METHODS: This randomized controlled trial was conducted at the University Malaya Medical Center, Kuala Lumpur, Malaysia, from December 12, 2018, to May 28, 2019. A total of 78 term women scheduled for labor induction with one previous cesarean delivery who had ripe cervixes, singleton gestation, cephalic presentation, intact membranes, and reassuring cardiotocogram were randomized to Foley catheter or dinoprostone insert. The primary outcome was induction-to-delivery interval (in hours) and the secondary outcomes included maternal satisfaction on birth experience (assessed by 100-mm visual analog scale).
RESULTS: Induction-to-delivery intervals were as follows: median 33.5 h (interquartile range [IQR], 26.1-36.2 h) versus 23.5 h (IQR, 12.7-34.5 h) (P = 0.004), and maternal satisfaction on birth process 100-mm visual analog scale was 80 mm (IQR, 64-88 mm) versus 82 mm (IQR, 67-88 mm) (P = 0.919) for the Foley and controlled-release dinoprostone arms, respectively. Cesarean delivery rates were 23 of 39 (59%) versus 20 of 39 (51%) (relative risk, 1.15 [95% confidence interval, 0.77-1.72]) (P = 0.496) and trial device insertion to removal time mean ± standard deviation was 20.1 ± 7.1 h versus 14.2 ± 7.3 h (P = 0.001) for Foley versus controlled-release dinoprostone, respectively.
CONCLUSION: In term women after one previous cesarean delivery with unripe cervixes, controlled-release dinoprostone vaginal insert compared with Foley catheter shortens the induction-to-delivery interval but maternal satisfaction was not significantly increased.
CLINICAL TRIAL REGISTRATION: This study was registered with ISRCTN on November 30, 2018, with trial identification number: ISRCTN16957529 (https://doi.org/10.1186/ISRCTN16957529). The first participant was recruited on December 12, 2018.
METHODS: A randomized controlled trial was carried out in a university hospital in Malaysia. Women with lifestyle-controlled gestational diabetes scheduled to receive clinically indicated antenatal corticosteroids (dexamethasone) were randomized to 12-mg 12 hourly for one day (2 × 12-mg) or 6-mg 12-hourly for two days (4 × 6-mg). 6-point (pre and 2-h postprandial) daily self-monitoring of capillary blood sugar profile for up to 3 consecutive days was started after the first dexamethasone injection. Hyperglycemia is defined as blood glucose pre-meal ≥ 5.3 or 2 h postprandial ≥ 6.7 mmol/L. The primary outcome was a number of hyperglycemic episodes in Day-1 (first 6 BSP points). A sample size of 30 per group (N = 60) was planned.
RESULTS: Median [interquartile range] hyperglycemic episodes 4 [2.5-5] vs. 4 [3-5] p = 0.3 in the first day, 3 [2-4] vs. 1 [0-3] p = 0.01 on the second day, 0 [0-1] vs. 0 [0-1] p = 0.6 on the third day and over the entire 3 trial days 7 [6-9] vs. 6 [4-8] p = 0.17 for 6-mg vs. 12-mg arms, respectively. 2/30 (7%) in each arm received an anti-glycemic agent during the 3-day trial period (capillary glucose exceeded 11 mmol/L). Mean birth weight (2.89 vs. 2.49 kg p
METHODS: Parous women with favorable cervixes after amniotomy for labor induction were randomized to immediate titrated oxytocin or placebo intravenous infusion in a double-blind noninferiority trial. After 4 hours, study infusions were stopped, the women were assessed, and open-label oxytocin was started if required. Maternal satisfaction with the birth process was assessed with a 10-point visual numerical rating scale (lower score, greater satisfaction).
RESULTS: Vaginal delivery rates at 12 hours were 91 of 96 (94.8%) compared with 91 of 94 (96.8%) (relative risk 0.98, 95% confidence interval [CI] 0.92-1.04, P=.72), and maternal satisfaction on a visual numerical rating scale (median [interquartile range]) was 3 [3-4] compared with 3 [3-5], P=.36 for immediate compared with delayed arm, respectively). Cesarean delivery, maternal fever, postpartum hemorrhage, uterine hyperactivity, and adverse neonatal outcome rates were similar between arms. The immediate oxytocin arm had a shorter amniotomy-to-delivery interval of 5.3±3.1 compared with 6.9±2.9 hours (P
METHODS: In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants.
RESULTS: At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified.
CONCLUSIONS: The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.