Obstetrics and Gynaecology

Management of mid-urethral tape complications: a retrospective study (2020)

Posted on by

Type of publication:
Journal article

Author(s):
Offiah I.; *Rachaneni S.; Dua A.

Citation:
Journal of Obstetrics and Gynecology of India; Apr 2020; vol. 70 (no. 2); p. 152-157

Abstract:
Background/purpose of the study: Following mid-urethral tape insertion, for stress urinary incontinence (SUI), a proportion of women experience complications such as voiding dysfunction or tape erosion which fail to respond to conservative management approaches. These women thus require further surgical treatment. Our objective was to describe the outcomes of the surgical management of complications in these women. Method(s): This retrospective study describes the results obtained following the surgical management of mid-urethral tape complications. Twenty-nine consecutive women who required mid-urethral tape lysis, loosening or excision for tape-related complications in the period 2007-2017 were included. Primary outcomes were improvement in voiding dysfunction and resolution of pain, while secondary outcomes were evaluation of the recurrence of stress urinary incontinence and patient satisfaction. Patient outcomes were measured using the Patient Global Impression of Improvement questionnaire. Result(s): There were 1459 mid-urethral tape procedures performed in the study period. Twenty-nine women (1.99%) who had revision surgery for tape complication were identified. Interventions included tape loosening or lysis in 19 women and tape excision in ten women. Twenty-three of the 29 patients reported a significant improvement in their symptoms postoperatively. Two women had a recurrence of SUI in the tape excision cohort; all patients following tape loosening or lysis remained continent. Conclusion(s): Tape revision surgery is a safe and effective treatment for mid-urethral tape complications with the majority of women maintaining continence following revision. Early intervention and proactive management of complications, by the appropriate specialist, will improve outcomes.

Link to full-text [no password required]

Altmetrics:

Expansile Endocervical Crypt Involvement by CIN2-3 as a Risk Factor for High Grade Cytology Recurrence after Cold Coagulation Cervical Treatment (2020)

Posted on by

Type of publication:
Journal article

Author(s):
*Papoutsis D.; *Underwood M.; *Parry-Smith W.; *Panikkar J.; *Williams J.

Citation:
Geburtshilfe und Frauenheilkunde; Sep 2020; vol. 80 (no. 9); p. 891-895

Abstract:
Introduction: To determine whether expansile endocervical crypt involvement (ECI) on pretreatment cervical punch biopsies is a risk factor for high grade cytology recurrence in women following cold coagulation for cervical intraepithelial neoplasia (CIN).Materials and Methods: This was a secondary analysis on the results of an observational study of women who had a single cold coagulation cervical treatment between 2001–2011 and who were followed up for cytology recurrence. Women with a previous cervical treatment were excluded.
Results: 559 women were identified with a mean age of 28.7 ± 6.2 years. Expansile and non-expansile ECI were identified in 5.4 and 4.3% of women, respectively. The proportion of women with high grade cytology recurrence was 10% for those with expansile ECI and 2.3% for those without. Multivariate analysis showed that women with expansile ECI when compared to those without, had a four-fold greater risk for high grade cytology recurrence (HR = 4.22; 95% CI: 1.10–16.29, p = 0.036). There was no significant association found between non-expansile ECI and overall or high grade cytology recurrence. The increased biopsy depth and the CIN3 grade of pretreatment cervical punch biopsies were significantly associated with greater odds for the detection of expansile ECI. We calculated that the optimal-cut off of pretreatment cervical punch biopsy depth for the detection of expansile ECI was 4 mm (sensitivity: 73.3%; specificity: 55.1%).
Conclusions: Expansile ECI is a risk factor that increases the likelihood of high grade cytology recurrence following cold coagulation. Deeper pretreatment cervical punch biopsies need to be taken so as not to miss expansile ECI prior to ablative treatment.

Link to full-text [open access - no password required]

The Incidence of and Predictors for Severe Perineal Trauma and Intact Perineum in Women Having a Waterbirth in England: A Hospital-Based Study (2021)

Posted on by

Type of publication:
Journal article

Author(s):
*Dimitrios Papoutsis, Angeliki Antonakou, *Adam Gornall, and Chara Tzavara

Citation:
Journal of Women's Health; May 2021; vol. 30 (no. 5); p. 681-688

Abstract:
Background: To determine the incidence of and predictors for obstetric anal sphincter injuries (OASIS) and intact perineum in women giving birth in the water and compare with the general obstetric population.
Materials and Methods: Data were retrospectively collected for women who had singleton cephalic presentation vaginal births in the water and the general obstetric population between August 2007 and December 2017.
Results: We identified 1,007 women who had a waterbirth and 36,924 women from the general obstetric population. There was no significant difference in the incidence of OASIS between waterbirths and the general obstetric population (2.3% vs. 2.0%). Having a waterbirth was associated with a lower probability for an intact perineum (odds ratio [OR] = 0.83; confidence interval [95% CI]: 0.73–0.94) when compared with the general obstetric population (44.7% vs. 51.3%). Nulliparous women with a waterbirth when compared with multiparous women had an eightfold higher likelihood for the occurrence of OASIS (OR = 8.28; 95% CI: 2.64–25.86). The risk for a higher degree of OASIS was associated with increased maternal age in the total sample (OR = 1.08; 95% CI: 1.06–1.11) and with a lower body mass index (BMI) at booking in multiparous women (OR = 0.96; 95% CI: 0.92–0.99). The risk for any type of perineal trauma was associated with increased maternal age in the total sample (OR = 1.10; 95% CI: 1.07–1.13) and with a lower BMI at booking in multiparous women (OR = 0.95; 95% CI: 0.91–0.99).
Conclusions: We found that giving birth in the water reduced the chance of having an intact perineum. We have also shown that nulliparity, increased maternal age in all women, and a lower BMI at booking in multiparous were associated with OASIS and lower rates of intact perineum in waterbirths.

Link to full-text [no password required]

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial (2020)

Posted on by

Type of publication:
Randomised controlled trial

Author(s):
Chu, Justin J; Devall, Adam J; Beeson, Leanne E; Hardy, Pollyanna; Cheed, Versha; Sun, Yongzhong; Roberts, Tracy E; Ogwulu, C Okeke; Williams, Eleanor; Jones, Laura L; La Fontaine Papadopoulos, Jenny H; Bender-Atik, Ruth; Brewin, Jane; Hinshaw, Kim; Choudhary, Meenakshi; Ahmed, Amna; Naftalin, Joel; Nunes, Natalie; Oliver, Abigail; Izzat, Feras; Bhatia, Kalsang; Hassan, Ismail; Jeve, Yadava; Hamilton, Judith; Deb, Shilpa; Bottomley, Cecilia; Ross, Jackie; Watkins, Linda; *Underwood, Martyn; Cheong, Ying; Kumar, Chitra S; Gupta, Pratima; Small, Rachel; Pringle, Stewart; Hodge, Frances; Shahid, Anupama; Gallos, Ioannis D; Horne, Andrew W; Quenby, Siobhan; Coomarasamy, Arri

Citation:
Lancet; Sep 2020; vol. 396 (no. 10253); p. 770-778

Abstract:
BACKGROUND The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.

Link to full-text [open access - no password required]

Altmetrics:

Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT (2020)

Posted on by

Type of publication:
Randomised controlled trial

Author(s):
Coomarasamy A.; Harb H.M.; Devall A.J.; Williams H.M.; Gallos I.D.; Ewer A.; Cheed V.; Roberts T.E.; Ogwulu C.B.; Middleton L.J.; Goranitis I.; Eapen A.; Daniels J.P.; Ahmed A.; Hinshaw K.; Bender-Atik R.; Bhatia K.; Bottomley C.; Kriedt K.; Jurkovic D.; Brewin J.; Choudhary M.; Crosfill F.; Deb S.; Duncan W.C.; Norman J.E.; Horne A.W.; Holland T.; Izzat F.; Johns J.; Ross J.; Lumsden M.-A.; Manda P.; Nunes N.; Overton C.E.; Quenby S.; Rao S.; Shahid A.; *Underwood M. ; Vaithilingham N.; Watkins L.; Wykes C.

Citation:
Health Technology Assessment (Winchester, England); Jun 2020; vol. 24 (no. 33); p. 1-70

Abstract:
BACKGROUND: Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage. OBJECTIVE(S): (1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding. DESIGN: A multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding. SETTING: A total of 48 hospitals in the UK. PARTICIPANTS: Women aged 16-39 years with early pregnancy bleeding. INTERVENTIONS: Women aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400mg of progesterone or a matched placebo from presentation to 16 weeks of gestation. MAIN OUTCOME MEASURES: The primary outcome was live birth at >=34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective. RESULT(S): A total of 4153 women from 48 hospitals in the UK received either progesterone (n=2079) or placebo (n=2074). The follow-up rate for the primary outcome was 97.2% (4038 out of 4153 participants). The live birth rate was 75% (1513 out of 2025 participants) in the progesterone group and 72% (1459 out of 2013 participants) in the placebo group (relative rate 1.03, 95% confidence interval 1.00 to 1.07; p=0.08). A significant subgroup effect (interaction test p=0.007) was identified for prespecified subgroups by the number of previous miscarriages: none (74% in the progesterone group vs. 75% in the placebo group; relative rate 0.99, 95% confidence interval 0.95 to 1.04; p=0.72); one or two (76% in the progesterone group vs. 72% in the placebo group; relative rate 1.05, 95% confidence interval 1.00 to 1.12; p=0.07); and three or more (72% in the progesterone group vs. 57% in the placebo group; relative rate 1.28, 95% confidence interval 1.08 to 1.51; p=0.004). A significant post hoc subgroup effect (interaction test p=0.01) was identified in the subgroup of participants with early pregnancy bleeding and any number of previous miscarriage(s) (75% in the progesterone group vs. 70% in the placebo group; relative rate 1.09, 95% confidence interval 1.03 to 1.15; p=0.003). There were no significant differences in the rate of adverse events between the groups. The results of the health economics analysis show that progesterone was more costly than placebo (7655 vs. 7572), with a mean cost difference of 83 (adjusted mean difference 76, 95% confidence interval -559 to 711) between the two arms. Thus, the incremental cost-effectiveness ratio of progesterone compared with placebo was estimated as 3305 per additional live birth at >=34 weeks of gestation. CONCLUSION(S): Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at >=34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 33. See the NIHR Journals Library website for further project information.

Link to full-text [no password required]

Altmetrics:

The Prevalence of Thyroid Dysfunction and Autoimmunity in Women With History of Miscarriage or Subfertility (2020)

Posted on by

Type of publication:
Journal article

Author(s):
Rima K Dhillon-Smith, Aurelio Tobias, Paul P Smith, Lee J Middleton, Kirandeep K Sunner, Krystyna Baker, Samantha Farrell-Carver, Ruth Bender-Atik, Rina Agrawal, Kalsang Bhatia, Justin J Chu, Edmond Edi-Osagie, Ayman Ewies, Tarek Ghobara, Pratima Gupta, Davor Jurkovic, Yacoub Khalaf, Khashia Mulbagal, Natalie Nunes, Caroline Overton, Siobhan Quenby, Raj Rai, Nick Raine-Fenning, Lynne Robinson, Jackie Ross, Andrew Sizer, Rachel Small, *Martyn Underwood , Mark D Kilby, Jane Daniels, Shakila Thangaratinam, Shiao Chan, Kristien Boelaert, Arri Coomarasamy

Citation:
The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 8, August 2020

Abstract:
Objective: To describe the prevalence of and factors associated with different thyroid dysfunction phenotypes in women who are asymptomatic preconception.
Design: Observational cohort study.
Setting: A total of 49 hospitals across the United Kingdom between 2011 and 2016.
Participants: Women aged 16 to 41 years with history of miscarriage or subfertility trying for a pregnancy.
Methods: Prevalences and 95% confidence intervals (CIs) were estimated using the binomial exact method. Multivariate logistic regression analyses were conducted to identify risk factors for thyroid disease.
Intervention: None.
Main Outcome Measure: Rates of thyroid dysfunction.
Results: Thyroid function and thyroid peroxidase antibody (TPOAb) data were available for 19213 and 19237 women, respectively. The prevalence of abnormal thyroid function was 4.8% (95% CI, 4.5-5.1); euthyroidism was defined as levels of thyroid-stimulating hormone (TSH) of 0.44 to 4.50 mIU/L and free thyroxine (fT4) of 10 to 21 pmol/L. Overt hypothyroidism (TSH > 4.50 mIU/L, fT4 < 10 pmol/L) was present in 0.2% of women (95% CI, 0.1-0.3) and overt hyperthyroidism (TSH < 0.44 mIU/L, fT4 > 21 pmol/L) was present in 0.3% (95% CI, 0.2-0.3). The prevalence of subclinical hypothyroidism (SCH) using an upper TSH concentration of 4.50 mIU/L was 2.4% (95% CI, 2.1-2.6). Lowering the upper TSH to 2.50 mIU/L resulted in higher rates of SCH, 19.9% (95% CI, 19.3-20.5). Multiple regression analyses showed increased odds of SCH (TSH > 4.50 mIU/L) with body mass index (BMI) ≥ 35.0 kg/m2 (adjusted odds ratio [aOR] 1.71; 95% CI, 1.13-2.57; P = 0.01) and Asian ethnicity (aOR 1.76; 95% CI, 1.31-2.37; P < 0.001), and increased odds of SCH (TSH ≥ 2.50 mIU/L) with subfertility (aOR 1.16; 95% CI, 1.04-1.29; P = 0.008). TPOAb positivity was prevalent in 9.5% of women (95% CI, 9.1-9.9).
Conclusions: The prevalence of undiagnosed overt thyroid disease is low. SCH and TPOAb are common, particularly in women with higher BMI or of Asian ethnicity. A TSH cutoff of 2.50 mIU/L to define SCH results in a significant proportion of women potentially requiring levothyroxine treatment.

Link to full-text [no password required]

Altmetrics:

Perioperative management of women on oral anticoagulants and antiplatelet agents undergoing gynaecological procedures (2020)

Posted on by

Type of publication:
Journal article

Author(s):
*Goh E.; Barker V.; Lee P.L.; *Eden D.; *Davies O.; *Sahu B.

Citation:
Obstetrician and Gynaecologist; 2020; Vol 22(2) p. 131-136

Abstract:
Key content: The number of women attending gynaecological services who are taking oral anticoagulants and antiplatelet agents is increasing. Direct oral anticoagulants are becoming increasingly popular and offer an alternative to warfarin. Knowledge of the use of anticoagulants in the perioperative period is imperative to provide optimal care and ensure patient safety. It is essential that health professionals practising gynaecology, at all levels, keep up to date to reduce unnecessary cancellations, delays in treatment and risks of thrombosis and bleeding. Learning objectives: To understand the management of women on oral anticoagulant and antiplatelet agents undergoing elective and emergency gynaecological procedures. To appreciate the importance of assessing patient- and procedural-related risks of thrombosis and bleeding. To review commonly used anticoagulant and antiplatelet agents.

Link to full-text [NHS OpenAthens account required]

Levothyroxine to increase live births in euthyroid women with thyroid antibodies trying to conceive: the TABLET RCT (2019)

Posted on by

Type of publication:
Journal article

Author(s):
Dhillon-Smith R K, Middleton L J, Sunner K K, Cheed V, Baker K, Farrell-Carver S, Bender-Atik R, Agrawal R, Bhatia K, Edi-Osagie E, Ghobara T, Gupta P, Jurkovic D, Khalaf Y, MacLean M, McCabe C, Mulbagal K, Nunes N, Overton C, Quenby S, Rai R, Raine-Fenning N, Robinson L, Ross J, Sizer A, Small R, Tan A, *Underwood M , Kilby M D, Boelaert K, Daniels J, Thangaratinam S, Chan S,  Coomarasamy A.

Citation:
Efficacy and Mechanism Evaluation; Volume: 6, Issue: 11, October 2019

Abstract:
Background: Thyroid autoantibodies, specifically thyroid peroxidase antibodies, have been associated with miscarriage and pre-term birth in women with a normal thyroid function. Small randomised controlled trials have found that treatment with levothyroxine may reduce such adverse outcomes in pregnancy.
Objectives: The Thyroid AntiBodies and LEvoThyroxine (TABLET) trial was conducted to explore the effects of levothyroxine in euthyroid women with thyroid peroxidase antibodies. A concurrent mechanistic study was conducted to examine the effect of levothyroxine on immune responses.
Design: This was a randomised, double-blind, placebo-controlled, multicentre study.
Setting: The TABLET trial was conducted in 49 hospitals across the UK between 2011 and 2016.
Participants: Euthyroid women who tested positive for thyroid peroxidase antibodies, were aged between 16 and 41 years and were trying to conceive either naturally or through assisted conception were eligible.
Intervention: Participants were randomised to levothyroxine at a dose of 50 µg daily or placebo. The intervention was commenced preconception and continued until the end of a pregnancy. Women were given a 12-month period to conceive from randomisation.
Main outcome measures: The primary outcome was live birth at ≥ 34 completed weeks of gestation. The secondary outcomes included miscarriage at < 24 weeks; clinical pregnancy at 7 weeks; ongoing pregnancy at 12 weeks; gestation at delivery; birthweight; appearance, pulse, grimace, activity and respiration (Apgar) scores; congenital abnormalities; and neonatal survival at 28 days of life.
Methods: Participants were randomised in a 1 : 1 ratio. Minimisation was implemented for age (< 35 or ≥ 35 years), number of previous miscarriages (0, 1 or 2, ≥ 3), infertility treatment (yes/no) and baseline thyroid-stimulating hormone concentration (≤ 2.5 or > 2.5 mlU/l) to achieve balanced trial arms. Women were followed up every 3 months while trying to conceive to check thyroid function and general well-being, and, once pregnant, were seen each trimester: 6–8 weeks, 16–18 weeks and 28 weeks. Any abnormal thyroid results were managed in line with clinical guidance at the time.
Results: Of the 19,556 women screened, 1420 women were eligible and 952 were randomised to receive levothyroxine (n = 476) or placebo (n = 476). Six women from each arm either were lost to follow-up or withdrew from the trial. A total 540 women became pregnant: 266 in the levothyroxine arm and 274 in the placebo arm. The live birth rate was 37% (176/470) in the levothyroxine group and 38% (178/470) in the placebo group, translating to a relative risk of 0.97 (95% confidence interval 0.83 to 1.14; p = 0.74) and an absolute risk difference of –0.4% (95% confidence interval –6.6% to 5.8%). A subset of 49 trial participants (26 in the levothyroxine arm and 23 in the placebo arm) were recruited to assess changes in their serum chemocytokine concentrations. Treatment with levothyroxine resulted in some changes in chemocytokine concentrations in the non-pregnant state and in early pregnancy, but these had no association with clinical outcome.
Conclusions: Levothyroxine therapy in a dose of 50 µg per day does not improve live birth rate in euthyroid women with thyroid peroxidase antibodies.
Limitations: Titration of the levothyroxine dose based on thyroid-stimulating hormone/thyroid peroxidase concentrations was not explored.
Future work: Future research could explore the efficacy of levothyroxine administered for the treatment of subclinical hypothyroidism.
Trial registration: Current Controlled Trials ISRCTN15948785 and EudraCT 2011-000719-19.
Funding: This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership.

Link to full-text [no password required]

Altmetrics:

The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM Trial (2020)

Posted on by

Type of publication:
Journal article

Author(s):
CB Okeke Ogwulu, I Goranitis, AJ Devall, V Cheed, ID Gallos, LJ Middleton, HM Harb, HM Williams, A Eapen, JP Daniels, A Ahmed, R Bender‐Atik, K Bhatia, C Bottomley, J Brewin, M Choudhary, S Deb, WC Duncan, AK Ewer, K Hinshaw, T Holland, F Izzat, J Johns, M Lumsden, P Manda, JE Norman, N Nunes, CE Overton, K Kriedt, S Quenby, S Rao, J Ross, A Shahid, *M Underwood , N Vaithilingham, L Watkins, C Wykes, AW Horne, D Jurkovic, A Coomarasamy, TE Roberts

Citation:
BJOG: An International Journal of Obstetrics and Gynaecology; May 2020; Vol 127 (no. 6); p. 757-767

Abstract:
Objectives: To assess the cost‐effectiveness of progesterone compared with placebo in preventing pregnancy loss in women with early pregnancy vaginal bleeding.
Design: Economic evaluation alongside a large multi‐centre randomised placebo‐controlled trial.
Setting: Forty‐eight UK NHS early pregnancy units.
Population: Four thousand one hundred and fifty‐three women aged 16–39 years with bleeding in early pregnancy and ultrasound evidence of an intrauterine sac.
Methods: An incremental cost‐effectiveness analysis was performed from National Health Service (NHS) and NHS and Personal Social Services perspectives. Subgroup analyses were carried out on women with one or more and three or more previous miscarriages.
Main outcome measures: Cost per additional live birth at ≥34 weeks of gestation.
Results: Progesterone intervention led to an effect difference of 0.022 (95% CI −0.004 to 0.050) in the trial. The mean cost per woman in the progesterone group was £76 (95% CI −£559 to £711) more than the mean cost in the placebo group. The incremental cost‐effectiveness ratio for progesterone compared with placebo was £3305 per additional live birth. For women with at least one previous miscarriage, progesterone was more effective than placebo with an effect difference of 0.055 (95% CI 0.014–0.096) and this was associated with a cost saving of £322 (95% CI −£1318 to £673).
Conclusions: The results suggest that progesterone is associated with a small positive impact and a small additional cost. Both subgroup analyses were more favourable, especially for women who had one or more previous miscarriages. Given available evidence, progesterone is likely to be a cost‐effective intervention, particularly for women with previous miscarriage(s).

Link to full-text [open access - no password required]

Altmetrics:

A method to improve the accuracy between the presumed depth of excision and the actual depth of excision in women (2018)

Posted on by

Type of publication:
Journal article

Author(s):
*Papoutsis D.; *Kandanearachchi P.; *Sahu B.; Antonakou A.; Tzavara C.

Citation:
Hippokratia; 2018; vol. 22 (no. 3); p. 113-121

Abstract:
Background: We aimed to determine whether continuous auditing of the presumed depth of excision and
comparing with the actual depth of excision in women having large loop excision of the transformation zone (LLETZ) improves the ability to acquire the desired depth of excision.
Method(s): This was a prospective study of women submitted to a single LLETZ treatment between 2017-2018. Two senior colposcopists recorded what they presumed was the depth of excision at the time of treatment and the subsequent histopathology report provided the actual excised depth. Multiple linear regression identified independently associated parameters with the difference between presumed and actual excision depth. Nonlinear regression determined the learning plateau defined as the theoretical minimal score of difference one could achieve with infinite practice.
Result(s): There were significant differences in practices with the first colposcopist using an 18-mm loop and the second colposcopist a 15-mm loop in the majority of cases. The median absolute and percentage difference between the presumed and actual excised depth was 2 mm and 16.6% and 3.5 mm and 35.4% for the two colposcopists, respectively. A learning plateau was identified only for the first colposcopist. We found that auditing consecutive excisions decreased significantly the difference between the presumed and actual depth of excision with a learning plateau at 2.2 mm of absolute difference and 22.6% of percentage difference and with a learning rate of 13 cervical excisions.
Conclusion(s): There might be a benefit in auditing our treatment practice as there seems to be a learning
plateau through this method

Link to full-text [open access - no password required]