Kirstine Sneider

Treatment of bacterial vaginosis in pregnancy in order to reduce the risk of spontaneous preterm delivery: a clinical recommendation

Bacterial vaginosis (BV) is characterized by a dysbiosis of the vaginal microbiota with a depletion of Lactobacillus spp. In pregnancy, prevalences between 7 and 30% have been reported depending on the study population and the definition. BV may be associated with an increased risk of spontaneous preterm delivery (sPTD). However, it is controversial whether or not BV‐positive pregnant women will benefit from treatment to reduce the risk of sPTD. We could not identify any good‐quality guideline addressing this issue. Consequently we aimed to produce this clinical recommendation based on GRADE.

Recurrence of second trimester miscarriage and extreme preterm delivery at 16–27 weeks of gestation with a focus on cervical insufficiency and prophylactic cerclage

The objective of this study was to describe recurrence rates of second trimester miscarriage and extreme preterm delivery by phenotype and use of prophylactic cerclage in a register‐based cohort.

Validation of second trimester miscarriages and spontaneous deliveries

Objective To validate the diagnosis of second trimester miscarriages/deliveries (16+0 weeks to 27+6 weeks of gestation) recorded as miscarriages in the Danish National Patient Registry or spontaneous deliveries in the Danish Medical Birth Registry, and asses the validity of risk factors, pregnancy complications, and cerclage by review of medical records. Materials and methods In a cohort of 2,358 women with a second trimester miscarriage/delivery in first pregnancy and a subsequent delivery during 1997–2012, we reviewed a representative sample of 682 medical records. We searched for clinically important information and calculated positive predictive values of the registry diagnoses stratified by type of registry, as well as sensitivity, specificity, positive predictive value, and kappa coefficients of risk factors, pregnancy complications, and cerclage. Results Miscarriage/spontaneous delivery in the second trimester was confirmed in 621/682 patients (91.1%). Pregnancy complications in second trimester miscarriages were underreported, resulting in low sensitivities and poor to moderate agreements between records and registries. There was a good agreement (kappa >0.6) between medical records and the registries regarding risk factors and cerclage. The diagnosis of cervical insufficiency had “moderate” kappa values for both miscarriages and deliveries (0.55 and 0.57). Conclusion Spontaneous second trimester deliveries and miscarriages recorded in the registers were confirmed by medical records in 91%, but register-based information on pregnancy complications need to be improved. We recommend that all pregnancies ending spontaneously beyond the first trimester are included in the national birth registry and described by appropriate variables.

Long-term follow-up after abdominal cerclage: A population-based cohort study.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Editor-in-Chief and the Authors as the Authors failed to request and receive permission to use the data from Aarhus Hospital.

Successful delivery after vaginal occlusion in addition to cerclage in a trachelectomy patient with recurrent second trimester pregnancy loss: a case report

Pregnancy outcome after trachelectomy has high risk of complications such as second trimester pregnancy loss and preterm birth. We report beneficial effect of a simple procedure of vaginal occlusion in addition to cerclage in a patient with trachelectomy and two prior second trimester pregnancy losses.

Withdrawal notice: Long-term follow-up after abdominal cerclage: A population-based cohort study

Withdrawal notice: long-term follow-up after abdominal cerclage: A population-based cohort study Kirstine Sneider *, Ole Bjarne Christiansen , Iben Blaabjerg Sundtoft , Jens Langhoff-Roos e a Department of Clinical Research, North Region Hospital, Hjørring, Denmark b Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark c The Fertility Clinic, University Hospital Copenhagen, Denmark d Department of Obstetrics and Gynecology, Aarhus University Hospital, Skejby, Aarhus, Denmark e Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

Validation of second trimester miscarriages and spontaneous deliveries [Corrigendum]

[This corrects the article on p. 517 in vol. 7, PMID: 26715859.].

Appreciable uncertainty regarding benefits and risks in the treatment of bacterial vaginosis to prevent preterm birth

Sir, As part of his speeches, the Roman senator Cato the Elder frequently uttered “Carthago delenda est” (Carthage must be destroyed). Similarly, Lamont and colleagues frequently utter that the “wrong patients with the wrong diagnosis were given wrong antibiotics at the wrong gestational age.” We respect that Lamont and colleagues find it difficult to accept meta-analyses, which “cut a toe and a bit of a heel” to merge evidence from more publications, and we certainly cannot exclude the possibility that future research will change clinical practice. However, in contrast to Lamont and colleagues, we emphasize that not only statistical significance but also other aspects should be taken into consideration in the development of clinical recommendations (1). Using GRADE, we found that appreciable uncertainty exists regarding the magnitude of benefits from clindamycin treatment compared with the risks. Given that the relative risk reported in Figure 5 represents the truth (2), the number needed to treat was 45 bacterial vaginosis (BV)-positive pregnant women to avoid one spontaneous preterm delivery (sPTD) before gestational week 37. This relatively minor effect should especially be measured against the microbiological concerns for iatrogenic damage when clindamycin is administered to approximately 10–15% of Danish pregnant women. These concerns include resistance development of BV-associated bacteria, Clostridium difficile colitis, and yet unknown adverse effects to the microbiome (3). The major concern raised by Lamont and colleagues seems to relate to whether the intervention with clindamycin before 22 weeks’ gestation would significantly reduce the incidence of sPTD (4). We agree that had the cut-off been gestational week 22, then the difference in incidence of sPTD would have been statistically significant with respect to clindamycin. Regardless, according to GRADE, the overall level of evidence for the outcome sPTD was rated low for reasons given in Supporting Information Table 2 (2). Regarding the PREMEVA 1 study, we agree that the risk of bias may have increased since October 2014 when we conducted the literature search. At this time, the PREMEVA1 abstract had only been published for 10 months (5). We sent out official emails to the authors; however, none responded. We agree that it is worrisome that the PREMEVA1 study is not yet published and we, as Lamont and colleagues, can only speculate why. Could publication bias due to negative findings be disregarded? Finally, it should be emphasized that we cannot confirm from our analyses that treatment of BV reduces the rate of early preterm birth and low birthweight infants, nor could we find the evidence in the review and meta-analysis by Lamont et al. from 2011 (6). In conclusion, we do not agree that the concerns mentioned by Lamont and colleagues would change the clinical recommendations in the recent AOGS publication (2). The weak recommendation against clindamycin reflects that some experts might treat BV in pregnancy whereas the majority would not, as “weak recommendations for or against intervention are made when guideline authors believe that most informed people would choose the recommended course of action, but a substantial number would not.”

Cerclage or cervical occlusion - What's the difference?

Sir, Cervical occlusion, introduced by Saling et al. in 1981, involves removal of the epithelium lining before circular stitching of the cervical canal followed by a double row of stitches, which close the outer os uteri completely. According to a newly published multicenter randomised controlled study any beneficial effect of a cervical occlusion is arbitrary. Brix et al. report that cervical occlusion in addition to cervical cerclage did not improve pregnancy outcome compared with cervical cerclage alone. It is important to note the description of the operative procedure as ‘a simpler, less traumatic technique whereby the external cervical os is occluded using a continuous suture at the time that the cerclage is applied’ (p.614). This simpler, less traumatic procedure is problematic because the mechanism of cervical occlusion is a complete closure of the cervical canal, so preventing ascension by microorganisms. A cerclage may improve the function of the cervical plug but probably does not prevent ascending infections because it only tightens but does not close the cervical canal. Misclassification of the procedures cerclage and cervical occlusion is apparently not a new phenomenon. Saling et al. emphasise at their homepage the difference between the techniques: ‘Not everything that is called “cervix occlusion” is actually a cervix occlusion according to Saling!’ The portio can only grow completely together if the superficial epithelium is removed before stitching. If this is not done, then it is not a cervix occlusion according to Saling, but in effect a kind of cerclage.’ So let us call a spade a spade: In the present study by Brix et al. ‘cervical closure’ was actually an extra cervical stitch at the external os; and not surprisingly the effect of this additional cervical stitch is similar to the effect of two stitches versus one stitch for transvaginal cerclage—no effect. Whereas we question the surgical procedure used in the study, we do agree with Brix et al.’s final recommendation, namely that another large randomised controlled trial is needed to test the effect of cervical occlusion.&