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.

Real-time imaging as visual biofeedback in active second stage of labor among nulliparas: a randomized controlled trial.

BACKGROUND: A prolonged second stage of labor increases the risk of severe perineal laceration, postpartum hemorrhage, operative delivery, and poor Apgar score. The second stage is longer in nulliparas. Maternal pushing during the second stage of labor is an important contributor to the involuntary expulsive force developed by uterine contraction to deliver the fetus. Preliminary data indicate that visual biofeedback during the active second stage hastens birth. OBJECTIVE: This study aimed to evaluate if visual feedback focusing on the perineum reduced the length of the active second stage of labor in comparison with the control. STUDY DESIGN: A randomized controlled trial was conducted in the University Malaya Medical Centre from December 2021 to August 2022. Nulliparous women about to commence the active second stage, at term, with singleton gestation, reassuring fetal status, and no contraindication for vaginal delivery were randomized to live viewing of the maternal introitus (intervention) or maternal face (sham/placebo control) as visual biofeedback during their pushing. A video camera Bluetooth-linked to a tablet computer display screen was used; in the intervention arm, the camera was focused on the introitus, and in the control arm, on the maternal face. Participants were instructed to watch the display screen during their pushing. The primary outcomes were the intervention-to-delivery interval and maternal satisfaction with the pushing experience assessed using a 0-to-10 visual numerical rating scale. Secondary outcomes included mode of delivery, perineal injury, delivery blood loss, birthweight, umbilical cord arterial blood pH and base excess at birth, Apgar score at 1 and 5 minutes, and neonatal intensive care unit admission. Data were analyzed with the t test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate. RESULTS: A total of 230 women were randomized (115 to intervention and 115 to control arm). The active second stage duration (intervention-to-delivery interval) was a median (interquartile range) of 16 (11-23) and 17 (12-31) minutes (P=.289), and maternal satisfaction with the pushing experience was 9 (8-10) and 7 (6-7) (P<.001) for the intervention and control arm, respectively. Women randomized to the intervention arm were more likely to agree to recommend their management to a friend (88/115 [76.5%] vs 39/115 [33.9%]; relative risk, 2.26 [95% confidence interval, 1.72-2.97]; P<.001) and more likely to have less severe perineal injury (P=.018). CONCLUSION: Real-time viewing of the maternal introitus as visual biofeedback during pushing resulted in higher maternal satisfaction compared with the sham control of viewing the maternal face; however, the time to delivery was not significantly shortened.

Combined massage and warm compress to the perineum during active second stage of labor in nulliparas: A randomized trial.

OBJECTIVE: To evaluate the combined effect of massage and warm compress to the perineum (MassComp) compared with standard "hands-off" in the second stage of labor. METHODS: A randomized trial was conducted in a University hospital in Malaysia. Nulliparous women at term who were about to start pushing were randomized to massage during pushing and warm compress to the perineum in between pushes or to standard "hands-off" care. Primary outcome was suturing for perineal injury (episiotomy or tear). RESULTS: A total of 156 participants were analyzed based on intention to treat. Perineal repair rates were 53/79 (67%) for MassComp versus 70/77 (91%) for control (relative risk [RR] 0.72, 95% confidence interval [CI] 0.61-0.98, number needed to treat for an additional beneficial outcome [NNTb ] 5, 95% CI 2.83-8.62, P < 0.001). Of the secondary outcomes, participants' satisfaction with care (visual numerical rating scale 0-10; 8.3 ± 1.2 vs 7.8 ± 1.2, P = 0.014), major perineal injury (second degree or higher) rates 34/79 (43%) versus 51/77 (66%) (RR 0.72, 95% CI 0.58-0.97, NNTb 5, 95% CI 2.61-12.56, P = 0.004), episiotomy rates 28/79 (37%) versus 40/77 (53%) (RR 0.72, 95% CI 0.52-0.98, NNTb 8, 95% CI 3.63-36.46, P = 0.043), intervention to delivery intervals 29.5 ± 13.6 versus 27.9 ± 13.8 minutes (P = 0.472) and spontaneous vaginal delivery rates 63/79 (79.7%) versus 56/77 (72.7%) (RR 1.11, 95% CI 0.92-1.34, P = 0.306) for MassComp versus control, respectively. CONCLUSION: Massage and warm compress during pushing decreased the perineal suturing, major perineal injury, and episiotomy rates and improved maternal satisfaction. CLINICAL TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN42773879.