Obstetrics and Gynaecology

The FAST-M complex intervention for the detection and management of maternal sepsis in low-resource settings: a multi-site evaluation (2021)

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Type of publication:
Journal article

Author(s):
Cheshire, James; Jones, Laura; Munthali, Laura; Kamphinga, Christopher; Liyaya, Harry; Phiri, Tarcizius; *Parry-Smith, William; Dunlop, Catherine; Makwenda, Charles; Devall, Adam James; Tobias, Aurelio; Nambiar, Bejoy; Merriel, Abi; Williams, Helen Marie; Gallos, Ioannis; Wilson, Amie; Coomarasamy, Arri; Lissauer, David

Citation:
BJOG : an international journal of obstetrics and gynaecology; Jul;128(8):1324-1333

Abstract:
OBJECTIVE To evaluate whether the implementation of the FAST-M complex intervention was feasible and improved the recognition and management of maternal sepsis in a low-resource setting.DESIGNA before and after design.SETTINGFifteen government healthcare facilities in Malawi.POPULATION Women suspected of having maternal sepsis.METHODS The FAST-M complex intervention consisted of the following components: i) the FAST-M maternal sepsis treatment bundle and ii) the FAST-M implementation programme. Performance of selected process outcomes were compared between a two month baseline phase and six month intervention phase with compliance used as a proxy measure of feasibility.MAIN OUTCOME RESULT Compliance with vital sign recording and use of the FAST-M maternal sepsis bundle.RESULTS Following implementation of the FAST-M intervention, women were more likely to have a complete set of vital signs taken on admission to the wards (0/163 (0%) vs. 169/252 (67.1%), p<0.001). Recognition of suspected maternal sepsis improved with more cases identified following the intervention (12/106 (11.3%) vs. 107/166 (64.5%), p<0.001). Sepsis management improved, with women more likely to receive all components of the FAST-M treatment bundle within one hour of recognition (0/12 (0%) vs. 21/107 (19.6%), p=0.091). In particular women were more likely to receive antibiotics (3/12 (25.0%) vs. 72/107 (67.3%), p=0.004) within one hour of recognition of suspected sepsis.CONCLUSION Implementation of the FAST-M complex intervention was feasible and led to the improved recognition and management of suspected maternal sepsis in a low-resource setting such as Malawi.

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Obstetric and gynaecology trainees’ knowledge of paediatric and adolescent gynaecology services in the UK: A national qualitative thematic analysis (2019)

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Type of publication:
Journal article

Author(s):
*Ritchie, J K; *Sahu, B; Wood, P L

Citation:
European Journal of Obstetrics, Gynecology, and Reproductive Biology; Apr 2019; vol. 235 ; p. 30-35

Abstract:
BACKGROUND: The British Society of Paediatric and Adolescent Gynaecology (BritSPAG) was created in 2000 with specific aims to include raising the profile of paediatric and adolescent gynaecology (PAG) within the United Kingdom (UK). The Society has since developed a set of clinical standards for all acute hospitals providing gynaecological services to enable successful provision of paediatric and adolescent gynaecology care.AIMSTo determine the depth of knowledge that obstetric and gynaecology trainees have with regards to the PAG services provided at their Hospital, reflecting how widely PAG services have had an impact on trainees.METHOD: The national survey was distributed to all deaneries in the UK for circulation to all their trainees via e mail during Nov 2017-March 2018.RESULTS: 28% of the trainees said there was a PAG clinic at their hospital, 46.9% did not have a clinic and 24.7% were unsure. 41.6% of the respondents were aware of BritSPAG, however only 10.4% were aware of the BritSPAG clinical standards for service planning with regards to PAG clinics. Nearly half were aware of the PAG specialist centre for their region but only 6.5% were aware of the BritSPAG UK map of services. A large majority (93.24%) didn't believe that trainees in O&G received adequate exposure to PAG in their training.CONCLUSION: This study represents the largest and first national survey to seek obstetric and gynaecology trainees' thoughts on the provision of PAG training in the UK today. Given that only 28% of trainees answering said that they were aware of a PAG clinic at their hospital, this indicates not only that many hospitals did not have a dedicated PAG clinic but more worryingly five of the trainees were not aware of the existence of a confirmed PAG clinic at their hospital, and therefore are potentially losing out on training opportunities. Disappointingly the results of our survey reveal that trainees in Obstetrics and Gynaecology still have very little experience or exposure to PAG during their training despite there being opportunities to do so.

Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study (2021)

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Type of publication:
Randomised controlled trial

Author(s):
Jason Yap, Daniel Slade, Harriet Goddard, Christopher Dawson, Raji Ganesan, Shireen Velangi, *Banchhita Sahu, Baljit Kaur, Ana Hughes, David Luesley

Citation:
BJOG 2021 May;128(6):1047-1055

Abstract:
Objective To compare the safety and efficacy of Veregen® ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design A Phase II randomised control trial. Setting A tertiary gynaecological oncology referral center. Population All women diagnosed with primary and recurrence uVIN. Methods Eligible patients were randomised to receive either Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures Outcome measures, recorded at 16 and 32 weeks, were histological (HR) and clinical (CR) response (as measured by ≥30% reduction in the sum of the longest diameter of all lesions when compared to baseline), toxicity and changes in quality of life and pain scores. Results 26 patients were randomised and all 13 patients who received Veregen® showed either complete (n=5) or partial (n=8) CR with a trend towards an improvement in baseline symptoms. In placebo group, 3 patients had complete CR, 2 had partial CR and 6 had stable disease. Patients in the Veregen® group showed a significant improvement in CR as compared to the placebo group (P=0.0026). There was no evidence of difference in HR and toxicity reported in both groups. Conclusion Our study indicates that Veregen application is safe and leads to at least a partial clinical resolution of uVIN lesions and symptoms improvement, thus warranting a phase III multi-centre RCT.

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Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial (2021)

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Type of publication:
Randomised controlled trial

Author(s):
Ayman Ewies, Ikhlaq Ahmed, Farook Alazzawi, Joan Pitkin, Pratima Gupta, Mojca Persic, *Banchhita Sahu, Alaa El-Ghobashy, Lisa Barraclough, Jacqueline Woodman, Jaspreet Babrah, Sarah Bowdem, Deborah Stocken, Lucinda Billingham, Sudha Sundar, Daniel Rea

Citation:
BJOG; November 2021; Volume128, Issue12, Pages 2024-2033

Abstract:
Objective: To assess whether folic acid supplementation ameliorates hot flushes. Design: Double-blind, placebo-controlled randomised trial. Setting: Nine hospitals in England. Population: Postmenopausal women experiencing ≥50 hot flushes weekly. Methods: Women (n=164) were randomly assigned in a 1:1 ratio to receive folic acid 5mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4-weekly intervals. Main Outcome Measures: The change in daily Hot Flush Score at week-12 from randomisation based on Sloan Diary Composite Score B calculation. Results: Data of 143 (87%) women was available for the primary outcome. The mean change (SD) in Hot Flush Score at week-12 was -6.98 (10.30) and -4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was -2.41 (95% CI: -5.68, 0.87), p=0.149 and in the adjusted mean change was -2.61 (95% CI: -5.72, 0.49) with p=0.098. There was an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week-8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI: 1.16, 9.28) and 1.88 (95% CI: 0.23, 3.52) for total and emotional score, respectively. Conclusions: Folic acid had a greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo; however, the difference did not reach statistical significance. Definitive evidence of benefit requires a larger study.

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Short statured primigravidae: Options for the obstetric management from a survey of UK obstetricians (2021)

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Type of publication:
Journal article

Author(s):
*Rachaneni S.; Gurol-Urganci I.; Basu M.; Thakar R.; Sultan A.; Freeman R.

Citation:
European Journal of Obstetrics Gynecology and Reproductive Biology; Jan 2021; vol. 256 ; p. 379-384

Abstract:
Objective: To assess the current antenatal and intrapartum management options for primigravid women of short stature with a clinically large fetus by a survey of UK Obstetricians. Study design: An online survey comprised of 15 questions including the options on timing and mode of delivery, counselling about the risk of long-term pelvic floor morbidity following spontaneous vaginal and instrumental deliveries, choice of instruments and the role of episiotomy. The survey was sent to the participants as a part of Royal College of Obstetricians and Gynaecologists (RCOG) Newsletter between September 2017 to October 2018. The scenario described was of a primigravid short stature woman (i.e. height of 160 cm or less) who presents with a clinically large fetus at 38 weeks gestation. Result(s): 424 Obstetricians participated in the survey. The participation ratio cannot be identified as the survey was emailed as a part of the RCOG Newsletter. Sixty five percent respondents stated that they would scan for estimated fetal weight, 48 % would offer induction of labour at 40 weeks and 14 % would offer an elective/planned caesarean section (CS) at 39-40 weeks. Fifty nine percent would discuss all these risks: obstructed labour, shoulder dystocia, instrumental delivery and obstetric anal sphincter injury (OASI). 73 % would not discuss the long-term risks of urinary and/or faecal incontinence and pelvic organ prolapse. In the presence of failure to progress in the second stage of labour, 69 % would attempt a rotational instrumental delivery and 5% would offer a caesarean section. Manual rotation and 'straight' forceps application were the most frequent type of rotational delivery, followed by Ventouse and Kiellands forceps. Thirty four percent stated that they do not routinely perform an episiotomy in this scenario. Seventy three percent stated that their choice of instrument was not based on the long-term risk of urinary and faecal incontinence. Conclusion(s): The results suggest that 40 % of the respondents would not discuss all of the complications after vaginal delivery in women of short stature. The most common delivery option would be vaginal delivery.

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

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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.

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

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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.

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

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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.

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

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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.

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