Abstract :
Objective: The aim of this study was to compare the efficacy, safety, adverse effects and cost effectiveness of extra-amniotic Foleyʹs catheter balloon alone (group-I) with the combined use of Foleyʹs catheter balloon and extra-amniotic prostaglandin F2-alpha (group-II) for termination of second trimester pregnancy.Material and Methods: It was a comparative randomised trial carried out in obstetrics and gynaecology unit of Postgraduate Medical Institution, Lady Reading Hospital Peshawar, during 2002. Patients were randomly allocated to group-I, having odd admission numbers and group-II, having even admission numbers. Sixty-three patients having gestational age between 14 to 28 weeks and cervical score less than 4 were enrolled in the study, 33 for group-I and 30 for group-II. Indications for termination were either intra-uterine foetal death or congenital malformations incompatible with life. Both the groups had a size-16-F Foleyʹs catheter passed through the internal OS and its balloon distended with 30 millilitres of distilled water. Group-II patient in addition received extra-amniotic prostaglandin F2-alpha (0.25mg/ml diluted solution), one ml at hourly interval, through the same catheter, till the expulsion of the balloon.Results: Mean induction to products expulsion interval was significantly shorter in the combined use of Foleyʹs catheter balloon and extra-amniotic prostaglandin F2-alpha (PGF2-alpha)- compared to the use of Foleyʹs catheter balloon alone (16.50±8.823 versus 37.76±11.019 hours, P<0.005). The rate of successful uterine evacuation within 24 hours was also significantly higher in group-II (86.66% versus 6.06%, PcO.Ol). The incidence of vomiting (10%), diarrhoea (6.66 %) and uterine pain (10%) in group-II was not statistically significant (P>0.05), but the frequency of temperature of 100°F was significantly higher in group-I (23.64%) compared to group-II (3.33%). Group-II patient had shorter average hospital stay (1.533±0.57 versus 2.766±0.567 days, P<0.005) and lower mean hospital expenses (Rupees 1139.99±276.80 compared to 1383.33±284.16, P<0.05). Complete abortion rate was similar between the two groups.Conclusion: The combined use of Foleyʹs catheter balloon and extra-amniotic PGF2-alpha is more rapid, safe and cost effective method for induction of therapeutic termination of second trimester pregnancy, resulting in greater number of successful uterine evacuation within 24 hours, than the Foleyʹs catheter balloon alone.
Keywords :
Second trimester , pregnancy termination , Foleyיs catheter balloon , prostaglandin F2-alpha
