Self-monitoring of blood glucose two-weekly versus weekly in gestational diabetes on nutrition therapy: A randomized trial.

OBJECTIVE: To evaluate 4-point per day self-monitoring of blood glucose (SMBG) every 2 weeks compared with every week. METHODS: A total of 104 patients with lifestyle-controlled gestational diabetes (GDMA1) were randomized to 2-weekly or weekly 4-point per day (fasting on awakening and 2-h post-meals) SMBG. Primary outcome was the change in glycated hemoglobin (HbA1c) level from enrollment to 36 weeks of pregnancy across trial arms. The non-inferiority margin was an HbA1c increase of 0.2%. RESULTS: The mean difference for change in HbA1c from enrollment to 36 weeks was 0.003% (95% confidence interval [CI] -0.098% to +0.093%), within the 0.2% non-inferiority margin. The change in HbA1c level increased significantly within both trial arms-0.275% ± 0.241% (P < 0.001) in 2-weekly arm versus 0.277% ± 0.236% (P < 0.001) in the weekly arm. Participants randomized to 2-weekly SMBG were significantly less likely to receive anti-glycemic treatment-5/52 (9.6%) versus 14/50 (28.0%) (relative risk 0.34, 95% CI 0.13-0.88; P = 0.017). All secondary outcomes-maternal weight gain, preterm delivery, cesarean delivery, birthweight, and neonatal admission-were not significantly different. CONCLUSIONS: In GDMA1, 2-weekly is non-inferior to weekly SMBG on the change in HbA1c level. Two-weekly SMBG appeared to be adequate for monitoring women with GDMA1. CLINICAL TRIAL REGISTRATION: This study was registered in ISRCTN registry on March 25, 2022 with trial identification number: ISRCTN13404790 (https://doi.org/10.1186/ISRCTN13404790). The first participant was recruited on April 12, 2022.

Combined perineal massage and warm compress compared to massage alone during active second stage of labour in nulliparas: A randomised trial.

OBJECTIVE: To evaluate the effect of combined perineal massage and warm compress to the perineum (MassComp) compared to perineal massage alone during pushing in the second stage of labour in reducing perineal trauma requiring suturing in nulliparas. STUDY DESIGN: A randomised trial was performed in a University hospital, Malaysia from June 2020 to May 2021. 281 term nulliparas who were about to start pushing in the second stage of labour were randomised to combined perineal massage and warm compress or perineal massage alone to the perineum. Primary outcome was suturing for perineal injury (episiotomy or tear). The Chi-square test was used to analyse categorical data, Student t test to compare means and distributions for normally distributed continuous data and Mann Whitney U test for appropriate ordinal data. RESULTS: Data from 277 participants (140 MassComp arm, 137 perineal massage alone arm) were analysed based on modified intention to treat basis. Perineal suturing rates were 133/140(95.0%) [MassComp] vs. 128/137(93.4%) [perineal massage alone] RR 1.02(95%CI 0.96-1.08), P = 0.615. Of the secondary outcomes, Likert scale response to recommend allocated treatment to a friend was 103/140(73.6%) vs. 84/137(61.3%) RR 1.20(95%CI 1.02-1.42)NNTb 9(95%CI 4.3-76.4) P = 0.029, participants' satisfaction with care (visual numerical rating scale 0-10) median [interquartile range] 6[6-8] vs. 6[5-8] P = 0.392, intervention to delivery intervals were 25[15-35] vs. 19[14-30] minutes P = 0.012, major perineal injury (episiotomy, second degree or higher tears) rates 116/140(82.9%) vs. 119/137(86.9%) RR 0.95(95%CI 0.86-1.05), P = 0.404, episiotomy rates 97/140(69.3%) vs. 97/140(70.8%) RR 0.98(95%CI 0.84-1.14), P = 0.795, and spontaneous vaginal delivery rates 103/140(73.6%) vs. 106/137(77.4%) RR 0.95(95%CI 0.83-1.09), P = 0.488 for MassComp vs. perineal massage alone respectively. Other maternal and neonatal outcomes were not significantly different. CONCLUSION: Massage and warm compress during pushing did not decrease the likelihood of perineal injury requiring suturing in nulliparas when compared to perineal massage alone. Women were more likely to recommend massage and warm compress during pushing to a friend.