TEMPLATE DESIGN © MAINTENANCE NIFEDIPINE FOR TOCOLYSIS IN PRETERM LABOUR: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL Uma M, Ixora KA, Nor Azlin MI, ZA Mahdy Department of Obstetrics & Gynaecology, Universiti Kebangsaaan Malaysia Medical Centre (UKMMC) Objectives ResultsConclusions References 1. Lewis R. Oral terbutaline after parenteral tocolysis: A randomised, double-blind, placebo- controlled trial. American Journal of Obstetrics and Gynaecology 1996;175 (4): King JF, Flenady V, Papatsonis D et al. Calcium Channel Blockers for inhibiting preterm labour: A systematic review of the evidence and a protocol for administration of nifedipine. Aust and NZ Journal of Obstet and Gynaecol 2003; 43: Oei, SG, Mol BW, de Kleine MJ et al. Nifedipine versus ritodrine for suppression of preterm labor; a meta-analysis. Acta Obstet Gynecol Scand 1999; 78(9): Tsatsaris V, Papatsonis D, Goffinet F et al. Tocolysis with nifedipine or beta-adrenergic agonists: a meta-analysis. Obstet Gynecol 2001; 97(5 Pt 2): Ferguson JE, Dyson DC, Schutz T et al. A comparison of tocolysis with nifedipine or ritodrine: analysis of efficacy and maternal, fetal, and neonatal outcome. Am J Obstet Gynecol 1990; 163(1 Pt 1): Papatsonis DN, Van Geijn HP, Ader HJ et al. Nifedipine and ritodrine in the management of preterm labor: a randomized multicenter trial. Obstet Gynecol 1997; 90(2): Sanchez-Ramos L, Kaunitz AM, Gaudier FL et al. Efficacy of maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet Gynaecol 1999; 181(2): Conde-Agudelo A, Romero R, Kusanovic JP. Nifedipine in the management of preterm labour: a systematic review and metaanalysis. Am J Obstet Gyecol 2011; 204(2): 134 e Ixora KA, Nor Azlin MI, Ani Amelia Z et al. Terbutaline versus nifedipine in the management of preterm labour. Unpublished thesis for the Masters of Obstetrics and Gynaecology (UKM) 2007: Wigton TR, Tamura RK, Wickstrom E et al. Neonatal morbidity after preterm delivery in the presence of documented lung maturity. AmJ Obstet Gynecol 1993;169:951e Di Renzo GC, Giardina I, Rosati A et al. (the Italian Preterm Network Study Group). Maternal risk factors for preterm birth: a country-based population analysis. European Journal of Obstetrics & Gynecology and Reproductive Biology Oct 2011; 7482:1-5. Main objective 1.1. To compare incidence of preterm delivery less than 37 weeks in patients treated with or without maintenance nifedipine 1.2. To compare incidence of recurrent preterm contractions in patients treated with or without maintenance nifedipine Specific objective 2.1. To compare the latency period to delivery in both groups 2.2. To compare the maternal haemodynamics for both groups 2.3. To compare the neonatal outcome at delivery for both groups To compare the maternal side effects for both groups Inhibition of uterine contractility with tocolytic agents to prolong pregnancy and reduce neonatal complications continues to be the focus of treatment of preterm labour. The results of this randomized controlled study showed maintenance tocolysis with nifedipine up to 36 weeks was successful in prolonging gestation to 36.9 weeks as compared to 35.6 weeks with no treatment (A difference of 9 days). This may not be clinically significant as neonatal morbidity rates were less than 2% in neonates born at ≥34 weeks’gestation. 10 It was also not effective in preventing recurrent preterm contractions when compared with no treatment. This concurred with the systematic review by Conde-Agudelo 8 which showed no significant differences between nifedipine maintenance therapy and placebo or no treatment for preterm birth before 34 or 37 weeks gestation, episodes of recurrent preterm labour and adverse neonatal outcomes. In this study, Nifedipine was not associated with adverse effects and had no haemodynamic changes with long term use. Methods A prospective randomized controlled trial was conducted in UKMMC over a period of 20 months, between 1 st January 2010 to 30 th August 2011, with the approval of the Ethics Committee. A total of 98 women were admitted with preterm labour between weeks. All patients had the gestational age confirmed by their last menstrual period (LMP) or a dating scan. Exclusion criteria multiple pregnancies contraindication to nifedipine such as cardiovascular ds, hyperthyroidism, severe PE maternal/fetal indication for delivery – eg. Fetal distress contraindication for tocolysis, eg. PE, IUGR, fetal anomaly, chorioamnionitis, significant APH cervical dilatation of 3cm or more patients with previous tocolytic treatment during this pregnancy 49 women were randomly assigned to the treatment group and 49 women to the control group. The mean gestational age on admission was weeks in the control group and weeks in the treatment group. UTI and vaginal candidiasis are main causes of preterm labour. 30% had multiple causes contributing to preterm labour Deliveries and prolongation of pregnancy All women eligible for study, consent obtained Baseline Ix taken : ECG/FBC/BUSE/RBS levels/UFEME/HVS C&S All patients treated with nifedipine as per protocol for acute phase tocolysis Given IM dexa 12mg x 2 doses *Patients in nifedipine group given T. nifedipine 20mg tds till 36w upon discharge *patients in no treatment group was not given any medication after acute phase Pts with recurrent preterm contractions were given acute phase tocolysis once again & continued in the originally assigned group once the recurrent preterm contractions has subsided Randomised to maintenance nifedipine or no maintenance treatment group Group ControlTreatmentp-value Latency (days)No. (%) Delivery within 1 day10 (77%)3 (23%)0.052 Delivery after 1 to 7 days4 (57%)3 (43%)0.705 Delivery after 7 days35 (45%)43 (55%)0.365 Delivery Mean gestational age at delivery35.59 ± ± < 34 weeks11 (69%)5 (31%) weeks24 (51%)23 (49%)0.884 > 37 weeks14 (40%)21 (60%)0.237 * Chi-square test Group ControlTreatmentp-value Latency (days) for all patient (n=98)29.65 ± ± Latency (days) for gestation age ≤ 30weeks (n =14)49.10 ± ± Latency (days) for gestation age ≤ 32weeks (n =39)41.00 ± ± Latency (days) for gestation age ≤ 34weeks (n =90)31.25 ± ± * Independent T-test and chi-square test Latency (Days gained) Recurrent preterm labour Neonatal outcome Group ControlTreatmentp-value Gestation age at delivery35.59 ± ± Birth weight2.67 ± ± Cord pH7.29 ± ± Apgar score at 1 min8.29 ± ± Apgar score at 5 mins9.43 ± ± NICU admission(yes)13 (68%)6 (32%)0.108 * Independent T-test and chi-square test * No significant difference