Admission ultrasonography as a means of identifying unrecognized fetal compromise in term singleton pregnancies at the onset of labor - a feasibility study.

OBJECTIVES: Apparently uncomplicated low-risk pregnancies, especially first time births, account for a significant proportion of adverse birth outcomes. Improved risk stratification with a simple bedside scan on admission in early labor could potentially reduce adverse intrapartum outcomes. The aim of this feasibility study was to assess a cohort of low-risk subjects with admission ultrasonography at the onset of labor with a view to conducting a future randomized controlled trial (RCT). The objectives were three-fold; i) to determine the logistics of performing a labor admission ultrasound scan ii) to establish whether abnormal ultrasound features can be identified and iii) whether they are associated with emergency delivery and/or poor condition of the neonate at birth. METHODS: We performed a prospective cohort study of 295 participants with term singleton cephalic pregnancies admitted in early labor or for labor induction with non-fetal indications. The setting was a university teaching hospital in Ireland with almost 8000 births annually. A bedside ultrasound scan was performed to assess fetal biometry, amniotic fluid volume and placental maturity. Patients and their babies were followed up until hospital discharge. The outcomes of interest included image quality, time to perform a scan, oligohydramnios (Single Deepest Pool ≤ 2 cm), small for gestational age (SGA; abdominal circumference <10th centile), mature placenta (Grannum 2 or 3), pathological CTG, emergency cesarean section (CS), fetal acidosis (cord arterial pH <7.10 or base excess <-12.0), low Apgar score <7 at 5 min and neonatal unit admission. RESULTS: Image quality was optimal in 274 of the 295 scans (93%) and 271 (92%) were completed in less than 10 min. Of this low-risk population, 67 of 294 (23%) had oligohydramnios, 11 (4%) were small for gestational age and 87 (30%) had a mature placenta (Grannum grade 2). The incidence of pathological CTG and emergency CS was higher among patients with oligohydramnios than those with a normal scan but did not reach statistical significance; Odds Ratio 3.40 (95% Confidence Intervals 0.55 to 20.92) and OR 1.43 (95% CI 0.66 to 3.08) respectively. The mean birthweight was significantly lower in those with oligohydramnios -139 g (95% CI -248 to -30) and admission scan detected SGA -357 g (95% CI -557 to -137). Adverse perinatal outcomes were uncommon with a higher incidence of fetal acidosis (pH < 7.10) in the oligohydramnios group. The incidence of neonatal unit admission >24 h was higher in the oligohydramnios group but not statistically significant; OR 3.75 (95% CI 0.61 to 22.97). Results for SGA alone were non-significant and results for oligohydramnios and SGA combined were similar to those for oligohydramnios alone. CONCLUSIONS: Admission ultrasonography is feasible in a routine clinical setting, but evidence of benefit is weak and does not currently justify a randomized controlled trial.

Fetal scalp stimulation for assessing fetal well-being during labour.

BACKGROUND: Continuous fetal heart rate monitoring by cardiotocography (CTG) is used in labour for women with complicated pregnancies. Fetal heart rate abnormalities are common and may result in the decision to expedite delivery by caesarean section. Fetal scalp stimulation (FSS) is a second-line test of fetal well-being that may provide reassurance that the labour can continue. OBJECTIVES: To evaluate methods of FSS as second-line tests of intrapartum fetal well-being in cases of non-reassuring CTG. FSS and CTG were compared to CTG alone, and to CTG with fetal blood sampling (FBS). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, the WHO ICTRP and conference proceedings), ClinicalTrials.gov (18 October 2022), and reference lists of retrieved studies. SELECTION CRITERIA: Eligible studies were randomised controlled trials (RCTs) that compared any form of FSS to assess fetal well-being in labour. Quasi-RCTs, cluster-RCTs and studies published in abstract form were also eligible for inclusion, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: Two trials, involving 377 women, met the inclusion criteria for this review. Both trials were conducted in hospital settings and included women with singleton, term (37+0 weeks or more) pregnancies, a cephalic presentation, and abnormal CTG. Follow-up was until hospital discharge after the birth. A pilot trial of 50 women in a high-income country (Ireland) compared CTG and digital fetal scalp stimulation (dFSS) with CTG and fetal blood sampling (FBS). A single-centre trial of 327 women in a lower middle-income country (India) compared CTG and manual fetal stimulation (abdominal or vaginal scalp stimulation) with CTG alone. The two included studies were at moderate or unclear risk of bias. Both trials provided clear information on allocation concealment but it was not possible to blind participants or health professionals in relation to the intervention. Although objective outcome measures were reported, outcome assessment was not blinded or blinding was unclear. dFSS and CTG versus FBS and CTG There were no perinatal deaths and data were not reported for neurodevelopmental disability at >/= 12 months. The risk of caesarean section (CS) may be lower with dFSS compared to FBS (risk ratio (RR) 0.38, 95% confidence interval (CI) 0.16 to 0.92; 1 pilot trial, 50 women; very low-certainty evidence) but the evidence is very uncertain. There were no cases of neonatal encephalopathy reported. The evidence was also very uncertain between dFSS and FBS for assisted vaginal birth (RR 1.44, 95% CI 0.76 to 2.75; very low-certainty evidence) and for the spontaneous vaginal birth rate (RR 2.33, 95% CI 0.68 to 8.01, very low-certainty evidence). Maternal acceptability of the procedures was not reported. FSS and CTG versus CTG alone Manual stimulation of the fetus was performed either abdominally (92/164) or vaginally (72/164). There were no perinatal deaths and data were not reported for neurodevelopmental disability at >/= 12 months. There may be little differences in the risk of CS on comparing manual fetal stimulation and CTG with CTG alone (RR 0.83, 95% CI 0.59 to 1.18; 1 trial, 327 women; very low-certainty evidence), but again the evidence was very uncertain. There were no cases of neonatal encephalopathy reported. There may be no differences in the risk of assisted vaginal birth (RR 1.43, 95% CI 0.78 to 2.60; very low-certainty evidence) or in the rates of spontaneous vaginal birth (RR 1.01, 95% CI 0.85 to 1.21, very low-certainty evidence), but again the evidence is very uncertain. Maternal acceptability of abdominal stimulation/FSS was not reported although 13 women withdrew consent after randomisation due to concerns about fetal well-being. AUTHORS' CONCLUSIONS: There is very low-certainty evidence available which makes it unclear whether stimulating the fetal scalp is a safe and effective way to confirm fetal well-being in labour. Evidence was downgraded based on limitations in study design and imprecision. Further high-quality studies of adequate sample size are required to evaluate this research question. In order to be generalisable, these trials should be conducted in different settings, including broad clinical criteria at both preterm and term gestational ages, and standardising the method of stimulation. There is an ongoing study (FIRSST) that will be incorporated into this review in a subsequent update.

Cervical ripening and labour induction: A critical review of the available methods.

Induction of labour is one of the most common interventions experienced by pregnant women. There are two overlapping components to labour induction, which include cervical ripening and the initiation of regular contractions. A large number of clinical studies have been conducted for evaluating the methods used for induction of labour, their effectiveness and safety, and pregnancy outcomes. Randomised controlled trials (RCTs) provide the strongest form of evidence for clinical practice. These data are brought together in systematic reviews and have been incorporated into national and international guidelines. Despite this, there is considerable variation in the recommendations between guidelines. Heterogeneity between studies, inconsistency in the definitions of trial outcomes, and underpowered sample size contribute to the difficulty in making robust recommendations. There are pharmacological and non-pharmacological approaches that can be compared with each other and with placebo or no treatment. There are also complementary therapies that may appeal to women but lack evidence of their effectiveness. These issues have been addressed in the current chapter, with a critical review of the research evidence presented in clinical trials and systematic reviews.

Prospective cohort study of water immersion for labour and birth compared with standard care in an Irish maternity setting.

OBJECTIVE: To examine the birth outcomes for women and babies following water immersion for labour only, or for labour and birth. DESIGN: Prospective cohort study. SETTING: Maternity hospital, Ireland, 2016-2019. PARTICIPANTS: A cohort of 190 low-risk women who used water immersion; 100 gave birth in water and 90 laboured only in water. A control group of 190 low-risk women who received standard care. METHODS: Logistic regression analyses examined associations between water immersion and birth outcomes adjusting for confounders. A validated Childbirth Experience Questionnaire was completed. MAIN OUTCOME MEASURES: Perineal tears, obstetric anal sphincter injuries (OASI), postpartum haemorrhage (PPH), neonatal unit admissions (NNU), breastfeeding and birth experiences. RESULTS: Compared with standard care, women who chose water immersion had no significant difference in perineal tears (71.4% vs 71.4%, adj OR 0.83; 95% CI 0.49 to 1.39) or in OASI (3.3% vs 3.8%, adj OR 0.91; 0.26-2.97). Women who chose water immersion were more likely to have a PPH ≥500 mL (10.5% vs 3.7%, adj OR 2.60; 95% CI 1.03 to 6.57), and to exclusively breastfeed at discharge (71.1% vs 45.8%, adj OR 2.59; 95% CI 1.66 to 4.05). There was no significant difference in NNU admissions (3.7% vs 3.2%, adj OR 1.06; 95% CI 0.33 to 3.42). Women who gave birth in water were no more likely than women who used water for labour only to require perineal suturing (64% vs 80.5%, adj OR 0.63; 95% CI 0.30 to 1.33), to experience OASI (3.0% vs 3.7%, adj OR 1.41; 95% CI 0.23 to 8.79) or PPH (8.0% vs 13.3%, adj OR 0.73; 95% CI 0.26 to 2.09). Women using water immersion reported more positive memories than women receiving standard care (p<0.01). CONCLUSIONS: Women choosing water immersion for labour or birth were no more likely to experience adverse birth outcomes than women receiving standard care and rated their birth experiences more highly.

Membrane sweeping for induction of labour.

BACKGROUND: Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical methods used to induce labour. Membrane sweeping is a mechanical technique whereby a clinician inserts one or two fingers into the cervix and using a continuous circular sweeping motion detaches the inferior pole of the membranes from the lower uterine segment. This produces hormones that encourage effacement and dilatation potentially promoting labour. This review is an update to a review first published in 2005. OBJECTIVES: To assess the effects and safety of membrane sweeping for induction of labour in women at or near term (≥ 36 weeks' gestation). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (25 February 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 February 2019), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed on a predefined list of labour induction methods. Cluster-randomised trials were eligible, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, risk of bias and extracted data. Data were checked for accuracy. Disagreements were resolved by discussion, or by including a third review author. The certainty of the evidence was assessed using the GRADE approach. MAIN RESULTS: We included 44 studies (20 new to this update), reporting data for 6940 women and their infants. We used random-effects throughout. Overall, the risk of bias was assessed as low or unclear risk in most domains across studies. Evidence certainty, assessed using GRADE, was found to be generally low, mainly due to study design, inconsistency and imprecision. Six studies (n = 1284) compared membrane sweeping with more than one intervention and were thus included in more than one comparison. No trials reported on the outcomes uterine hyperstimulation with/without fetal heart rate (FHR) change, uterine rupture or neonatal encephalopathy. Forty studies (6548 participants) compared membrane sweeping with no treatment/sham Women randomised to membrane sweeping may be more likely to experience: · spontaneous onset of labour (average risk ratio (aRR) 1.21, 95% confidence interval (CI) 1.08 to 1.34, 17 studies, 3170 participants, low-certainty evidence). but less likely to experience: · induction (aRR 0.73, 95% CI 0.56 to 0.94, 16 studies, 3224 participants, low-certainty evidence); There may be little to no difference between groups for: · caesareans (aRR 0.94, 95% CI 0.85 to 1.04, 32 studies, 5499 participants, moderate-certainty evidence); · spontaneous vaginal birth (aRR 1.03, 95% CI 0.99 to 1.07, 26 studies, 4538 participants, moderate-certainty evidence); · maternal death or serious morbidity (aRR 0.83, 95% CI 0.57 to 1.20, 17 studies, 2749 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.83, 95% CI 0.59 to 1.17, 18 studies, 3696 participants, low-certainty evidence). Four studies reported data for 480 women comparing membrane sweeping with vaginal/intracervical prostaglandins There may be little to no difference between groups for the outcomes: · spontaneous onset of labour (aRR, 1.24, 95% CI 0.98 to 1.57, 3 studies, 339 participants, low-certainty evidence); · induction (aRR 0.90, 95% CI 0.56 to 1.45, 2 studies, 157 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.44 to 1.09, 3 studies, 339 participants, low-certainty evidence); · spontaneous vaginal birth (aRR 1.12, 95% CI 0.95 to 1.32, 2 studies, 252 participants, low-certainty evidence); · maternal death or serious morbidity (aRR 0.93, 95% CI 0.27 to 3.21, 1 study, 87 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.40, 95% CI 0.12 to 1.33, 2 studies, 269 participants, low-certainty evidence). One study, reported data for 104 women, comparing membrane sweeping with intravenous oxytocin +/- amniotomy There may be little to no difference between groups for: · spontaneous onset of labour (aRR 1.32, 95% CI 88 to 1.96, 1 study, 69 participants, low-certainty evidence); · induction (aRR 0.51, 95% CI 0.05 to 5.42, 1 study, 69 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.12 to 3.85, 1 study, 69 participants, low-certainty evidence); · maternal death or serious morbidity was reported on, but there were no events. Two studies providing data for 160 women compared membrane sweeping with vaginal/oral misoprostol There may be little to no difference between groups for: · caesareans (RR 0.82, 95% CI 0.31 to 2.17, 1 study, 96 participants, low-certainty evidence). One study providing data for 355 women which compared once weekly membrane sweep with twice-weekly membrane sweep and a sham procedure There may be little to no difference between groups for: · induction (RR 1.19, 95% CI 0.76 to 1.85, 1 study, 234 participants, low-certainty); · caesareans (RR 0.93, 95% CI 0.60 to 1.46, 1 study, 234 participants, low-certainty evidence); · spontaneous vaginal birth (RR 1.00, 95% CI 0.86 to 1.17, 1 study, 234 participants, moderate-certainty evidence); · maternal death or serious maternal morbidity (RR 0.78, 95% CI 0.30 to 2.02, 1 study, 234 participants, low-certainty evidence); · neonatal death or serious neonatal perinatal morbidity (RR 2.00, 95% CI 0.18 to 21.76, 1 study, 234 participants, low-certainty evidence); We found no studies that compared membrane sweeping with amniotomy only or mechanical methods. Three studies, providing data for 675 women, reported that women indicated favourably on their experience of membrane sweeping with one study reporting that 88% (n = 312) of women questioned in the postnatal period would choose membrane sweeping in the next pregnancy. Two studies reporting data for 290 women reported that membrane sweeping is more cost-effective than using prostaglandins, although more research should be undertaken in this area. AUTHORS' CONCLUSIONS: Membrane sweeping may be effective in achieving a spontaneous onset of labour, but the evidence for this was of low certainty. When compared to expectant management, it potentially reduces the incidence of formal induction of labour. Questions remain as to whether there is an optimal number of membrane sweeps and timings and gestation of these to facilitate induction of labour.

Forceps delivery for non-rotational and rotational operative vaginal delivery.

Forceps are a commonly used instrument for assisting vaginal birth. Accepted indications include prolonged labour, suspected foetal distress and maternal medical conditions that benefit from a shortened second stage of labour. Maternal and offspring outcomes of forceps-assisted birth have been extensively reported in observational studies, but randomised trial evidence is limited. Forceps-assisted delivery has a lower failure rate than vacuum-assisted delivery but is associated with a higher incidence of maternal pelvic floor trauma. Second-stage caesarean section is associated with less foetal-neonatal trauma than forceps-assisted delivery but markedly reduces the chance of a subsequent vaginal birth. This review outlines the existing evidence on prevention, indications and contraindications for forceps-assisted birth (non-rotational and rotational), short- and long-term complications for mother and baby, alternatives to use of forceps and how to manage an abandoned forceps-assisted birth. The essential components of informed consent are also discussed.

Medico-legal considerations and operative vaginal delivery.

Women undergo operative vaginal delivery (OVD) as an alternative to caesarean section when complications arise in the second stage of labour. The perinatal mortality associated with OVD is very low, and most of the perinatal morbidity is minor. However, when serious adverse events occur, such as traumatic birth injury, shoulder dystocia, cerebral palsy and perinatal death, there are medico-legal implications. There is also the potential for litigation in relation to maternal pelvic floor injury, which is increased with OVD. Obstetricians performing and supervising OVDs need to be aware of the potential pitfalls and minimise the risk of adverse outcomes. Given that most obstetricians will be involved in adverse birth-related events, it is important that they are aware of the legal processes that may ensue. It is also important when reviewing adverse OVD-related outcomes that association is differentiated from causation. These issues are addressed in the current chapter with attention drawn to the Montgomery ruling, which redefines the legal standards expected in relation to informed consent.

PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol.

INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies. METHODS AND ANALYSIS: This is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks' gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care. ETHICS AND DISSEMINATION: Ethical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02881073.

Intramuscular versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery: randomised controlled trial.

OBJECTIVE: To determine whether intravenous oxytocin is more effective than intramuscular oxytocin at preventing postpartum haemorrhage at vaginal delivery. DESIGN: Double blind placebo controlled randomised trial. SETTING: University affiliated maternity unit in the Republic of Ireland. PARTICIPANTS: 1075 women aged 18 years or older, at term with a singleton pregnancy who were aiming for a vaginal delivery with an actively managed third stage of labour. INTERVENTIONS: Women were allocated to an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over one minute) and placebo intramuscular injection (1 mL 0.9% saline) or an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly over one minute) at vaginal delivery. Allocation was by a secure web based randomisation service with masking of participants and clinicians to the trial intervention. MAIN OUTCOME MEASURES: The primary outcome was postpartum haemorrhage (PPH, measured blood loss ≥500 mL). Secondary outcomes were severe PPH (measured blood loss ≥1000 mL), need for blood transfusion, admission to a high dependency unit, and side effects to oxytocin. RESULTS: Between 4 January 2016 and 13 December 2017, 1075 women were randomised and 1035 (96.3%) included in the primary and secondary analyses (517 in the intravenous oxytocin group and 518 in the intramuscular oxytocin group). The incidence of PPH was not significantly lower in the intravenous group (18.8%, 97/517) compared with intramuscular group (23.2%, 120/518): adjusted odds ratio 0.75 (95% confidence interval 0.55 to 1.03). The incidence of severe PPH, however, was significantly lower in the intravenous group (4.6%, 24/517) compared with intramuscular group (8.1%, 42/518): 0.54 (0.32 to 0.91) as was the need for blood transfusion (1.5% v 4.4%, 0.31, 0.13 to 0.70) and admission to a high dependency unit (1.7% v 3.7%, 0.44, 0.20 to 0.98). The number needed to treat to prevent one case of severe PPH was 29 (95% confidence interval 16 to 201) and to prevent one case of blood transfusion was 35 (20 to 121). The incidence of side effects to oxytocin was not increased in the intravenous group compared with intramuscular group (4.1% v 5.2%, 0.75, 0.42 to 1.35). CONCLUSION: Intravenous oxytocin for the third stage of labour results in less frequent severe PPH, blood transfusion, and admission to a high dependency unit than intramuscular oxytocin, and without excess side effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14718882.

Fetal scalp stimulation (FSS) versus fetal blood sampling (FBS) for women with abnormal fetal heart rate monitoring in labor: a prospective cohort study.

OBJECTIVE: To evaluate the performance of fetal scalp stimulation (FSS) compared to fetal blood sampling (FBS) as a second line test of fetal wellbeing in labor. STUDY DESIGN: A prospective cohort study was conducted including 298 fetal blood sampling procedures performed due to abnormal fetal cardiotocography (CTG). Two independent observers interpreted the CTG following stimulation. The FSS test was classified as normal when an elicited acceleration and/or provoked fetal heart rate variability was recorded. The FBS was classified as normal (pH ≥7.25), borderline (pH 7.21-7.24), and abnormal (pH ≤7.20). RESULTS: Of the 298 procedures, 249 (84%) had a normal scalp pH result, 199 (67%) had an acceleration in response to FSS and 255 (86%) had an acceleration or normal variability in response to FSS. All 11 of the neonates classified as normal by FSS, but abnormal by FBS were born with normal Apgar scores and cord pH results. The consistency between FSS and FBS was "fair" (kappa 0.28) while the consistency between either test and cord arterial pH was "poor". CONCLUSIONS: This study suggests that FSS has the potential to be a reliable alternative to FBS. The findings require evaluation in a well-designed randomized controlled trial.

Ustekinumab Drug Levels in Maternal and Cord Blood in a Woman With Crohn's Disease Treated Until 33 Weeks of Gestation.

A 35-year old woman with ileocolonic, perianal, and vulval Crohn's disease was treated with subcutaneous ustekinuamb [USK] throughout pregnancy. Dose intervals were shortened from 6-weekly to 4-weekly to maintain clinical remission. The last dose of USK was administered at 33 weeks of gestation, and a healthy baby boy was delivered by caesarean section at 37 weeks. Maternal trough USK levels remained stable during pregnancy. Cord blood USK levels were nearly 2-fold higher than contemporaneous maternal serum levels. To our knowledge, this is the first report of maternal and cord USK levels in a patient with Crohn's disease.

Intramuscular oxytocin versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery (LabOR trial): study protocol for a randomised controlled trial.

BACKGROUND: Primary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in developed countries despite routine active management of the third stage of labour. In less-developed countries, primary PPH remains the leading cause of maternal death. Although the value of routine oxytocics in the third stage of labour has been well established, there is inconsistent practice in the choice of agent and route of administration. Oxytocin is the preferred agent because it has fewer side effects than other uterotonics with similar efficacy. It can be given intravenously or intramuscularly; however, to date, the most effective route of administering oxytocin has not been established. METHODS/DESIGN: A double-blind randomised controlled trial is planned. The aim of the study is to compare the effects of an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly) with an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over 1 min) and placebo intramuscular injection (1 mL 0.9% saline) at vaginal delivery. The study will recruit 1000 women at term (>36 weeks) with singleton pregnancies who are aiming for a vaginal delivery. The primary outcome will be PPH (measured blood loss ≥ 500 mL). A study involving 1000 women will have 80% power at the 5% two-sided alpha level, to detect differences in the proportion of patients with measured blood loss > 500 ml of 10% vs 5%. DISCUSSION: Given the increasing trends of atonic PPH it is both important and timely that we evaluate the most effective route of oxytocin administration for the management of the third stage of labour. To date, there has been limited research comparing the efficacy of intramuscular oxytocin vs intravenous oxytocin for the third stage of labour. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN14718882 . Registered on 4 January 2016. Pilot commenced 12.12.2015; trial commenced 04.01.2016. The protocol (Ref 012012) was approved by the National Maternity Hospital Research Ethics Committee on 10.06.2015 and the Research Ethics Committee of the Coombe Women & Infants University Hospital (Ref 26-2015) on 09.12.2015.

Proposed learning strategies of medical students in a clinical rotation in obstetrics and gynecology: a descriptive study.

BACKGROUND: Medical students face many challenges when learning within clinical environments. How students plan to use their time and engage with learning opportunities is therefore critical, as it may be possible to highlight strategies that optimize the learning experience at an early stage in the rotation. The aim of the study was to describe the learning drivers and proposed learning strategies of medical students for a clinical rotation in obstetrics and gynecology. METHODS: A descriptive study of personal learning plans completed by students at the start of their clinical rotation in obstetrics and gynecology was undertaken. Data relating to students' learning strategies were obtained from the personal learning plans completed by students. Quantitative and qualitative analyses were used. RESULTS: The desire to obtain a good examination result was the most significant reason why the rotation was important to students (n=67/71, 94%). Students struggled to create a specific and practical learning outcome relevant to their career interest. Target scores of students were significantly higher than their reported typical scores (P<0.01). Textbooks were rated as likely to be the most helpful learning resource during the rotation. Bedside tutorials were rated as likely to be the most useful learning activity and small group learning activities were rated as likely to be more useful than lectures. Most students intended to study the course material linked to their clinical program rather than the classroom-based tutorial program. CONCLUSION: The main learning driver for medical students was academic achievement, and the proposed learning strategy favored by medical students was linking their study plans to clinical activities. Medical educators should consider strategies that foster more intrinsic drivers of student learning and more student-oriented learning resources and activities.

Student and staff experiences of attendance monitoring in undergraduate obstetrics and gynecology: a cross-sectional survey.

BACKGROUND: Despite the widespread introduction of active learning strategies to engage students across modern medical curricula, student attendance and attendance monitoring remain a challenging issue for medical educators. In addition, there is little published evidence available to medical educators regarding the use of attendance monitoring systems. The aim of this study was to evaluate the opinions of students and staff about the use of a paper-based student logbook to record student attendance across all clinical and classroom-based learning activities within an undergraduate clinical rotation in obstetrics and gynecology (OBGYN). METHODS: Each student undertaking the clinical rotation in OBGYN was required to complete a paper-based logbook in a booklet format that listed every clinical and classroom-based activity that the student was expected to attend. A cross-sectional survey evaluating the acceptability, practicality, and effect on access to learning opportunities of using the logbook was undertaken. The survey was conducted among all medical students who completed their OBGYN rotation over a full academic year and staff who taught on the program. RESULTS: The response rate was 87% (n=128/147) among students and 80% (n=8/10) among staff. Monitoring attendance was widely acceptable to students (n=107/128, 84%) and staff (n=8/8, 100%). Most students (n=95/128, 74%) and staff (n=7/8, 88%) recommended that attendance should be mandatory during rotations. Almost all staff felt that attendance should contribute toward academic credit (n=7/8, 88%), but students were divided (n=73/128, 57%). Students (n=94/128, 73%) and staff (n=6/8, 75%) reported that the use of the logbook to record attendance with tutor signatures was a satisfactory system, although students questioned the need for recording attendance at every classroom-based activity. Most students felt that the logbook facilitated access to learning experiences during the rotation (n=90/128, 71%). Staff felt that the process of signing logbooks improved their interaction with students (n=6/8, 75%). CONCLUSION: The survey showed that the use of a paper-based logbook to record medical student attendance with tutor signatures across all clinical and classroom-based learning activities was acceptable and practical for students and staff and was felt to facilitate access to learning opportunities. The study provides medical educators with evidence to support monitoring of attendance within clinical rotations.

Team Objective Structured Bedside Assessment (TOSBA) as formative assessment in undergraduate Obstetrics and Gynaecology: a cohort study.

BACKGROUND: Team Objective Structured Bedside Assessment (TOSBA) is a learning approach in which a team of medical students undertake a set of structured clinical tasks with real patients in order to reach a diagnosis and formulate a management plan and receive immediate feedback on their performance from a facilitator. TOSBA was introduced as formative assessment to an 8-week undergraduate teaching programme in Obstetrics and Gynaecology (O&G) in 2013/14. Each student completed 5 TOSBA sessions during the rotation. The aim of the study was to evaluate TOSBA as a teaching method to provide formative assessment for medical students during their clinical rotation. The research questions were: Does TOSBA improve clinical, communication and/or reasoning skills? Does TOSBA provide quality feedback? METHODS: A prospective cohort study was conducted over a full academic year (2013/14). The study used 2 methods to evaluate TOSBA as a teaching method to provide formative assessment: (1) an online survey of TOSBA at the end of the rotation and (2) a comparison of the student performance in TOSBA with their performance in the final summative examination. RESULTS: During the 2013/14 academic year, 157 students completed the O&G programme and the final summative examination . Each student completed the required 5 TOSBA tasks. The response rate to the student survey was 68 % (n = 107/157). Students reported that TOSBA was a beneficial learning experience with a positive impact on clinical, communication and reasoning skills. Students rated the quality of feedback provided by TOSBA as high. Students identified the observation of the performance and feedback of other students within their TOSBA team as key features. High achieving students performed well in both TOSBA and summative assessments. The majority of students who performed poorly in TOSBA subsequently passed the summative assessments (n = 20/21, 95 %). Conversely, the majority of students who failed the summative assessments had satisfactory scores in TOSBA (n = 6/7, 86 %). CONCLUSIONS: TOSBA has a positive impact on the clinical, communication and reasoning skills of medical students through the provision of high-quality feedback. The use of structured pre-defined tasks, the observation of the performance and feedback of other students and the use of real patients are key elements of TOSBA. Avoiding student complacency and providing accurate feedback from TOSBA are on-going challenges.