METHODS: A randomized trial was conducted from September 2020 to March 2021. A total of 140 term nulliparas (70 early amniotomy, 70 delayed amniotomy) with Foley catheter-ripened cervices (dilatation ≥3 cm achieved), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing were recruited. Women were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy or delayed amniotomy (after 4 h of oxytocin). The primary outcome was intervention (oxytocin)-to-delivery interval (h).
RESULTS: Intervention-to-delivery intervals (h) were mean ± standard deviation 9.0 ± 3.6 versus 10.6 ± 3.5 h (mean difference of 1.4 h) (P = 0.004) for the early versus delayed amniotomy arms, respectively. Birth rates at 6 h after oxytocin infusion were 19 of 70 (27.1%) versus 8 of 70 (11.4%) (relative risk, 2.38 [95% confidence interval (CI), 1.11-5.06]; number needed to treat: 7 [95% CI, 3.5-34.4]) (P = 0.03), cesarean delivery rates were 29 of 70 (41.4%) versus 33 of 70 (47.1%) (relative risk, 0.88; 95% CI, 0.61-1.28) (P = 0.50), and maternal satisfaction on birth process were a median of 7 (interquartile range, 7-8) versus 7 (interquartile range, 7-8) (P = 0.40) for the early versus delayed amniotomy arms, respectively.
CONCLUSION: In term nulliparas with cervices ripened by Foley catheter, immediate oxytocin and early amniotomy compared with a planned 4-h delay to amniotomy shortened the intervention-to-delivery interval but did not significantly reduce the cesarean delivery rate.
METHODS: This randomized trial was conducted in Malaysia in 232 term multiparous women with balloon catheter-ripened cervixes (dilatation ≥3 cm), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing. They were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy (116) or delayed amniotomy after 4 h of oxytocin (116). Primary outcome was intervention (oxytocin initiation)-to-delivery interval.
RESULTS: Oxytocin-to-delivery intervals were a median of 4.99 h (interquartile range [IQR], 3.21-7.82 h) versus 6.23 h (IQR, 4.50-8.45 h) (P
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 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
METHOD: In this prospective observational cohort study, 769 women prior to their labor induction had sleep and psychological well-being assessed using Pittsburgh Sleep Quality Index and Depression, Anxiety and Stress Scales. Women were asked about the adequacy of labor induction information provided and their involvement and time pressure felt in the decision-making for their labor induction. Maternal characteristics, induction and intrapartum care measures, and labor and neonatal outcomes were also assessed. Prior to discharge, women rated their satisfaction with their birth experience.
RESULTS: A total of 34 variables were considered for bivariate analysis, with 15 found to have P
METHODS: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and consented. Participants were randomized to oral polyethylene glycol (10 g/day) or lactulose (10 g/day) for 4 weeks. A bowel movement diary was kept and outcomes using the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM), Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) and Bristol Stool Form Scale (BSFS), which were evaluated at the start and end of the four-week period. Relative risks (RR) were determined for the coprimary outcomes of complete spontaneous bowel movement (CSBM) and PAC-SYM mean score improvement (decrease in score of >1 from the baseline).
RESULTS: A total of 4323 women underwent screening, of which 780 fulfilled the Rome IV criterion, and 360 consented to participate (180 randomized to PEG and lactulose, respectively). Data from 247 women who completed the study were analyzed. CSBM was achieved in 107/124 (86.3%) versus 102/123 (82.9%) (RR 1.04, 95% CI: 0.93-1.16, P = 0.464) for PEG and lactulose trial arms, respectively. PAC-SYM mean score improvement was 62/118 (52.5%) in the PEG arm versus 44/118 (37.3%) in the lactulose arm (RR 1.40, 95% CI: 1.05-1.88). Of secondary outcomes, a significant difference was found in favor of PEG, with respect to PAC-SYM abdominal symptoms subscale, normal stool versus loose stool consistency and side effects of vomiting and diarrhea. After controlling for parity, baseline PAC-SYM, PAC-QoL scores, characteristics different at baseline, only diarrhea and loose stools remained significant.
CONCLUSION: Both PEG 4000 and lactulose are effective laxatives in pregnancy with similar performance after adjusted analysis. Diarrhea and loose stools are less frequently reported with PEG.
METHODS: This randomized trial was conducted in a tertiary university hospital in Malaysia from September 2020 to February 2022. A total of 330 nulliparous women at term with unripe cervices (Bishop score ≤5), singleton viable fetus in cephalic presentation, reassuring preinduction fetal heart rate tracing and intact membranes who underwent planned outpatient Foley catheter induction of labor (IOL) were included. Women were randomized to expectant or immediate return to hospital if the Foley was spontaneously expelled at home before their scheduled hospital admission the following day. Primary outcomes were amniotomy-titrated oxytocin infusion to delivery interval and maternal satisfaction on the induction process (assessed by 0-10 visual numerical rating scale [VNRS]).
RESULTS: Amniotomy-titrated oxytocin infusion to delivery interval was 8.7 ± 4.1 versus 8.9 ± 3.9 h, P = 0.605 (mean difference - 0.228 95% CI: -1.1 to +0.6 h) and maternal satisfaction VNRS score was median (interquartile range) 8 (7-9) versus 8 (7-9), P = 0.782. Early return to hospital rates were 37/165 (22.4%) versus 72/165 (43.6%), RR 0.51 (95% CI: 0.37-0.72), P ≤ 0.001, Cesarean delivery rates were 80/165 (48.5%) versus 80/165 (48.5%), RR 1.00 (95% CI: 0.80-1.25), P = 1.00 and duration of hospital stay was 54.4 ± 22.9 versus 56.7 ± 22.8 h, P = 0.364 for the expectant versus immediate return groups respectively.
CONCLUSION: In outpatient Foley catheter IOL, expectant compared to immediate return to hospital following Foley dislodgement results in similarly high maternal satisfaction. The amniotomy-titrated oxytocin to delivery duration is non-inferior with expectant management.
METHODS: A total of 124 women hospitalized for HG from February 10, 2021 till January 6, 2023 were randomized to ORT (n = 61) or IVT (n = 63) for an initial 12 h. Inclusion criteria includes women older than 18 years, with a viable intrauterine pregnancy less than 14 weeks at their first hospitalization for HG with ketonuria of at least 2+. Primary outcomes were (1) satisfaction score with allocated intervention, (2) weight change, and (3) ketonuria change at 12 h. Secondary outcomes included vomiting frequency, nausea score, serial vital signs, hematocrit and electrolyte levels at 12 h, deviation from treatment protocol (cross-over therapy), participant recommendation of allocated treatment to a friend, and length of hospital stay.
RESULTS: Primary outcomes of (1) participant satisfaction score (on a 0-10 visual numerical rating scale) was 7 (interquartile range [IQR] 5-8) versus 9 (IQR 8-10), P
METHODS: Over a 3-year period a group of pregnant women with cardiac disease was followed until 6 weeks postpartum. Twenty women with pulmonary hypertension were compared with 20 controls without pulmonary hypertension with particular reference to maternal and fetal outcome. Analysis of data was carried out using Fisher's exact test and Student's t-test.
RESULTS: Except for Eisenmenger's syndrome, there were no differences in maternal morbidity and mortality between the two groups. There were more low birth weight babies but no significant differences in premature delivery rate, mode of delivery or perinatal mortality.
CONCLUSION: Except for Eisenmenger's syndrome, coexisting pulmonary hypertension complicating cardiac disease in pregnancy generally has a favorable outcome for both mother and fetus.