Induction of labour for predicted macrosomia: study protocol for the 'Big Baby' randomised controlled trial (2022)

Type of publication:Journal article

Author(s):Ewington LJ; Gardosi J; Lall R; Underwood M; Fisher JD; Wood S; Griffin R; Harris K; Bick D; Booth K; Brown J; Butler E; Fowler K; Williams M; *Deshpande S; *Gornall A; Dewdney J; Hillyer K; Gates S; Jones C; Mistry H; Petrou S; Slowther AM; Willis A; Quenby S

Citation:BMJ Open, 2022 Nov 11; Vol. 12 (11), pp. e058176. Date of Electronic Publication: 2022 Nov 11.

Abstract:Introduction: Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0-38+4 weeks' gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia.Methods and Analysis: The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks' gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks' gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included.

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Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study (2022)

Type of publication:Journal article

Author(s):Mullins E; Perry A; Banerjee J; Townson J; Grozeva D; Milton R; Kirby N; Playle R; Bourne T; Lees C; PAN-COVID Investigators (including *Millward, H.)

Citation:European Journal of Obstetrics, Gynecology, and Reproductive Biology, 2022 Sep; Vol. 276, pp. 161-167.

Abstract:Objective: To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection.Methods: Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant.Results: Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3-1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2.Conclusions: Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians' threshold for delivery should be low if there are concerns with fetal movements or fetal heart rate monitoring in the time around infection. The proportion affected by pre-eclampsia amongst participants was not higher than would be expected, although we report a higher than expected proportion affected by eclampsia. There appears to be no effect on birthweight or congenital malformations in women affected by SARS-CoV-2 infection in pregnancy and neonatal infection is uncommon. This study reflects a population with a range of infection severity for SARS-COV-2 in pregnancy, generalisable to whole obstetric populations.

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Recurrence of a second trimester fundal uterine rupture at the old scar site: A case report (2022)

Type of publication:Journal article

Author(s):*Panesar H.; *Patel R.; Dhaliwal H.

Citation:Radiology Case Reports. 17(11) (pp 4445-4448), 2022. Date of Publication: November 2022.

Abstract:Uterine rupture is a rare life-threatening complication. It can occur in all 3 trimesters with the first and the second being a rarity. It mainly occurs in the third trimester or during labor in a previously scarred uterus. It is rare in an unscarred uterus. The risk fold is further enhanced by the induction and augmentation with prostaglandins and oxytocin. The clinical diagnosis at this early gestation can be a dilemma to the attending physician as in this case. (1) The patient was a holidaymaker with no documented evidence of a dating scan to suggest any evidence of an ovarian/placental pathology at that stage. (2) The ultrasound findings in our department did suggest a viable intrauterine pregnancy with free fluid within both the adnexa. A 6 cm solid homogenous mass in the midline/right adnexa suggested an ovarian torsion or bowel pathology. The differentials in this particular case were that of a ruptured hemorrhagic cyst, ovarian torsion and even a heterotrophic pregnancy as there had been a few documented cases in the department. Ultrasound diagnosis of an intrauterine pregnancy together with a fluid collection does not suggest by any means that the uterus is intact or there is no ectopic pregnancy.

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Womens' labour and birth experiences in Greece: A cross-sectional study (2022)

Type of publication:Conference abstract

Author(s):Ioannidou M.; Antonakou A.; *Papoutsis D.

Citation:BJOG: An International Journal of Obstetrics and Gynaecology. Conference: Royal College of Obstetricians and Gynaecologists World Congress, RCOG 2022. London United Kingdom. 129(Supplement 1) (pp 220-221), 2022. Date of Publication: June 2022.

Abstract:Objective: We aimed to investigate womens' emotional status, labour and childbirth data, pain relief methods, satisfaction from the midwifery-obstetric team, and the nutrition methods of newborns in Greece. Design(s): We used a modified version of the validated Early Labour and Experience Questionnaire (ELEQ) to capture the experiences of women and events during their labour and childbirth. Method(s): The questionnaire consisted of 64 items and was posted online through the social media between March to May 2021. All women who had given birth were eligible for the study. Upon closure of the study period, statistical analysis was applied to the collected data. Result(s): A total of 3.127 participants responded to the online questionnaire. Increased intervention rates were recorded with 41.1% of participants having an induction of labour, 58.7% having an epidural analgesia and 33.5% a cesarean section. Only 37.6% of respondents reported a spontaneous onset of labor with no interventions at all and a normal vaginal birth. 42.8% of women reported attending prenatal classes, with these women experiencing higher rates of normal vaginal birth. Higher rates of breastfeeding were observed when women had attended prenatal classes and when their vaginal birth had a spontaneous onset of labor. Women who gave birth at home or in a private maternity hospital were more satisfied when compared to women delivering in public hospitals. Women who had a spontaneous vaginal birth had more positive emotions and greater satisfaction levels from their midwife and obstetrician when compared to an induced vaginal birth or a cesarean section. Conclusion(s): Women in Greece experience high rates of interventions during labour and childbirth, which seems to negatively affect their emotional state. Prenatal classes are important as they are correlated with higher rates of normal deliveries and exclusive breastfeeding. Further research is needed to identify the factors that affect womens' experiences during labour and childbirth within the Greek maternity healthcare system in order to improve and shape the current midwifery-obstetric care policy.

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High-fidelity simulation on shoulder dystocia management in Greek Midwives: the SAFE study (2022)

Type of publication:
Conference abstract

Author(s):
*Papoutsis D.; Klazoglou P.; Valasoulis G.

Citation:
BJOG: An International Journal of Obstetrics and Gynaecology. Conference: Royal College of Obstetricians and Gynaecologists World Congress, RCOG 2022. London United Kingdom. 129(Supplement 1) (pp 128), 2022. Date of Publication: June 2022.

Abstract:
Objective: The SAFE study is funded from the Hellenic Foundation for Research and Innovation and its primary objective is to explore and quantify how the knowledge and skills on shoulder dystocia management of Greek Midwives may improve following high-fidelity simulation. Design(s): A high-fidelity simulator that consisted of a pelvic model and a computerised neonatal mannequin with a built in force-monitoring system was utilised for the purposes of shoulder dystocia management in a one-day workshop. Registered midwives were invited to participate in groups of five in a 90-min training session during the workshop. Method(s): The training session consisted of a 30-minute initial assessment, a 30-minute theoretical and hands-on training from the instructor, and a 30-minute final assessment of participants. The outcomes measured involved the performance of maneuvers, the force applied on the neonatal head, the level of communication skills and self-reported confidence. These outcomes were recorded at the start and end of the training session. The checklist of performance involved 20 items in accordance with the RCOG guideline on shoulder dystocia. The force applied on the neonatal head was recorded with the force-monitoring system of the simulator. The communication skills and the self reported confidence of participants were measured on a numerical scale. The pre-and after-training scores of all four outcomes were compared and statistical analysis was applied. Result(s): There were n = 6 one-day workshops with 81 midwives participating in total (October-November 2021). Their mean age was 30.6 +/- 11.1 years old (median:25 years). Prior to training, only 6/81 (7.4%) managed to successfully deliver the impacted shoulder (defined as successful delivery of the posterior arm), with this increasing to 77/81 (95%) after training. The force applied to the neonatal head was similar pre-and after-training (pre:102.20 +/- 38.1 Newtons vs after: 102.13 +/- 27.7 Newtons), with a convergence of the outliers to the mean value. Performance scores (scale:0- 20) improved significantly almost three-fold (pre:5.75 +/- 3.8 vs after:15.63 +/- 2.5), and the self-reported confidence of participants (scale:0-10) increased almost two-fold (pre:3.2 +/- 1.9 vs after: 7.8 +/- 1.4). The communication skills of the participants (scale:0-5) also improved (pre: 2.90 +/- 1.1 vs after: 4.78 +/- 0.5). Those with the most improvement in their confidence were the participants with less clinical experience (r = ?0.329, p = 0.03). Conclusion(s): High-fidelity simulation on the management of shoulder dystocia at childbirth, even after a single training session, can significantly improve the performance score of maneuvers, the levels of confidence and the communication skills of Midwives.

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Factors affecting womens' sexual function during the first-year after childbirth in Greece (2022)

Type of publication:Conference abstract

Author(s):Haritopoulou E.; Papatheodorou D.; Nitsa E.; Antonakou A.; *Papoutsis D.

Citation:BJOG: An International Journal of Obstetrics and Gynaecology. Conference: Royal College of Obstetricians and Gynaecologists World Congress, RCOG 2022. London United Kingdom. 129(Supplement 1) (pp 204), 2022. Date of Publication: June 2022.

Abstract:Objective: Sexual dysfunction after childbirth has been related to the number of vaginal births, the mode of delivery, and to the severity of perineal trauma. The present cross-sectional study was designed to identify the factors that affect the quality of sexual function during the first year after delivery in Greek women. <Design(s): We constructed an 81-item questionnaire that was posted online via the social media for the time period of February-April 2021. Women residing in Greece who had delivered more than 4 weeks ago but not more than 12 months ago were considered eligible for the study. Method(s): Data that was collected included patients' demographics, and data regarding their labour and childbirth. Information on their sexual life before, during and after pregnancy was also collected and the Female Sexual Function Index (FSFI) was used to quantify the sexual function of women during the 4 weeks prior to answering the questionnaire (score range:0-36, with a score of 26 or less indicating sexual dysfunction). After data collection was completed statistical analysis was applied. Result(s): In total there were 441 women responding to the questionnaire with a mean age of 32.5+/-4.4 years old. Approximately half of women delivered 6 months ago and 55.2% were first time mothers. The caesarean section rate in the total sample was 47.9%, and only 34.2% had a spontaneous onset vaginal birth. At childbirth, more than 85% of women sustained perineal trauma, of which 39.3% had an episiotomy. During pregnancy 76% of women had sexual intercourse with their partners, with half of them having a frequency of 2-3 times a month. The mean score of the FSFI index in the total sample was 21.8 +/- 10.7. There was a significant correlation of sexual dysfunction postpartum with exclusive breastfeeding, with increasing maternal age, with reduced number of sleeping hours, with the limited support from their family environment, and with the presence of incontinence. Conversely, the increased frequency of sexual intercourse before and during pregnancy was correlated with a higher score of sexual function postpartum. Perineal trauma, a high body mass index, smoking, and the mode of delivery did not seem to affect the sexual function after delivery. Conclusion(s): We have identified factors that seem to modify the sexual function of Greek women postpartum. These factors should be taken in consideration when providing midwifery care to women after birth.

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Exploring pregnant women's experiences of stopping smoking with an incentive scheme with 'enhanced' support: a qualitative study (2022)

Type of publication:Journal article

Author(s):McCormack F.C.; Hopley R.C.; Boath E.H.; Parry S.L.; Roscoe S.M.; Stewart A.; *Birch V.A.

Citation:Perspectives in Public Health. 2022. [epub ahead of print]

Abstract:Aim: This study aims to understand pregnant women's experiences of smoking cessation with an incentive scheme in a deprived UK city. This is important because smoking cessation with pregnant women is one of the most crucial public health initiatives to promote, and is particularly challenging in deprived areas. While financial incentive schemes are controversial, there is a need to better understand pregnant women's experiences. The scheme combined quasi-financial incentives (shopping vouchers) for validated quits (carbon monoxide (CO) validated at < 10 ppm), enhanced support from smoking cessation advisors, the opportunity to identify a 'Significant Other Supporter' and nicotine replacement therapy. Method(s): With the focus on understanding pregnant women's experiences, a qualitative design was adopted. Semi-structured interviews were completed with 12 pregnant women from the scheme, and the three advisors. All interviews were transcribed, and thematic analysis conducted. Result(s): Pregnant women reported various challenges to quitting, including long-established routines, and stress. Participants were aware of stigma around incentives but were all very positive about the scheme. The relationship with advisors was described as fundamental. The women valued their advice and support, while uptake of the 'Significant Other Supporter' appeared low. Participants viewed the CO monitoring as 'an incentive', while the vouchers were framed as a 'bonus'. Advisors perceived the vouchers as helping engage pregnant women and maintain quit status, and women appreciated the vouchers both as financial assistance and recognition of their accomplishments. Conclusion(s): This study highlights the great value women placed on the support, advice and monitoring from specialist advisors. The distinction between vouchers as a welcomed bonus, rather than 'the incentive' to engage, is important. How smoking cessation and schemes to promote this are communicated to pregnant women and health professionals is important, particularly given the stigma and controversy involved.

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Worth the paper it's written on? A cross-sectional study of Medical Certificate of Stillbirth accuracy in the UK (2022)

Type of publication:Journal article

Author(s):Rimmer MP; Henderson I; *Parry-Smith W; Raglan O; Tamblyn J; Heazell AEP; Higgins LE; UKARCOG NESTT working group authors

Citation:International Journal of Epidemiology, June 2022 [epub ahead of print]

Abstract:Background: The Medical Certificate of Stillbirth (MCS) records data about a baby's death after 24 weeks of gestation but before birth. Major errors that could alter interpretation of the MCS were widespread in two UK-based regional studies. Methods: A multicentre evaluation was conducted, examining MCS issued 1 January 2018 to 31 December 2018 in 76 UK obstetric units. A systematic case-note review of stillbirths was conducted by Obstetric and Gynaecology trainees, generating individual 'ideal MCSs' and comparing these to the actual MCS issued. Anonymized central data analysis described rates and types of error, agreement and factors associated with major errors. Results: There were 1120 MCSs suitable for assessment, with 126 additional submitted data sets unsuitable for accuracy analysis (total 1246 cases). Gestational age demonstrated 'substantial' agreement [K = 0.73 (95% CI 0.70-0.76)]. Primary cause of death (COD) showed 'fair' agreement [K = 0.26 (95% CI 0.24-0.29)]. Major errors [696/1120; 62.1% (95% CI 59.3-64.9%)] included certificates issued for fetal demise at <24 weeks' gestation [23/696; 3.3% (95% CI 2.2-4.9%)] or neonatal death [2/696; 0.3% (95% CI 0.1-1.1%)] or incorrect primary COD [667/696; 95.8% (95% CI 94.1-97.1%)]. Of 540/1246 [43.3% (95% CI 40.6-46.1%)] 'unexplained' stillbirths, only 119/540 [22.0% (95% CI 18.8-25.7%)] remained unexplained; the majority were redesignated as either fetal growth restriction [FGR: 195/540; 36.1% (95% CI 32.2-40.3%)] or placental insufficiency [184/540; 34.1% (95% CI 30.2-38.2)]. Overall, FGR [306/1246; 24.6% (95% CI 22.3-27.0%)] was the leading primary COD after review, yet only 53/306 [17.3% (95% CI 13.5-22.1%)] FGR cases were originally attributed correctly. Conclusion: This study demonstrates widespread major errors in MCS completion across the UK. MCS should only be completed following structured case-note review, with particular attention on the fetal growth trajectory.

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Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: The MifeMiso RCT (2021)

Type of publication:Journal article

Author(s):Devall A.; Chu J.; Gallos I.; Coomarasamy A.; Beeson L.; Cheed V.; Sun Y.; Roberts T.; Ogwulu C.O.; Williams E.; Jones L.; La Fontaine Papadopoulos J.; Hardy P.; Bender-Atik R.; Brewin J.; Hinshaw K.; Ahmed A.; Choudhary M.; Naftalin J.; Nunes N.; Oliver A.; Izzat F.; Bhatia K.; Hassan I.; Jeve Y.; Hamilton J.; Deb S.; Bottomley C.; Ross J.; Watkins L.; *Underwood M.; Cheong Y.; Kumar C.; Gupta P.; Small R.; Pringle S.; Hodge F.; Shahid A.; Horne A.; Quenby S.

Citation:Health Technology Assessment; 2021; vol. 25 (no. 68), p. 1-114

Abstract:Background Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in a miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Management of miscarriage can be expectant (i.e. waiting for natural miscarriage), medical (i.e. with drugs) or surgical. About 25% of women opt for medical management; however, there is uncertainty about the optimal drug regimens for medical management. Before National Institute for Health and Care Excellence (NICE) guideline CG154 was published in 2012, it was common practice to use a combination of mifepristone (Mifegyne, Exelgyn, Paris, France) and misoprostol. The 2012 guideline, however, recommended that misoprostol alone should be given to women having medical management. This recommendation was based on very limited evidence, from one study of 115 women, which found no difference between a combination of mifepristone and misoprostol and misoprostol alone. Recognising the limited available evidence, NICE and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) called for a trial. Objectives The primary objective was to test the hypothesis that treatment with mifepristone plus misoprostol is superior to treatment with misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed by pelvic ultrasound scan with a missed miscarriage in the first 14 weeks of pregnancy. The key secondary objective aimed to test the hypothesis that the addition of mifepristone reduces the need for surgical intervention to resolve the miscarriage. Other secondary objectives aimed to evaluate if the addition of mifepristone reduces the need for further doses of misoprostol, to evaluate if the addition of mifepristone improves other clinical outcomes [including surgical intervention up to and including 7 days post randomisation and after 7 days post randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post randomisation, time from randomisation to discharge from early pregnancy unit (EPU) care, side effects and complications], to evaluate if the addition of mifepristone improves patient satisfaction and acceptability of management and to assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage. Methods Participants were randomised online in a 1: 1 ratio via a secure internet facility through an Integrated Trial Management System. Minimisation was implemented for maternal age (< 30 or >= 30 years), body mass index (< 35 or >= 35 kg/m2), previous parity (nulliparous or parous women), gestational age (< 70 or >= 70 days), amount of bleeding (Pictorial Blood loss Assessment Chart score; <= 2 or >= 3) and randomising centre. Clinical data were collected up to discharge from EPU care. Participants who agreed to participate in the qualitative study were interviewed by telephone or videoconference or face to face within approximately 6 weeks of their discharge date. The primary analysis was by intention to treat. A withintrial cost-effectiveness study and a nested qualitative study were also conducted as part of the trial. Results A total of 711 women, from 28 hospitals in the UK, received either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group [risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 0.98; p = 0.04]. Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (RR 0.70, 95% CI 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview.Women appeared to have a preference for active management of their miscarriage, to help bring a timely resolution to the physical process. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The within-trial cost-effectiveness analysis found that the use of mifepristone and misoprostol resulted in an absolute effect difference of 6.6% (95% CI 0.7% to 12.5%). The average cost per woman was lower in the mifepristone and misoprostol (MifeMiso) group than in the placebo and misoprostol group, with a cost saving of 182 (95% CI 26 to 338). Hence the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. The modelbased analysis, that compared the trial intervention with other existing possible interventions for the management of miscarriage not analysed in the trial, showed that the MifeMiso intervention is dominant when compared with expectant management and the current medical management strategy. However, the intervention is a less effective, although less costly, strategy than surgical management. Conclusions Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again.

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