A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour

Background: Almost one third of women suffer continuous lower back pain during labour. Evidence from three systematic reviews demonstrates that sterile water injections (SWI) provide statistically and clinically significant pain relief in women experiencing continuous lower back pain during labour. The most effective technique to administer SWI is yet to be determined. Therefore, the aim of this study is to determine if the single injection SWI technique is no less effective than the routinely used four injection SWI method in reducing continuous lower back pain during labour.Methods/design: The trial protocol was developed in consultation with an interdisciplinary team of clinical researchers. We aim to recruit 319 women presenting at term, seeking analgesia for continuous severe lower back pain during labour. Participants will be recruited from two major maternity hospitals in Australia. Randomised participants are allocated to receive a four or single intradermal needle SWI technique. The primary outcome is the change in self-reported pain measured by visual analogue scale at baseline and thirty minutes post intervention. Secondary outcomes include VAS change scores at 10, 60, 90 and 120 min, analgesia use, mode of birth and maternal satisfaction.Statistical analysis: Sample size was calculated to achieve 90% power at an alpha of 0.025 to detect a non-inferiority margin of ≤ 1 cm on the VAS, using a one-sided, two-sample t-test. Baseline demographic and clinical characteristics will be analysed for comparability between groups. Differences in primary (VAS pain score) and secondary outcomes between groups will be analysed by intention to treat and per protocol analysis using Student's t-test and ANOVA.Conclusion: This study will determine if a single intradermal SWI technique is no less effective than the routinely used four injection technique for lower back pain during labour. The findings will allow midwives to offer women requesting SWI during labour an evidence-based alternative technique more easily administered by staff and accepted by labouring women. Trial Registration: ACTRN12609000964213

Association between lamellar body count and respiratory distress in neonates

Objectives: Assessment of fetal lung maturity by a simple and rapid test has a pivotal role in obstetric managements. Lack of modern laboratory techniques in our country made us investigate whether lamellar body count (LBC) can be applied efficiently in the evaluation of fetal lung maturity. Methods: Lamellar body count was assessed in 104 unspun amniotic fluid samples taken from pregnant women admitted at Akbar Abadi Hospital, Tehran, Iran between May 2003 and November 2003 whose fetuses were at risk for respiratory distress syndrome (RDS). Cut-off points for LBC were determined to evaluate the risk of RDS. Standard clinical and radiographic criteria were used to diagnose RDS. Results: An LBC of less than 10,000 was 99.1 specific for lung immaturity (positive predictive value = 99.1, negative predictive value = 83.5). The LBCs of greater than 45,000 eliminates RDS (negative predictive value = 98.9). Conclusion: Lamellar body count is an easy, rapid and cost-effective test to assess fetal lung maturity in high-risk fetuses. Using the cut-off points of 10,000 and 45,000, LBC can serve as the first screening test of fetal lung maturity

Amniotic fluid lamellar body count: A predictor of respiratory distress in newborns

Introduction: Assessment of fetal lung maturity by a simple and rapid test has a pivotal role in obstetric managements. Considering lack of modern laboratory techniques in Iran This study was designed to investigate lamellar body count as an efficient method in evaluation of fetal lung maturity. Methods: Lamellar body count was assessed in 104 unspun amniotic fluid samples taken from pregnant women who referred to Akbarabadi hospital in year 2004 whose fetuses were at risk for respiratory distress syndrome. Sysmex K.800 was used to count lamellar bodies. Cut-off points for Lamellar body count were determined to evaluate the risk of respiratory distress syndrome. Standard clinical and radiographic criteria were used to diagnose respiratory distress syndrome. Sensitivity, specificity, positive and negative predictive values were calculated using SPSS11. Results: Lamellar body count of less than 10,000 was 99.1 specific for lung immaturity (positive predictive value = 99.1, negative predictive value = 83.5). Lamellar body count of greater than 45,000 eliminated respiratory distress syndrome (negative predictive value = 98.9). Conclusion: Lamellar body count is an easy, rapid and cost-effective test to assess fetal lung maturity in high-risk fetuses. Using the cut-off points of 10,000 and 45,000, lamellar body count can serve as the first screening test of fetal lung maturity

The effects of sequential use of oxytocin and sublingual nitroglycerin in the cases of retained placenta

Objectives: To evaluate the effects of adding sublingual nitroglycerin to oxytocin, for delivery of retained placenta after vaginal delivery. Method: The study was performed as a placebo controlled clinical trial on women who did not finish delivering placenta after 30 min of active management of the third stage of labor. In case group, 1 mg nitroglycerin and in the control group, placebo was prescribed sublingually. Results: In total, 80 women finished the study. The number of manual removal of placenta did not show significant difference between the two groups 25 women (62.5%) in the case and 30 women (75%) in the control group, p = 0.335. There was no significant difference between the two groups according to duration of the third stage of labor, hemoglobin index, decline in HB index >30% and maternal vital signs after treatment. There was no significant difference between the two groups according to adverse effects eight women (20%) in the case group and four (10%) in the control group (p = 0.348). Conclusion: The sequential use of oxytocin and sublingual nitroglycerin could not lead to delivery of more placentas and did not reduce the necessity of manual removal of placenta in comparison with placebo. © 2015 Taylor & Francis

Subcutaneous sterile water injection for labour pain: A randomised controlled trial

Background: About 30 of women experience severe continuous low-back pain in labour, but limited options are available to reduce this pain especially in developing countries and remote areas. Aims: To evaluate the efficacy of subcutaneous sterile water injection in reduction of labour pain compared with placebo. Methods: One hundred (100) consecutive patients were enrolled in a double-blind randomised controlled trial. During the first stage of labour with planned normal vaginal delivery, the intervention group (n = 50) received 0.5 mL sterile water injected subcutaneously and the control group (n = 50) received normal saline as a placebo. Pain score was measured before and 10 and 45 min after the injection, using the faces rating scale. Main outcome measure: Low-back labour pain. Results: The two groups were not significantly different regarding maternal age and weight, gestational age, parity and gravidity and degree of effacement. The median pain score was equal in both groups prior to the injection. Pain severity was reduced in both groups after the injection. However, the median pain score in the sterile water group was significantly lower than the placebo group 10 min (P < 0.01), as well as 45 min, after theinjection (P < 0.01). Conclusions: Administering one subcutaneous injection of sterile water in a painful point of the lumbosacral area is effective in reducing low-back pain during labour. © 2006 The Authors Journal compilation © 2006 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Impact on Caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial

Background: Sterile water injections have been used as an effective intervention for the management of back pain during labour. The objective of the current research is to determine if sterile water injections, as an intervention for back pain in labour, will reduce the intrapartum caesarean section rate.Methods/design: Design: A double blind randomised placebo controlled trial. Setting: Maternity hospitals in Australia. Participants: 1866 women in labour, ≥18 years of age who have a singleton pregnancy with a fetus in a cephalic presentation at term (between 37 + 0 and 41 + 6 weeks gestation), who assess their back pain as equal to or greater than seven on a visual analogue scale when requesting analgesia and able to provide informed consent.Intervention: Participants will be randomised to receive either 0.1 to 0.3 millilitres of sterile water or a normal saline placebo via four intradermal injections into four anatomical points surrounding the Michaelis' rhomboid over the sacral area. Two injections will be administered over the posterior superior iliac spine (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial to the PSIS respectively.Main outcome measure:Proportion of women who have a caesarean section in labour.Randomisation: Permuted blocks stratified by research site.Blinding (masking):Double-blind trial in which participants, clinicians and research staff blinded to group assignment.Funding:Funded by the National Health and Medical Research Council. Trial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954).Discussion: Sterile water injections, which may have a positive effect on reducing the CS rate, have been shown to be a safe and simple analgesic suitable for most maternity settings. A procedure that could reduce intervention rates without adversely affecting safety for mother and baby would benefit Australian families and taxpayers and would reduce requirements for maternal operating theatre time. Results will have external validity, as the technique may be easily applied to maternity populations outside Australia. In summary, the results of this trial will contribute High level evidence on the impact of SWI on intrapartum CS rates and provide evidence of the analgesic effect of SWI on back pain