Obstetrics and Gynaecology

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy (2019)

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Type of publication:
Randomised controlled trial

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

Citation:
New England Journal of Medicine 2019;380:p.1815-24.

Abstract:
BACKGROUND
Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy.
METHODS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. Women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily, from the time at which they presented with bleeding through 16 weeks of gestation. The primary outcome was the birth of a live-born baby after at least 34 weeks of gestation. The primary analysis was performed in all participants for whom data on the primary outcome were available. A sensitivity analysis of the primary outcome that included all the participants was performed with the use of multiple imputation to account for missing data.
RESULTS
A total of 4153 women, recruited at 48 hospitals in the United Kingdom, were randomly assigned to receive progesterone (2079 women) or placebo (2074 women). The percentage of women with available data for the primary outcome was 97% (4038 of 4153 women). The incidence of live births after at least 34 weeks of gestation was 75% (1513 of 2025 women) in the progesterone group and 72% (1459 of 2013 women) in the placebo group (relative rate, 1.03; 95% confidence interval [CI], 1.00 to 1.07; P=0.08). The sensitivity analysis, in which missing primary outcome data were imputed, resulted in a similar finding (relative rate, 1.03; 95% CI, 1.00 to 1.07; P=0.08). The incidence of adverse events did not differ significantly between the groups.
CONCLUSIONS
Among women with bleeding in early pregnancy, progesterone therapy administered during the first trimester did not result in a significantly higher incidence of live births than placebo. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment program; PRISM Current Controlled Trials number, ISRCTN14163439.)

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Levothyroxine in Women with Thyroid Peroxidase Antibodies before Conception (2019)

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Type of publication:
Randomised controlled trial

Author(s):
Dhillon-Smith, Rima K; Middleton, Lee J; Sunner, Kirandeep K; Cheed, Versha; Baker, Krys; Farrell-Carver, Samantha; Bender-Atik, Ruth; Agrawal, Rina; Bhatia, Kalsang; Edi-Osagie, Edmond; Ghobara, Tarek; Gupta, Pratima; Jurkovic, Davor; Khalaf, Yacoub; MacLean, Marjory; McCabe, Christopher; Mulbagal, Khashia; Nunes, Natalie; Overton, Caroline; Quenby, Siobhan; Rai, Raj; Raine-Fenning, Nick; Robinson, Lynne; Ross, Jackie; *Sizer, Andrew; Small, Rachel; Tan, Alex; *Underwood, Martyn ; Kilby, Mark D; Boelaert, Kristien; Daniels, Jane; Thangaratinam, Shakila; Chan, Shiao Y; Coomarasamy, Arri

Citation:
The New England Journal of Medicine Apr 2019; 380 (no. 14); p. 1316-1325

Abstract:
BACKGROUND Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could reduce the incidence of such adverse outcomes. METHODS We conducted a double-blind, placebo-controlled trial to investigate whether levothyroxine treatment would increase live-birth rates among euthyroid women who had thyroid peroxidase antibodies and a history of miscarriage or infertility. A total of 19,585 women from 49 hospitals in the United Kingdom underwent testing for thyroid peroxidase antibodies and thyroid function. We randomly assigned 952 women to receive either 50 μg once daily of levothyroxine (476 women) or placebo (476 women) before conception through the end of pregnancy. The primary outcome was live birth after at least 34 weeks of gestation. RESULTS The follow-up rate for the primary outcome was 98.7% (940 of 952 women). A total of 266 of 470 women in the levothyroxine group (56.6%) and 274 of 470 women in the placebo group (58.3%) became pregnant. The live-birth rate was 37.4% (176 of 470 women) in the levothyroxine group and 37.9% (178 of 470 women) in the placebo group (relative risk, 0.97; 95% confidence interval [CI], 0.83 to 1.14, P = 0.74; absolute difference, -0.4 percentage points; 95% CI, -6.6 to 5.8). There were no significant between group differences in other pregnancy outcomes, including pregnancy loss or preterm birth, or in neonatal outcomes. Serious adverse events occurred in 5.9% of women in the levothyroxine group and 3.8% in the placebo group (P = 0.14). CONCLUSIONS The use of levothyroxine in euthyroid women with thyroid peroxidase antibodies did not result in a higher rate of live births than placebo. (Funded by the United Kingdom National Institute for Health Research; TABLET Current Controlled Trials number, ISRCTN15948785.).

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Cited by 94 other articles

Evaluating the value of intrapartum fetal scalp blood sampling to predict adverse neonatal outcomes: A UK multicentre observational study (2019)

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Type of publication:
Journal article

Author(s):
Al Wattar, Bassel H; Lakhiani, Aarti; Sacco, Adalina; Siddharth, Aditi; Bain, Alexandra; Calvia, Alexandra; Kamran, Atiyah; Tiong, Bing; Warwick, Bethan; MacMahon, Caroline; Marcus, Diana; Long, Emma; Coyle, Gillian; Lever, Gillian Elizabeth; Michel, Gina; Gopal, Gomathy; Baig, Hana; Price, Hannah Louise; Badri, Hawra; Stevenson, Helen; Hoyte, Helene; Malik, Humaira; Edwards, Jade; Hartley, Jennifer; Hemers, Jennifer; Tamblyn, Jennifer; Dalton, John Alexander William; Frost, Jonathan; Subba, Kamana; Baxter, Kathryn; Sivakumar, Kavitha; Murphy, Kelly; Papadakis, Konstantinos; Bladon, Laura Rachel; Kasaven, Lorraine; Manning, Louisa; Prior, Mathew; Ghosh, Mausumi; Couch, Melanie; Altunel, Melis; Pearce, Melissa; Cocker, Michael; Stephanou, Michael; Jie, Michelle; Mistry, Minesh; Wahby, Mohammed Osama; Saidi, Nabila Shahid; Ramshaw, Nicola Louise; Tempest, Nicola; Parker, Nina; Tan, Phoebe L; Johnson, Racheal Louise; Harris, Rachel; Tildesley, Rachel; Ram, Ramya; Painuly, Ritu; Cuffolo, Romana; Bugeja, Roberta; Ngadze, Rose; Grainger, Rosie; Gurung, Sabitra; Mak, Sammy; Farrell, Sara; Cowey, Sarah; Neary, Sarah; Quinn, Sarah; Nijjar, Simrit Kaur; Kenyon, Sophie; Lamb, Stephanie; Tracey, Susan; Lee, Tara; Kinsella, Therese; Davidson, Trecia; Corr, Trent; Sampson, Uzo; McQueen, Victoria; *Parry-Smith, William; Castling, Zora; AB-FAB study group

Citation:
European Journal of Obstetrics, Gynecology, and Reproductive Biology; Sep 2019; vol. 240 ; p. 62-67

Abstract:
OBJECTIVE To evaluate the value of fetal scalp blood sampling (FBS) as an adjunct test to cardiotocography, to predict adverse neonatal outcomes. STUDY DESIGN A multicentre service evaluation observational study in forty-four maternity units in the UK. We collected data retrospectively on pregnant women with singleton pregnancy who received FBS in labour using a standardised data collection tool. The primary outcome was prediction of neonatal acidaemia diagnosed as umbilical cord arterial pH < 7.05, the secondary outcomes were the prediction of Apgar scores<7 at 1st and 5th minutes and admission to the neonatal intensive care unit (NICU). We evaluated the correlation between the last FBS blood gas before birth and the umbilical cord blood and adjusted for time intervals. We constructed 2 × 2 tables to calculate the sensitivity, specificity, positive (PPV) and negative predictive value (NPV) and generated receiver operating curves to report on the Area Under the Curve (AUC). RESULTS In total, 1422 samples were included in the analysis; pH values showed no correlation (r = 0.001, p = 0.9) in samples obtained within an hour (n = 314), or within half an hour from birth (n = 115) (r=-0.003, p = 0.9). A suboptimal FBS pH value (<7.25) had a poor sensitivity (22%) and PPV (4.9%) to predict neonatal acidaemia with high specificity (87.3%) and NPV (97.4%). Similar performance was noted to predict Apgar scores <7 at 1st (sensitivity 14.5%, specificity 87.5%, PPV 23.4%, NPV 79.6%) and 5th minute (sensitivity 20.3%, specificity 87.4%, PPV 7.6%, NPV 95.6%), and admission to NICU (sensitivity 20.3%, specificity 87.5%, PPV 13.3%, NPV 92.1%). The AUC for FBS pH to predict neonatal acidaemia was 0.59 (95%CI 0.59-0.68, p = 0.3) with similar performance to predict Apgar scores<7 at 1st minute (AUC 0.55, 95%CI 0.51-0.59, p = 0.004), 5th minute (AUC 0.55, 95%CI 0.48-0.62, p = 0.13), and admission to NICU (AUC 0.58, 95%CI 0.52-0.64, p = 0.002). Forty-one neonates had acidaemia (2.8%, 41/1422) at birth. There was no significant correlation in pH values between the FBS and the umbilical cord blood in this subgroup adjusted for sampling time intervals (r = 0.03, p = 0.83). CONCLUSIONS As an adjunct tool to cardiotocography, FBS offered limited value to predict neonatal acidaemia, low Apgar Scores and admission to NICU.

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Perivascular epitheloid cell tumor and mesonephric adenocarcinoma of the uterine cervix: an unknown co-existence (2019)

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Type of publication:
Journal article

Author(s):
*Dimitrios Papoutsis, *Banchhita Sahu, *Joanna Kelly, Angeliki Antonakou

Citation:
Oxford Medical Case Reports, Volume 2019, Issue 1, January 2019

Abstract:
A 67-year-old woman with post-menopausal bleeding and a suspicious endocervical mass was referred to gynaecology outpatients’ for diagnosis and management. Cervical punch biopsies taken showed a benign cervical perivascular epithelioid cell tumour (PEComa), with MRI imaging and PET-CT scan indicating a 3–4 cm endocervical tumour with malignant features. The patient underwent radical hysterectomy with lymph node dissection and the surgical specimen histopathology demonstrated a residual benign PEComa and a stage IIB mesonephric adenocarcinoma (MNA) of the cervix. There is no disease recurrence 12 months after surgery. Cervical PEComas are extremely rare tumours of mesenchymal origin deriving from the perivascular epithelioid cells with only 14 cases described so far. Cervical MNAs are rare tumours originating from the remnants of the mesonephric duct of Wolff with only 40 cases reported. Our case adds to the existing literature and highlights the challenges with regard to preoperative diagnosis, treatment and prognosis.

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Audit of 2-week wait referrals to the Gynecology Department in District General Hospital and investigating patient awareness of the reasons and importance behind the referral (2018)

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Type of publication:
Conference abstract

Author(s):
Wilkinson M.; *Sahu B

Citation:
BJOG: An International Journal of Obstetrics and Gynaecology; Dec 2018; vol. 125 ; p. 48

Abstract:
Introduction Two-week wait referrals to gynecology services are at a premium with pressure on numbers. Referrals can be inappropriate. Patients are often unaware the appointment is for suspected cancer. Methods Two-week wait referrals were examined during a six month period. The gynecologist in clinic collected data. Patients were asked about their 2-week wait referral, gauging awareness around their referral. Clinical symptoms and signs were compared to those in referral. Appropriateness of the referral was assessed by symptoms fitting the 2-week wait criteria or clinical findings on referral not consistent with the presenting symptoms and findings in clinic. Results A total of 172 patients were referred under the 2-week wait criteria; mean age was 58 years, range (17-95). Referrals were from 50 separate primary care practices. Suspected cancer referrals were composed of 111 endometrial, 15 ovarian, 22 cervical, 15 vulva/vaginal and 9 of mixed pathology. There was awareness of referral for cancer in 90 cases (52%), awareness of "2-week wait" in 124 cases (72%) and aware that the appointment could be at either hospital within the trust in 96 cases (56%). The referral was considered appropriate for 2-week wait referral in 123 (72%) of cases. Conclusion The majority of patients were referred correctly. A wide range of pathologies was seen. A significant number could have been referred as routine referrals or advice requested. Patient awareness of it being a referral due to suspected cancer was poor with better appreciation of the urgency of referral.

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A survey of management of vulvar disorders in the primary health care setting in an urban area of England (2018)

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Type of publication:
Journal article

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

Citation:
Archives of Hellenic Medicine; 2018; vol. 35 (no. 3); p. 405-411

Abstract:
OBJECTIVE To determine the frequency of consultation for vulvar diseases in the primary health care setting, and their investigation and management patterns, and to identify the training needs of general practitioners (GPs) in vulvar disease. METHOD A survey was conducted using a 13-item questionnaire handed out to GPs during their regional post-graduate seminars in the area of Shropshire in the West Midlands in England. RESULTS Of 120 questionnaires distributed, a total of 107 responses were received (response rate: 89.1%). Of the participants, 67.3% reported that they see more than 5 patients per month with vulvar symptoms, and 24.6% that they see more than 5 patients per month with recurrent vulvar symptoms. The predominant symptom was pruritus vulvae (77.5%), with 94.5% of practitioners considering lichen sclero-sus as the most likely diagnosis. For recurrent pruritus vulvae a gynecological referral was made in most cases (86%). In contrast, when there was vulvar pain, only few practitioners would refer the patient to a gynecologist (8.4%) or a dermatologist (17.3%). Only 41.1% of GPs had ever received any kind of training, with all (100%) agreeing that formal training in the diagnosis and management of vulvar diseases would benefit their care of their patients. CONCLUSIONS This survey showed that a substantial number of women consult their GP with vulvar symptoms. A variety of approaches were reported in the diagnosis and management of these cases. All the GPs agreed that there is a need for formal training in vulvar disease.

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The paediatrician and the management of common gynaecological conditions (2018)

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Type of publication:
Journal article

Author(s):
*Ritchie, Joanne K; Latthe, Pallavi; Jyothish, Deepthi; Blair, Joanne C

Citation:
Archives of disease in childhood; Jul 2018, 103(7), p. 703-706

Abstract:
Paediatric gynaecology is an emerging discipline. Since 2000, there has been an advanced training programme in paediatric gynaecology available for obstetric and gynaecology trainees; additionally, a set of clinical standards1 for the care of paediatric and adolescent patients has been developed by The British Society of Paediatric and Adolescent Gynaecology (BritSPAG). BritSPAG is a multidisciplinary group of professionals including gynaecologists, paediatricians, paediatric urologists and endocrinologists.Girls with gynaecological conditions are often seen in general paediatric services; it is important that those assessing them are confident in identifying patients who require more specialist care. Despite this, gynaecology does not appear in the Royal College of Paediatrics and Child Health curriculum. This article aims to increase the knowledge base and confidence of paediatricians in dealing with common paediatric and adolescent gynaecological conditions.

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Early and late pregnancy outcomes in women treated with cold-coagulation versus LLETZ cervical treatment for cervical intraepithelial neoplasia; a retrospective cohort study (2018)

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Type of publication:
Journal article

Author(s):
*Papoutsis, Dimitrios; *Underwood, Martyn ; *Parry-Smith, William; *Panikkar, Jane

Citation:
Archives of Gynecology and Obstetrics; Apr 2018; Vol.297(4):1015-1025

Abstract:
PURPOSE To compare the pregnancy outcomes between women who were treated with cold-coagulation versus large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia. METHODS This was a retrospective cohort study of women who had a single cervical treatment between 2010 and 2011. We identified those women who had a singleton pregnancy subsequent to their cervical treatment until September 2017. Women with previous cervical treatment, previous miscarriage or preterm delivery were excluded. RESULTSWe identified 86 women with a pregnancy after LLETZ treatment and 75 women after cold coagulation. Those who had LLETZ when compared to cold coagulation miscarried more often in the first trimester (33.7 vs 17.3%; p = 0.01) than in the second trimester. In women with LLETZ this effect of increased early miscarriage was shown to be prolonged and to persist up to 17 months after excision. Women with LLETZ when compared to cold coagulation had higher spontaneous preterm birth rates (8.9 vs 6.7%) even though the difference was non significant, with the earliest spontaneous preterm birth occurring at 32 weeks and 34 weeks, respectively. CONCLUSION We found that women who received LLETZ treatment when compared to cold coagulation had higher spontaneous preterm birth rates in their subsequent pregnancy and miscarried more frequently in the first trimester, and demonstrated an increased early miscarriage risk that persisted for more than a year after excisional treatment.

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