm from 1975 through 1995, 36 were certified to be malignant mixed müllerian tumors. The overall prognosis was poor with only 18% five-year actuarial survival (median survival 16.6 months). Five patients are still surviving after 75, 68, 117, 121, and 168 months, respectively. Fifteen women treated with melphelan, doxorubicin (adriamycin) and cisplatin (MAP) had a five-year actuarial survival of 33.3% and a median survival of 19.8 months. In a multivariate analysis taking into account stage, age, radiation, type of chemotherapy, histopathologic type and completeness of surgery, the most important predictors for survival were stage (stages I-II vs stages III-IV, P < 0.05), histopathologic type (homologous vs heterologous, P < 0.05), and type of chemotherapy (MAP or CAP vs other types, P < 0.05). We concluded that homologous tumor and chemotherapy containing cisplatin, doxorubicin, and melphalan, as well as early stage of the tumor, provided the optimal survival rate.

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