Dinoprostone vaginal slow-release system (Propess) compared to expectant management in the active treatment of premature rupture of the membranes at term: impact on maternal and fetal outcomes

Abstract

Background: Retrospective study of 744 women at the Virgen del Camino Hospital in Pamplona concerning two variants for the active treatment of premature rupture of the membranes (PROM). The main purpose of the study was to assess the differences between two variants for the active treatment of PROM at term in pregnant women with negative vaginal-rectal culture screening for Group B Streptococci, and a Bishop test of 4 or less on admission.

Methods: Retrospective study of 744 patients with single pregnancy at term, PROM, and Bishop test <4. The patients, who were not randomised, were treated with dinoprostone (Propess) or expectant therapy, according to the physician's choice. Induction with oxytocin was started 12 h after PROM. Qualitative data were analysed using the chi(2) test, while quantitative data were analysed using the Student's t-test or the Mann-Whitney U-test according to the distribution of the variables. Regression models were applied to correct the biases caused by confounding variables.

Results: Of the 744 patients, the cervix of 13% was maturated with pericervical dinoprostone, while 87% were subject to expectant management until 12 h after rupture of the membranes. The time of dilation and the time until labour were significantly shorter in the dinoprostone group (p=0.0). The rate of caesarean sections was also lower in the dinoprostone group at 9.3% compared to 17.6% in the expectant management group, reaching statistical significance (p=0.04). There were no differences in the parameters of fetal well being (Apgar and pH).

Conclusions: The use of therapy with dinoprostone in patients with PROM could be a safe method and more effective than expectant management.