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A Randomised Controlled Trial Comparing Induction of Labour with the Propess Vaginal System to the Prostin Vaginal Tablet in Premature Rupture of Membranes at Term.

ABSTRACT: Aim: To compare the perinatal outcome and delivery intervals after the induction of labour with the Prostin vaginal tablet versus the Propess vaginal system in pregnant women with term-PROM. Design: One centre paralleled randomised controlled trial with a computer-generated table to allocate treatments. Setting: University Medical Centre in Slovenia. Participants: A total of 205 singleton healthy pregnant women with term-PROM. Intervention: Induction of labour with the Propess vaginal system (intervention group) versus Prostin tablets (control group). Main outcomes: The rate of failed inductions, complications in labour, time intervals between the PROM, induction, the beginning of the active phase, and delivery. Results: A total of 104 patients received Prostin, and 101 patients received Propess. Induction failure rates in the Prostin and the Propess groups were 8/104 (7.7%) and 5/101 (5.0%), respectively (p = 0.80). Delivery abnormalities were uncommon and comparable across the groups. The rates of caesarean sections in the Prostin and Propess groups were 4/96 (4.2%) and 6/96 (6.3%), respectively. The delivery intervals were comparable across the groups. Conclusions: In term-PROM pregnancies, the Propess vaginal system is a safe and effective option for inducing labour.

SUBMITTER: Anzeljc V

PROVIDER: S-EPMC9821379 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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A Randomised Controlled Trial Comparing Induction of Labour with the Propess Vaginal System to the Prostin Vaginal Tablet in Premature Rupture of Membranes at Term.

Anzeljc Veronika V Mujezinović Faris F

Journal of clinical medicine 20221226 1

Aim: To compare the perinatal outcome and delivery intervals after the induction of labour with the Prostin vaginal tablet versus the Propess vaginal system in pregnant women with term-PROM. Design: One centre paralleled randomised controlled trial with a computer-generated table to allocate treatments. Setting: University Medical Centre in Slovenia. Participants: A total of 205 singleton healthy pregnant women with term-PROM. Intervention: Induction of labour ...[more]

PMID: 36614975

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Project description:IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required.Ethics and disseminationWritten informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial registration numberNCT03310333.

Project description:BackgroundPreterm premature rupture of membranes (PPROM), which is associated with vaginal dysbiosis, is responsible for up to one-third of all preterm births. Consecutive ascending colonization, infection, and inflammation may lead to relevant neonatal morbidity including early-onset neonatal sepsis (EONS). The present study aims to assess the vaginal microbial composition of PPROM patients and its development under standard antibiotic therapy and to evaluate the usefulness of the vaginal microbiota for the prediction of EONS. It moreover aims to decipher neonatal microbiota at birth as possible mirror of the in utero microbiota.MethodsAs part of the PEONS prospective multicenter cohort study, 78 women with PPROM and their 89 neonates were recruited. Maternal vaginal and neonatal pharyngeal, rectal, umbilical cord blood, and meconium microbiota were analyzed by 16S rRNA gene sequencing. Significant differences between the sample groups were evaluated using permutational multivariate analysis of variance and differently distributed taxa by the Mann-Whitney test. Potential biomarkers for the prediction of EONS were analyzed using the MetaboAnalyst platform.ResultsVaginal microbiota at admission after PPROM were dominated by Lactobacillus spp. Standard antibiotic treatment triggers significant changes in microbial community (relative depletion of Lactobacillus spp. and relative enrichment of Ureaplasma parvum) accompanied by an increase in bacterial diversity, evenness and richness. The neonatal microbiota showed a heterogeneous microbial composition where meconium samples were characterized by specific taxa enriched in this niche. The vaginal microbiota at birth was shown to have the potential to predict EONS with Escherichia/Shigella and Facklamia as risk taxa and Anaerococcus obesiensis and Campylobacter ureolyticus as protective taxa. EONS cases could also be predicted at a reasonable rate from neonatal meconium communities with the protective taxa Bifidobacterium longum, Agathobacter rectale, and S. epidermidis as features.ConclusionsVaginal and neonatal microbiota analysis by 16S rRNA gene sequencing after PPROM may form the basis of individualized risk assessment for consecutive EONS. Further studies on extended cohorts are necessary to evaluate how far this technique may in future close a diagnostic gap to optimize and personalize the clinical management of PPROM patients.Trial registrationNCT03819192, ClinicalTrials.gov. Registered on January 28, 2019.

Project description:BackgroundPreterm premature rupture of membranes (PPROM) is closely associated with pathogenic microbiomes in the female reproductive tract, and can lead to neonatal septicemia. The current study aimed to investigate potential pathogenic microbiomes associated with neonatal septicemia based on DNA metagenome sequencing.MethodsIn this study, a total of 7 pregnant women with PPROM presenting neonatal septicemia (experimental group) and 3 pregnant women with normal newborns (control group) were enrolled. Vaginal secretions at admission and before parturition as well as placental tissues after parturition were collected for DNA metagenome sequencing using whole genome shotgun method on the Illumina NovaSeq/HiSeq platform. Raw data were processed by BioBakery workflow, and MetaPhlAn4 was implemented for qualitative and quantitative analyses of microbiome. Lactobacillus crispatus, Gardneralla vaginalis, Fannyhessea vaginae and Streptococcus suis were specifically detected from the experimental group. The two groups were compared using Student's t-tests.ResultsThe indexes of Chao1 (P=0.00028/P=0.00072), abundance-based coverage estimator (ACE, P=0.00059/P=0.00026), Shannon (P=0.036/P=0.0065) and Simpson (P=0.007/P=0.041) in the experimental group were increased at admission and before parturition as compared with the control group. Several microbiomes, such as Lactobacillus crispatus, Gardneralla vaginalis, Fannyhessea vaginae and Streptococcus suis, were specifically detected in the experimental group. Notably, Gardnerella vaginalis and Streptococcus gallolyticus were identified from the vaginal secretions and placenta tissues of women with neonatal septicemia. Moreover, nucleic acid synthesis and carbohydrate metabolism-related pathways were enriched in the experimental group.ConclusionThis study enhanced the current understanding of the mechanisms underlying pathogenic microbiomes in PPROM-induced neonatal septicemia. The trial registry number is ChiCTR2300070666 (URL: https://www.chictr.org.cn/showproj.html?proj=195648).

Dataset Information

A Randomised Controlled Trial Comparing Induction of Labour with the Propess Vaginal System to the Prostin Vaginal Tablet in Premature Rupture of Membranes at Term.

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A Randomised Controlled Trial Comparing Induction of Labour with the Propess Vaginal System to the Prostin Vaginal Tablet in Premature Rupture of Membranes at Term.

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