Local cooling for relieving pain from perineal trauma sustained during childbirth.

BACKGROUND: Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. OBJECTIVES: To evaluate the effectiveness and side effects of localised cooling treatments compared with no treatment, other forms of cooling treatments and non-cooling treatments. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2007), CINAHL (1982 to January 2007) and contacted experts in the field. SELECTION CRITERIA: Published and unpublished randomised and quasi-randomised trials (RCTs) that compared localised cooling treatment applied to the perineum with no treatment or other treatments applied to relieve pain related to perineal trauma sustained during childbirth. DATA COLLECTION AND ANALYSIS: At least two independent authors performed data extraction for each study. Analyses were performed on an intention-to-treat basis where data allowed. We sought additional information from the authors of three trials. MAIN RESULTS: Seven published RCTs were included, comparing local cooling treatments (ice packs, cold gel pads or cold/iced baths) with no treatment, hamamelis water (witch hazel), pulsed electromagnetic energy (PET), hydrocortisone/pramoxine foam [Epifoam] or warm baths. The RCTs reported on a total of 859 women. Ice packs provided improved pain relief 24 to 72 hours after birth compared with no treatment (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.41 to 0.91). Women preferred the utility of the gel pads compared with ice packs or no treatment, although no differences in pain relief were detected between the treatments. None of our comparisons of treatments resulted in differences detected in perineal oedema or bruising. Women reported more pain (RR 5.60, 95% CI 2.35 to 13.33) and used more additional analgesia (RR 4.00, 95% CI 1.44 to 11.13) following the application of ice packs compared with PET. AUTHORS' CONCLUSIONS: There is only limited evidence to support the effectiveness of local cooling treatments (ice packs, cold gel pads, cold/iced baths) applied to the perineum following childbirth to relieve pain.

Fetal pulse oximetry for fetal assessment in labour.

BACKGROUND: Pulse oximetry could contribute to the evaluation of fetal well-being during labour. OBJECTIVES: To compare the effectiveness and safety of fetal pulse oximetry with conventional surveillance techniques. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2006), MEDLINE (1994 to November 2006), EMBASE (1994 to November 2006) and Current Contents (1994 to November 2006). SELECTION CRITERIA: All published and unpublished randomised controlled trials that compared maternal and fetal outcomes when fetal pulse oximetry was used in labour, with or without concurrent use of conventional fetal surveillance, compared with using cardiotocography (CTG) alone. DATA COLLECTION AND ANALYSIS: At least two independent authors performed data extraction. Analyses were performed on an intention-to-treat basis. We sought additional information from the investigators of three of the reported trials. MAIN RESULTS: Five published trials comparing fetal pulse oximetry and CTG with CTG alone (or when fetal pulse oximetry values were blinded) were included. The published trials, with some unpublished data, reported on a total of 7424 pregnancies. Differing entry criteria necessitated separate analyses, rather than meta-analysis of all trials. Four trials reported no significant differences in the overall caesarean section rate between those monitored with fetal oximetry and those not monitored with fetal pulse oximetry or for whom the fetal pulse oximetry results were masked. Neonatal seizures and hypoxic ischemic encephalopathy were rare. No studies reported details of assessment of long-term disability. There was a statistically significant decrease in caesarean section for nonreassuring fetal status in the fetal pulse oximetry plus CTG group compared to the CTG group in two analyses: (i) gestation from 36 weeks with fetal blood sample (fetal blood sampling) not required prior to study entry (relative risk (RR) 0.68, 95% confidence interval (CI) 0.47 to 0.99); and (ii) when fetal blood sampling was required prior to study entry (RR 0.03, 95% CI 0.00 to 0.44). There was no statistically significant difference in caesarean section for dystocia when fetal pulse oximetry (fetal pulse oximetry) was added to CTG monitoring, compared with CTG monitoring alone, although the incidence rates varied between the trials. AUTHORS' CONCLUSIONS: The data provide limited support for the use of fetal pulse oximetry when used in the presence of a nonreassuring CTG, to reduce caesarean section for nonreassuring fetal status. The addition of fetal pulse oximetry does not reduce overall caesarean section rates. A better method to evaluate fetal well-being in labour is required.

A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial).

OBJECTIVE: To report an economic analysis of the Australian intrapartum fetal pulse oximetry (FPO) multicentre randomised controlled trial (the FOREMOST trial), which examined whether adding FPO to conventional cardiotocographic (CTG) monitoring (intervention group) was cost-effective in reducing operative delivery rates for non-reassuring fetal status compared with the use of CTG alone (control group). DESIGN: Cost-effectiveness analysis of the FOREMOST trial. SETTING: Four Australian maternity hospitals, each with more than 4000 births/year. POPULATION: Women in labour at > or =36 weeks of gestation, with a non-reassuring CTG. METHODS: Costs were for treatment-related expenses, incorporating diagnosis-related grouping costs and direct costs (including fetal monitoring). Incremental cost-effectiveness ratio (ICER) and cost-effectiveness plane were calculated, and sensitivity analysis was conducted. The primary outcome was that of the clinical trial: operative delivery for non-reassuring fetal status avoided in the intervention group relative to that in the control group. MAIN OUTCOME MEASURES: The ICER. RESULTS: The ICER demonstrated a saving of $A813 for each operative birth for non-reassuring fetal status averted by the addition of FPO to CTG monitoring compared with the use of CTG monitoring alone. CONCLUSION: The addition of FPO to CTG monitoring represented a less costly and more effective use of resources to reduce operative delivery rates for non-reassuring fetal status than the use of conventional CTG monitoring alone.

Vibroacoustic stimulation for fetal assessment in labour in the presence of a nonreassuring fetal heart rate trace.

BACKGROUND: Fetal vibroacoustic stimulation is a simple, non-invasive technique where a device is placed on the maternal abdomen over the region of the fetal head and sound is emitted at a predetermined level for several seconds. It is hypothesized that the resultant startle reflex in the fetus and subsequent fetal heart rate acceleration or transient tachycardia following vibroacoustic stimulation provide reassurance of fetal well-being. This technique has been proposed as a tool to assess fetal well-being in the presence of a non-reassuring cardiotocographic trace during the first and second stages of labour. OBJECTIVES: To evaluate the clinical effectiveness and safety of vibroacoustic stimulation in the assessment of fetal well-being during labour, compared with mock or no stimulation for women with a singleton pregnancy exhibiting a non-reassuring fetal heart rate pattern. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), MEDLINE (January 1966 to January 2005), EMBASE (January 1966 to January 2005) and reference lists of all retrieved articles. We sought unpublished trials and abstracts submitted to major international congresses and contacted expert informants. SELECTION CRITERIA: All published and unpublished randomised trials that compared maternal and fetal/neonatal/infant outcomes when vibroacoustic stimulation was used to evaluate fetal status in the presence of a non-reassuring cardiotocographic trace during labour, compared with mock or no stimulation. DATA COLLECTION AND ANALYSIS: Two independent review authors identified potential studies from the literature search and assessed them for methodological quality and appropriateness of inclusion, using a data extraction form. Attempts to contact study authors for additional information were unsuccessful. MAIN RESULTS: The search strategies yielded six studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review. AUTHORS' CONCLUSIONS: There are currently no randomised controlled trials that address the safety and efficacy of vibroacoustic stimulation used to assess fetal well-being in labour in the presence of a non-reassuring cardiotocographic trace. Although vibroacoustic stimulation has been proposed as a simple, non-invasive tool for assessment of fetal well-being, there is insufficient evidence from randomised trials on which to base recommendations for use of vibroacoustic stimulation in the evaluation of fetal well-being in labour in the presence of a non-reassuring cardiotocographic trace.

Fetal pulse oximetry for fetal assessment in labour.

BACKGROUND: Fetal pulse oximetry (FPO) may contribute to the evaluation of fetal well-being during labour. OBJECTIVES: To compare the effectiveness and safety of FPO with conventional surveillance techniques, using the results of randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (31 July 2004) and conducted a systematic literature search of MEDLINE (1994 to July 2004), EMBASE (1994 to July 2004) and Current Contents (1994 to July 2004). SELECTION CRITERIA: All published and unpublished randomised controlled trials (RCTs) that compared maternal and fetal/neonatal/infant outcomes when FPO was used in labour, with or without concurrent use of conventional fetal surveillance, compared with using cardiotocography (CTG) alone. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed data extraction. Analyses were performed on an intention-to-treat basis. We sought additional information from the investigators of the one reported trial. MAIN RESULTS: One published RCT (comparing FPO and CTG with CTG alone) was included; and two ongoing RCTs were identified. The single included RCT reported on 1010 cases. Unpublished pilot data were available for some outcomes to give a total of 1190 cases. There was no difference in the overall caesarean section rate between the two groups (relative risk (RR) 1.12, 95% confidence interval (CI) 0.91 to 1.37). There were less caesarean sections for nonreassuring fetal status in the FPO plus CTG group compared with the CTG only group (RR 0.45, 95% CI 0.28 to 0.72). The only reported neonatal seizure occurred in the CTG only group (RR 0.29 95% CI 0.01 to 7.08). Use of FPO with CTG decreased operative delivery (caesarean section, forceps, vacuum) for nonreassuring fetal status (RR 0.71, 95% CI 0.55 to 0.93) compared with CTG alone. No differences were seen for overall operative deliveries, endometritis, intrapartum or postpartum haemorrhage, uterine rupture, low Apgar scores, umbilical arterial pH or base excess, admission to the neonatal intensive care unit or fetal/neonatal death. REVIEWERS' CONCLUSIONS: The one published RCT reported that FPO decreased the caesarean section rate and operative delivery rates for nonreassuring fetal status, without adversely affecting maternal or fetal/neonatal outcomes. However, no difference was seen in the overall caesarean section (CS) or operative delivery rates because more CS were performed for dystocia in the FPO group. Further RCTs may address dystocia in labours monitored with FPO, maternal satisfaction with fetal monitoring and labour, long-term neurodevelopmental outcome of infants who exhibited nonreassuring fetal status in labour and costs of FPO.

Fate of abstracts published in the proceedings of the first annual Perinatal Society of Australia and New Zealand Congress in 1997.

OBJECTIVES: To examine the fate of research presented at the first annual Perinatal Society of Australia and New Zealand (PSANZ) Congress in 1997, by determining: the rate of publication in peer-reviewed biomedical journals; publication rate by discipline; journals in which work was published; concordance for aims, conclusions, authors and number of study subjects; and time from presentation to publication. METHODS: A MEDLINE search was conducted for any publication in a peer-reviewed journal resulting from a publishable abstract from the proceedings of the first annual PSANZ Congress in 1997. Searching was completed 42 months post-congress. The concordance of aims, conclusions, authors and number of subjects between abstract and published paper was determined. RESULTS: There were 172 publishable abstracts in the proceedings of the PSANZ Congress in 1997, and 78 (45%) were published as 83 articles. Basic sciences had the highest publication rate (67%) and midwifery the lowest (20%). Articles were published in 41 journals, with one-third of the articles in three paediatric journals. There was a match with aims in 75%, and with conclusions in 65%. There were 47/77 with the same number of subjects, 20/77 with more and 10/77 with fewer. There were 22 articles with one author added, 12 had more than one author added, 11 had one author removed and five had more than one author removed. Median time-to-publication was 18 months (interquartile range 9-26 months). CONCLUSIONS: A publication rate of 45% is comparable to other conferences. Basic science and neonatology had the highest publication rates. There were considerable differences between abstract and published article in terms of aims, conclusions, number of subjects and authors.

Clinicians' perceptions of placing a fetal oximetry sensor.

The aim of this study was to determine clinicians' perceptions of placing a fetal oximetry sensor. A survey was developed seeking details of staff category, birth suite experience, previous sensor placement, ease of application and use of epidural analgesia. Following staff feedback, the survey was revised from asking clinicians to rate women's comfort during sensor placement, to a visual analogue scale (VAS) of the clinician's assessment of the women's pain during sensor placement. Survey validity was sought from experts during development and for specific questions using item-total correlation in this analysis. Ease of sensor placement (n = 131) was rated as good or excellent 71% of the time. Clinicians rated women's comfort during sensor placement as good or excellent in 90% of cases. Median pain VAS was 0 (range 0-7.5). Item-total correlations of survey questions were all significant. Fetal oximetry sensor placement was rated well by clinicians in this purpose-designed survey.

Fetal pulse oximetry. Instrumentation and recent clinical experience.

Despite the pressing clinical need to improve fetal intrapartum surveillance, fetal oximetry has lagged well behind its application in the neonate because of the difficulty of developing a suitable method to record data from the fetus and testing its accuracy and reproducibility. Acceptable values of oxygen saturation that indicate fetal well-being are much lower than in neonates. The development of fetal pulse oximetry instrumentation is discussed. Recent clinical data acquired using the latest instrumentation are summarized and exciting new clinical applications proposed.

Fetal oxygen saturation and uterine contractions during labor.

Oxygen availability to the fetus during uterine contractions has not been widely reported. We examined whether fetal oxygen saturation (FSpO2) values and signal quality (SQ) were affected by uterine contractions. An intrauterine pressure catheter and a Nellcor FS14 fetal oxygen saturation sensor (Nellcor Puritan Bennett Inc., Pleasanton, CA) were placed transvaginally during the first stage of 17 labors. Fetal SPO2 and SQ units were recorded on a beat-to-beat basis and 10 sec averages of the data calculated over 25 contractions per patient. Five epochs were determined: (1) 30 sec prior to a contraction; (2) during a contraction; (3) 50 sec following completion of a contraction; (4) noncontraction periods, excluding epochs 1 or 3; and (5) equivocal, that is, overlap of epochs 1-3. Mean FSpO2 was lowest during epoch 3 (45.0) and highest during epoch 2 (47.3%) (p <0.001). This small difference is unlikely to be of any clinical significance, however. Mean signal quality was lowest in epoch 1 (42.8 units) and highest in epoch 4 (48.0 units) (p <0.05), that is, in noncontraction periods. We conclude that FSpO2 and SQ were unaffected by uterine contractions.

Fetal oxygen saturation during maternal bearing down efforts in the second stage of labor.

Fetal oxygen saturation (FSpO2) was monitored with the Nellcor Puritan Bennett N400/FS14 system during 16 labors to establish whether FSpO2 was influenced by maternal bearing down efforts in the second stage of labor. Fetal SpO2 is reported for 16 fetuses where neonatal outcome was normal. One hour of continuous data was recorded: 30 min prior to the onset of maternal bearing down efforts and the first 30 min of pushing. The hour was divided into six epochs of 10-min duration. Differences between mean FSpO2 for the two 30 min of monitoring and for each epoch were sought using repeated measures analysis of variance (ANOVA). The mean FSpO2 for the total 30 min prior to the onset of pushing was 49% (95% confidence intervals 46.5-50.6%), compared to a mean of 46% (95% confidence intervals 43.6-48.7%) during the first 30 min of pushing [F (1, 2.25), p = 0.14]. There was no significant decline in mean FSpO2 for each epoch. Apgar scores at 5 min were all > 7 and umbilical arterial pH values were > or = 7.20 (n = 12). We concluded that mean FSpO2 recorded prior to the onset of maternal bearing down efforts was not significantly different to mean FSpO2 during pushing, with normal neonatal outcome.

Stability of women's perceptions of fetal intrapartum oximetry.

We have previously reported women's perceptions of their experience with fetal intrapartum oxygen saturation monitoring and participation in a research project, assessed within a few days of delivery when the "halo effect' may have influenced responses. To determine whether women's perceptions had changed over time, we sent a second, identical questionnaire to the 49 women in the original sample who had delivered 3-12 months previously. Thirty-eight questionnaires were returned. Wilcoxon signed rank sum test was used to compare the ratings. Women's responses to the first and second questionnaire were not significantly different. Written comments were provided by 23 (61%) of the women. This stability of women's perceptions over time suggests that the original practice of surveying within a few days of delivery accurately reflects women's evaluation of their experience with the research project.

Fetal oxygen saturation monitoring in labour: an analysis of 118 cases.

Fetal oxygen saturation (FSpO2) was recorded during labour to determine the relationship between FSpO2 and indicators of fetal well-being, including umbilical blood gases, xanthine (X), hypoxanthine (Hx) and Apgar scores. This is one of the largest reported series of fetal pulse oximetry, with 118 fetuses monitored for over 329 hours. Mean FSpO2 for all cases was 46.9% (SD = 9.1%). There was no correlation between FSpO2 during the last 10 minutes of monitoring and arterial pH, Hx or X. A mean FSpO2 > or = 30% was associated with a 5 minute Apgar score of > or = 7 in the majority of cases. One fetus had a mean FSpO2 < 30% during the final 10 minutes of monitoring and an umbilical arterial pH < 7.20, while there were 10 fetuses with an umbilical arterial pH < 7.20, and mean FSpO2 > or = 30%. As these numbers are small, a larger series is necessary to further characterize the small number of fetuses who are significantly hypoxic.

Women's evaluations of their experience with fetal intrapartum oxygen saturation monitoring and participation in a research project.

OBJECTIVE: To evaluation women's perceptions of their participation in a research project in labour and their experience with fetal oxygen saturation monitoring. DESIGN: Survey using a questionnaire of women's rating of ten aspects of their experience with the project. SETTING: Royal Women's Hospital, Brisbane, Australia. PARTICIPANTS: Women who had participated in clinical observational studies of fetal intrapartum oxygen saturation monitoring. FINDINGS: 78 questionnaires were distributed and 77 returned. Overall, women evaluated their participation in this research project favourably, in terms of both their involvement in the research study and the use of fetal oxygen saturation monitoring. Several women commented that they appreciated the additional support they received form the research midwife. KEY CONCLUSIONS: Responses indicated that the women surveyed appreciated the opportunity to participate in research, were not averse to this new technology, and benefited from the perceived additional human contact and support they received. The high response rate to the questionnaire indicates that childbearing women are willing to be included in assessing the appropriateness of new birth technologies that may affect the well-being of women and babies in the future.

Human fetal intrapartum oxygen saturation monitoring: agreement between readings from two sensors on the same fetus.

OBJECTIVE: Our purpose was to assess the level of agreement between oxygen saturation values obtained from two identical sensors used on different sides of the face of the same human fetus during labor. STUDY DESIGN: Two identical fetal pulse oximeter sensors were placed on 12 fetuses during uncomplicated labor at < or = 38 weeks' gestation. Oxygen saturation, fetal heart rate, and uterine activity were recorded. The agreement between synchronous values of oxygen saturation was assessed by calculating the mean difference and SD of the difference. The SD of a single sensor was estimated as the SD of the difference divided by the square root of 2. RESULTS: The mean oxygen saturation value returned from one sensor was 49.2% and from the other 49.9%; the mean difference was -0.7%. The SD of the difference was 7.5%, and the 95% limits (+/- 2 SDs of the difference) were -15.5% to 14.1%. The SD from a single sensor was estimated as 5.3%. CONCLUSIONS: There was no clinically significant difference between the oxygen saturation values returned from two identical sensors on the one fetus. The magnitude of the SD from a single sensor must be taken into account when an arbitrary "cutoff" or "action" oxygen saturation value in a clinical setting or trial is defined.