Pregnancy complications

Babies in occiput posterior position are significantly more likely to require an emergency cesarean birth compared with babies in occiput transverse position in the second stage of labor: A prospective observational study (2020)

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Type of publication:
Journal article

Author(s):
Tempest, Nicola; Lane, Steven; Hapangama, Dharani; UK Audit Ressearch Trainee Collaborative in Obstetrics, Gynecology (UK-ARCOG) (*William Parry-Smith is a core committee member of UK-ARCOG)

Citation:
Acta Obstetricia et Gynecologica Scandinavica; Apr 2020; vol. 99 (no. 4); p. 537-545

Abstract:
INTRODUCTION Malposition complicates 2-13% of births at delivery, leading to increased obstetric interventions (cesarean section and instrumental delivery) and higher rates of adverse fetal and maternal outcomes. Limited data are available regarding the likely rates of obstetric intervention and subsequent neonatal and maternal outcomes of births with babies in persistent occiput posterior position vs those in persistent occiput transverse position. The UK Audit and Research trainee Collaborative in Obstetrics and Gynecology (UK-ARCOG) network set out to collect data prospectively at delivery on final mode of delivery and immediate outcomes.MATERIAL AND METHODS The UK-ARCOG network collected data on all births with malposition of the fetal head complicating the second stage of labor (n = 838) (occiput posterior/occiput transverse) requiring rotational vaginal operative birth or emergency cesarean to expedite delivery across 66 participating UK National Health Service maternity units over a 1-month period. The outcomes considered were the need for emergency cesarean section without a trial of instrumental delivery, success of the first method of delivery employed in achieving a vaginal delivery and neonatal/maternal outcomes.RESULTS Obstetricians regarded assistance with an operative vaginal delivery method to be unsafe in 15% of babies in occiput posterior position and 6.1% of babies in occiput transverse position, and they were delivered by primary emergency cesarean section. When vaginal delivery was deemed safe (defined as attempted assisted vaginal rotational delivery), the first instrument attempted was successful in 74.4% of occiput posterior babies and 79.3% of occiput transverse babies.CONCLUSIONS Our data facilitates decision making by obstetricians to increase safety of assisted rotational operative delivery of a malpositioned baby at initial assessment and in counseling women. Until data from a well-designed randomized controlled trial of instrumental delivery vs emergency cesarean section are available, this manuscript provides contemporaneous national data from a high resource setting within a structured training program, to assist the selection of an appropriate instrument/method for the delivery of a malpositioned baby.

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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.

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

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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.

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Reflective doctors and cool babies (2019)

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Type of publication:
Conference abstract

Author(s):
*Charlesworth D.; Cunningham S.; Dudley L.; Bentley F.; Oguntimehin J.; Fairclough S.

Citation:
BJOG: An International Journal of Obstetrics and Gynaecology; Jun 2019; vol. 126 ; p. 45

Abstract:
Introduction In 2014, the RCOG launched the 'Each Baby Counts' initiative which included the aim of reducing the number of neonates who are left severely disabled by preventable incidents in labour. The initial report concluded that a different outcome may have been achieved in 76% of cases if different care had been received. Around the same time, reflective practice among doctors faced a significant challenge secondary to negative perceptions of its use in litigation, and resilience continued to be tested as work pressures, insufficient staff numbers, and public perceptions continued to increase. With the interplay between all these factors being crucial in achieving the state of experiential learning necessary to achieve the EBC goals, we look at a different method for reflective practice and quality improvement. Methods In 2015, we launched a series of measures inspired by EBC to reduce our rates of neonates requiring therapeutic hypothermia. One key component of our programme was a change in how our RCAs were undertaken. We changed RCA leads to include staff at all levels from across the multidisciplinary team, promoted a reflective journey and thematic analysis, changed our meetings to include staff recommended by the EBC report to achieve a more multidisciplinary and inclusive representation, promoted team learning, and fed back via casebased, reflective teaching. We then undertook a 48-month retrospective audit from 01/2015 to 12/2018 to see if we had improved care. Results In 2015, our therapeutic hypothermia annual incidence was 12, 11 in 2016, 7 in 2017, and 2 by 12/2018. Thematic analysis of our cases revealed a change in precipitating factors from preventable to unpredictable, and we subsequently increased the proportion of cases in which we concluded we could not improve the end outcome (though learning was identified in all). Staff empowerment increased, hierarchies flattened, and our ability to identify key targeted improvements increased to facilitate change and drive improvement. Conclusion We discovered that, if conducted well, with reflection as a key component, and the aim to promote a culture of learning and becoming, RCA can be used as a powerful teaching tool in training, and to promote improved patient care. As more staff engaged in our new RCA process, feedback indicated an increase in resilience and a more open culture of learning, unhindered by more traditional elements of reflective learning.

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A national survey on the uterotonic use for the prevention of postpartum haemorrhage (2019)

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Type of publication:
Conference abstract

Author(s):
*Stephanou M.; Gallos I.; Coomarasamy A.

Citation:
BJOG: An International Journal of Obstetrics and Gynaecology; Jun 2019; vol. 126 ; p. 148-149

Abstract:
Objective: To map the current national practice of the first line uterotonic drug given for the prevention of
postpartum haemorrhage (PPH) at both vaginal and caesarean section deliveries. Design A prospective national survey was carried out by contacting maternity units by means of telephone contact. Survey questions were set out to evaluate the uterotonic drug of choice in accordance with local hospital policy which was then compared with national guidance.
Methods: Maternity units across England were identified using the NHS Maternity Statistics 2016-2017 data available from NHS Digital. 136 NHS trusts were identified and 143 maternity units were contacted. Responses were collected by means of telephone communication with each of the maternity units. Maternity governance leads were the first point of contact followed by labour ward coordinators and senior labour ward doctors. The Health Research Authority Ethics toolkit was applied and determined that Research and Ethics council approval was not required.
Results: All 143 maternity units identified were contacted to answer the survey. 118 (82.5%) responses were obtained for the uterotonic of choice used for the prevention of postpartum haemorrhage at vaginal birth, of which 75 (63.5%) maternity units administered oxytocin with ergometrine combination as the first-line uterotonic. 116 (81%) responses were collected for the uterotonic of choice at caesarean section, where 95 (81.9%) administered intravenous oxytocin as first line.
Conclusion: The National Institute of Clinical Excellence (NICE) and World Health Organization (WHO)
guidelines recommend oxytocin as the first-line uterotonic of choice for the prevention of postpartum
haemorrhage. This survey has shown that current UK practice conflicts with both international and national guidance, favouring oxytocin with ergometrine over oxytocin alone at vaginal birth. Postpartum haemorrhage is a significant cause of morbidity and mortality; it is recommended that further attention be paid towards the first line uterotonic agent used for the prevention of a PPH in line with the most current up to date evidence.

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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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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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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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