Objective
To investigate whether laparoscopic sacrohysteropexy (LSH) is non‐inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse.
Design
Multicentre ...randomised controlled, non‐blinded non‐inferiority trial.
Setting
Five non‐university teaching hospitals in the Netherlands, one university hospital in Belgium.
Population
126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery.
Methods
Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%.
Main outcome measures
Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP‐Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life.
Results
Laparoscopic sacrohysteropexy was non‐inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference −1.7%, 95% CI: −7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP.
Conclusion
Laparoscopic sacrohysteropexy was non‐inferior to SSHP for surgical failure of the apical compartment at 12 months’ follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent.
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Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.
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Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Objective
To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation.
Design
Multicentre, open‐label, randomised controlled ...trial.
Setting
Eighteen hospitals in the Netherlands and one hospital in England.
Population
Women with a symptomatic cyst or abscess of the Bartholin gland.
Methods
Women were randomised to treatment with Word catheter or marsupialisation.
Main outcome measures
The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10‐point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention‐to‐treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2).
Results
One hundred and sixty‐one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64–1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001).
Conclusions
In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates.
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Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.
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Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Introduction
The aim of this study was to compare patient satisfaction between remifentanil patient‐controlled analgesia (RPCA) and epidural analgesia (EA) for labor pain.
Material and methods
This ...prospective cohort study was carried out on primiparous women requesting analgesia for labor at a Teaching Hospital, Amsterdam, the Netherlands. Women self‐selected the analgesia of choice (RPCA n = 166 and EA n = 124) and were asked to complete the Woman's Views of Birth Labour Satisfaction Questionnaire (WOMBSLQ), within 24 h (T0), 3 months (T3) and 6 months (T6) after birth. The WOMBSLQ comprises 11 subscales, including pain during labor and general satisfaction. The main outcome measure was general satisfaction.
Results
There was no significant difference in the subscale of general satisfaction with labor and delivery (maximum of 14 points) between both groups at all three time points median score at T0 for RPCA was 12 vs. 13 for the EA group (p = 0.95); at T3: 12 vs. 12, respectively (p = 0.41); and at T6: 12 vs. 12, respectively (p = 0.69). Women in the EA group had significantly better pain relief (maximum of 21 points) at all three time points median score at T0 for RPCA was 14 vs. 18 for the EA group (p < 0.001); at T3: 13 vs. 17, respectively (p = 0.002); and at T6: 13 vs. 17, respectively (p = 0.003).
Conclusion
Both self‐selected groups did not differ in general satisfaction with labor and delivery at all three time points after birth despite a significantly higher experienced pain in the RPCA group.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Objective: The purpose of this study was to evaluate whether a less invasive treatment strategy results in a higher platelet count of the neonate and prevents intracranial hemorrhage in pregnant ...women who are at risk for fetal or neonatal alloimmune thrombocytopenia. Study Design: Between March 1989 and August 2000, 48 women with 56 pregnancies were treated. The population was divided into groups. A diagnostic fetal blood sample was taken in 7 cases that had a history of a sibling with an intracranial hemorrhage (group I; n = 8); treatment was provided, when necessary, with platelet transfusions and maternal administration of immunoglobulin. The other 48 cases, with a history of a sibling with severe thrombocytopenia but without intracranial hemorrhage, were retrospectively divided into group IIa (n = 16) and IIb (n = 32). In group IIa, at least 2 diagnostic fetal blood samples were taken, and when necessary, intrauterine platelet transfusion and immunoglobulin were administered (invasive treatment). In group IIb, no initial diagnostic fetal blood sampling was performed (noninvasive treatment). In 23 cases, immunoglobulin was administered, which was followed by predelivery fetal blood sampling in 8 cases. In 9 cases, only predelivery fetal blood sampling was performed, when necessary, followed by intrauterine platelet transfusion. Results: Results of our noninvasive treatment strategy were comparable to results of the invasive method in the prevention of intracranial hemorrhage (intracranial hemorrhage was not observed). In addition, there was an increasing trend in median platelet count and a lower number of cases with severe thrombocytopenia (<50 × 109/L) in the noninvasive compared with the invasive treatment group (median platelet count, 92 and 31 × 109/L, respectively). Conclusion: Our results indicate that a less invasive treatment strategy in patients who are at risk for fetal or neonatal alloimmune thrombocytopenia and who have no history of a previous child who was affected with intracranial hemorrhage seems justified. (Am J Obstet Gynecol 2001;185:683-8.)
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
SUMMARY
Maternal anti‐HPA‐1a antibodies can cause severe fetal and neonatal alloimmune thrombocytopenia (FNAIT), complicated by intracranial haemorrhage (ICH). Antenatal treatment with maternal ...intravenous immunoglobulin (IVIG) seems to protect against ICH even when thrombocytopenia persists. The aim of this study was to investigate if anti‐HPA‐1a antibodies and IVIG potentially affect vascular endothelial cells (ECs) in order to identify susceptibility for ICH. Human umbilical cord endothelial cells (HUVEC) were incubated with anti‐HPA‐1a antibodies with or without polyclonal IVIG and evaluated for EC activation. Maternal sera with anti‐HPA‐1a antibodies affected neither the EC expression of intracellular adhesion molecule‐1 (ICAM‐1), vascular adhesion molecule‐1 (VCAM‐1) and tissue factor (TF) nor the release of van Willebrand factor (vWF) or interleukin (IL)‐8 nor the integrity of ECs. Maternal sera obtained after IVIG treatment and polyclonal IVIG decrease constitutive and cytokine‐induced ICAM‐1 and VCAM‐1 expression on ECs. The results show that maternal anti‐HPA‐1a antibodies cause no activation or damage of ECs in this model. The clinical relevance of the de‐activating properties of IVIG on EC activation with respect to ICH deserves further investigation.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
To evaluate the long-term follow-up of surviving offspring after antenatal treatment for fetal or neonatal alloimmune thrombocytopenia (FNAIT).
Fifty children at risk of FNAIT were antenatally ...treated with maternal intravenous immunoglobulins (IVIG) (
n=11), IVIG with intrauterine platelet transfusions (IUPT) (
n=26) or IUPT alone (
n=9). In four cases (
n=4), only fetal blood sampling (FBS) was performed. One child died in the neonatal period and one was lost to follow up.
The remaining 48 children, aged 1.3–11.6 years (median 5.1 years), were given both general and neurological examinations and assessed on their development and susceptibility for infections or atopic constitution. In addition, immunoglobulin levels were measured in 17 infants, aged 5 years and older.
Intracranial hemorrhage (ICH) was not observed. The general health and neurodevelopmental outcome in the children was comparable to a normal Dutch population. Children not exposed to maternal IVIG treatment had significantly more infections and hearing problems than children exposed to IVIG treatment or the normal population. Immunoglobulin G, A and M levels were within the normal range, independent of treatment and severity of FNAIT. A high IgE level was more frequently seen in children exposed to IVIG, but did not result in clinical consequences such as allergy or atopy.
Antenatal treatment of children for FNAIT did not affect general health or neurodevelopmental outcome. In particular, exposure to IVIG in utero showed no adverse effect on the clinical outcome of these children.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
The purpose of this study was to evaluate whether maternally administered intravenous immunoglobulins (IVIG) and intrauterine platelet transfusions (IUPT) for fetal/neonatal alloimmune ...thrombocytopenia (FNAIT) affect the development of the fetal immune system.
The lymphocyte subset distribution of mononuclear cells of cord blood of 20 FNAIT newborns was analyzed by flow cytometry and compared with a control group of healthy newborns and a reference group treated with intrauterine erythrocyte transfusions (IUET) for hemolytic disease.
The percentage of monocytes, natural killer (NK) cells, ratios of mature and immature T cells and B cells, and resting or activated cells were not significantly different compared to the control group. In addition, the B-cell and T-cell populations showed a normal
in vitro antibody production and T-cell proliferation when compared with the control group.
Antenatal treatment for FNAIT with maternal IVIG with or without IUPT is not associated with lymphocyte activation or premature maturation of the neonatal immune system.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Plaque-like lesions and amyloid angiopathy were investigated in the frontal cerebral cortex of four patients with hereditary cerebral hemorrhage with amyloidosis (Dutch) (HCHWA-D), using ...immunohistochemical antibodies to beta amyloid protein (A beta), beta protein precursor (beta PP), synaptophysin, ubiquitin (UBQ), cathepsin D, paired helical filaments (PHF) and glial fibrillary acidic protein (GFAP), enzymehistochemical (acid phosphatase) and silver methenamine silver (MS) and Palmgren staining methods. Whereas A beta- and MS-positive diffuse plaques were found in all patients, only the three older patients showed neuritic or congophilic plaques, which were acid phosphatase and cathepsin D positive and contained beta PP-, synaptophysin- and UBQ-positive, but PHF-negative neurites. These plaques were surrounded by reactive astrocytes. Similar immuno- and enzymereactivity was found around congophilic blood vessels. Thus, apart from neuronal degeneration in a subset of plaque-like lesions and around blood vessels, this study shows an age-related morphology of the plaques in HCHWA-D, corresponding to that in Down's syndrome (DS), with the difference that neurofibrillary (NF) pathology is absent in HCHWA-D in contrast to DS. HCHWA-D may be considered as a model for congophilic plaque formation not associated with NF pathology.
Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation ...of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.
The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.
This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.
Dutch Trial Register: NTR3110.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its ...uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.
The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.
This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day.
Dutch Trial Register NTR2551, http://www.trialregister.nl.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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