METHODS: A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion.
RESULTS: Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different.
CONCLUSION: Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards.
TRIAL REGISTRATION: This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.
METHODS AND ANALYSIS: This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.
ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.
TRIAL REGISTRATION NUMBER: ISRCTN87414969, registered 3 May 2019.
Methods: In this study, to find published articles electronically from 2006 to 2019, the published articles in national and international databases of SID, MagIran, IranMedex, IranDoc, Google Scholar, Cochrane Library, Embase, ScienceDirect, Scopus, PubMed, and Web of Science (ISI) were used. Heterogenic index between studies was determined by Cochrane test (Q)c and I2. Due to heterogeneity, the random effects model was used to estimate standardize difference of the mean score of lavender test in order to assess the labor pain between intervention and control group.
Results: In this meta-analysis and systematic review, finally 13 eligible articles met the inclusion criteria of the study. The sample size from original studies enrolled in the meta-analysis entered in the intervention group was 794 individuals and in the control group was 795 individuals. Mean score for pain in the control group was 7.2 ± 0.42 and in the intervention group was 5.4 ± 0.58 and this difference was statistically significant (p ≤ 0.001).
Conclusion: The results of this study showed that lavender can reduce labor pain, which can be considered by health policy makers and gynecologists.