A randomised prospective clinical trial was conducted over a 7-year period (1987-1993) in the Department of Obstetrics and Gynaecology, University of Patras.
The purpose of this study was to compare two management protocols of Preterm Premature Rupture of Membranes (PPROM).
Two-hundred forty-one women entered the study and were assigned randomly to one of two groups.
Group A consisted of 105 subjects who were managed expectantly (tocolysis used for 48 h only, if necessary, to permit full course of steroid therapy), while Group B consisted of 136 subjects, in whom aggressive tocolysis was utilised.
The differences in the latency period (time from rupture of membranes to the onset of labour) were not statistically significant between the two groups.
On the contrary, statistically significant differences in the incidence of chorioamnionitis and postpartum endomyometritis were found between the two groups (higher in Group B).
Twelve subjects in Group A (12/105,11.4%) and 40 in Group B (40/136,29.4%) had choriamnionitis.
The relative risk (RR) was 2.47 (95% C.I. 1.42-4.66, P<0.001).
Endomyometritis was diagnosed in 20 subjects in Group A (20/105,19%) and in 45 in Group B (45/136,33.3%). The RR was 1.74 (95% C.I. 1.10-2.75, P<0.05).
These data suggest that long term prophylactic tocolytic therapy in patients with PPROM, while without demonstrated benefit, may result in an increased risk of maternal infectious morbidity, and raise the cost of treatment.
Mots-clés Pascal : Prévention, Toxicité, Homme, Femelle, Etude comparative, Chimiothérapie, Tocolytique, Coût, Grèce, Europe, Court terme, Long terme, Rupture prématurée membrane foetoplacentaire, Gestation pathologie
Mots-clés Pascal anglais : Prevention, Toxicity, Human, Female, Comparative study, Chemotherapy, Tocolytic, Costs, Greece, Europe, Short term, Long term, Premature rupture of membrane, Pregnancy disorders
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0375148
Code Inist : 002B20F02. Création : 01/03/1996.