Safety of misoprostol vaginal insert for labor induction using standard vs. adjusted retrieval criteria: a comparative cohort study.

Objective To compare the safety of misoprostol vaginal insert (MVI) for labor induction using standard and adjusted criteria. Methods This was a single-center, comparative cohort study of 138 pregnant women ≥37/0 weeks undergoing labor induction with MVI using standard (69 women; administration for up to 24 h; MVI-24) or adjusted (69 women; administration for up to 10 h; MVI-10) criteria in a tertiary academic center in Germany. The main maternal safety outcomes were the rate of tachysystole and rate of tachysystole requiring tocolysis. Neonatal safety assessments included Apgar score at 5 min and postpartum arterial fetal pH. Results Uterine tachysystole occurred in more women in the MVI-24 group compared with the MVI-10 group [47.8% vs. 25.5%; P = 0.001; relative risk (RR) 2.36 (95% confidence interval [CI]: 1.39-4.00)] and as did uterine tachysystole requiring tocolysis [MVI-24: 26.1% vs. MVI-10: 11.6%; P = 0.049; RR 2.25 (95% CI: 1.05-4.83)]. The mean 5-min Apgar scores were 9.64 for the MVI-24 group and 9.87 for the MVI-10 (P = 0.016). Low postpartum umbilical arterial pH values occurred more often in the MVI-24 compared with the MVI-10 group (pH 7.10-7.19: 26.1% vs. 20.3% and pH <7.10: 4.4% vs. 0.0%, respectively). Conclusion Adjusted retrieval criteria for MVI of up to 10 h exposure instead of the standard 24 h reduced uterine tachysystole and improved the neonatal outcome.

Standard and adjusted criteria for the use of the misoprostol vaginal insert for labor induction: a comparative cohort study.

Objective To compare the efficacy of misoprostol vaginal insert (MVI) for labor induction using standard and adjusted criteria. Methods A single-center, comparative cohort study using a consecutive series of pregnant women ≥37/0 weeks undergoing labor induction with either standard criteria for MVI (administration for up to 24 h; MVI-24) or with adjusted criteria (MVI administration for a maximum of 10 h; MVI-10) conducted at a tertiary academic center in Germany. The primary outcomes were the time from start of induction to any delivery and cesarean delivery rate. Results A total of 138 women were included in the study, 69 in each group. The mean time from MVI administration to any delivery showed no significant difference between the MVI-24 and MVI-10 groups (954 vs. 969 min, respectively; P = 0.679). The cesarean delivery rate was proportionally lower for the MVI-10 group [39.1% (27/69) vs. 24.6% (17/69); P = 0.10]. Conclusion The time from induction to delivery with MVI was similar when using standard criteria of up to 24 h of exposure vs. adjusted criteria of up to 10 h of exposure. Although the threshold for statistical significance for cesarean section was not attained, there is nonetheless a considerable difference between the MVI-24 and MVI-10 groups.

The misoprostol vaginal insert compared with oral misoprostol for labor induction in term pregnancies: a pair-matched case-control study.

AIM: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM). METHODS: Pair-matched case-control study comparing the induction of labor with a retrievable MVI to OM. The primary outcomes were the time from induction to delivery and the cesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score. RESULTS: One hundred and thirty eight women ≥37/0 weeks pregnant undergoing labor induction with misoprostol were included. The mean time from application to delivery was significantly shorter and the caesarean section rate significantly higher in the MVI group (P<0.01) with an odds ratio of 2.75 (95% CI: 1.21-6.25) in favor of vaginal delivery in the OM group. The mean 5-min Apgar scores and arterial cord pH values were significantly lower in the MVI group. An arterial pH value of 7.10-7.19 was found in 26.1% and 15.9%, and a value <7.10 was found in 4.3% and 0% of MVI and OM cases, respectively. CONCLUSION: The MVI compared with OM significantly shortened the time from application to delivery at the expense of a higher cesarean section rate and negative effects on neonatal outcomes.

Calgranulins in cystic fluid and serum from patients with ovarian carcinomas.

Ovarian cancer remains still associated with poor prognosis because it is diagnosed predominantly at advanced stages. Ovarian-specific tumor markers do not yet exist for early detection of the disease. At the search of diagnostic markers for ovarian cancer, proteomic-based approaches have focused on novel investigations of neoplastic processes in tumor patients. Cystic fluids of malignant and benign ovarian tumors and serum from the corresponding patients were collected and processed for two-dimensional gel electrophoresis. Proteins were visualized on the gels by silver staining. At the low molecular mass level between 10 and 20 kDa, selected protein spots were additionally processed for nanospray mass spectrometry and partial amino acid sequencing. For protein identification, the sequencing results were compared with computer information from a protein data bank. Protein patterns from cystic fluids of ovarian carcinomas differed significantly from those of benign cysts and revealed additional polypeptides at low molecular mass level between 10 and 20 kDa. Protein patterns from serum of patients with malignant ovarian tumors also contained additional polypeptides between 10 and 20 kDa that were not detected in serum from patients with benign cysts. The additional proteins in serum were present in similar electrophoretic positions compared with those found in the cystic fluid of the corresponding ovarian carcinomas. Protein spots in the range of 10-20 kDa were selected for partial amino acid sequencing. Two protein spots were identified as calgranulin A and three spots as calgranulin B. Either both proteins or only calgranulin A or B were present in cystic fluid from ovarian carcinomas and serum of the corresponding patients. These two proteins were absent or not detectable in fluid from benign ovarian cysts and in serum from those patients. Our investigations concerning protein patterns in cystic fluid of malignant and benign ovarian tumors provide new information about alterations in protein synthesis linked to neoplastic events of the ovary. With the proteomic strategy, new tumor markers are characterized and may serve for diagnostic purposes of patients with ovarian cancer.