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Page 1: 326 A Prospective Randomized Clinical Trial Comparing a New Oral Sustained Release Ritodrine Versus Conventional Ritoirine Tablets

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366 SPO Abstracts

PROSPECI'IVE EVAUJATION OF SYMPTOMS (Sx) PRECEDING PRETERM LABOR (PTL). I..!l..lma, M Parker", FF Johnson", The Ohio State University Department of Obstetrics & Gynecology, Columbus, OH.

The clinical utility of reported Sx in diagnosing PTL is controversial, based on studies of patient recall. No prospectively collected data about PTL symptomatology has been published. During a trial of an ambulatory contraction monitor, we collected information prospectively about several common Sx of PTL. Data were obtained by daily telephone contact with subjects at risk of preterm birth who had not had PTL in the current pregnancy. Fifty seven women developed PTL. Their answers to a standard battery of yes/no questions for the 7 days preceding their admission for parenteral tocolysis form the basis of this descriptive report. There is a 2 to 3 day period prior to PTL in which several common Sx, (self-detected contractions, vaginal discharge, menstrual cramps and backache), are seen to occur with increased frequency. These Sx are common in normal pregnancy, and are unlikely to be individually predictive of PTL. However, the persistence of these Sx, especially in combination, should prompt an office visit for cervical examination and uterine activity monitoring.

50

i : ~ 20

II' 10

~~::.!:::::;!~L...-...1...--7 -6 -5 -4 ·3 -2 -I

DAYS BERlRE PRE1ERM L-\BOR

--r- % Palp Ctxn --+- % Vag Dischg ---- % Backache --+- % Mens Cramp

-- %Presmne % Abd Cramps

325 PROLONGATION OF TWIN PREGNANCY WITH MAGNESIUM SULPHATE/SUBCUTANEOUS TERBUTALINE PUMP THERAPY IN THE FACE OF ADVANCED CERVICAL DILATATION AND EFFACEMENT, Robert N. Wolfson_ M.D.!Ph.D. Sandra K. Winnx

, B.S.N., R.N. Memorial Hospital, Colorado Springs, CO

The literature suggests that tocolytic efficacy is lost when there is advanced cervical dilatation and effacement. Since January, 1989 nine sets of twins have been treated in advanced preterm labor (cervical dilatation ~ 3 em. and cervical effacement ~ 80%) with aggressive acute magnesium sulphate tocolysis followed by subcutaneous terbutaJine pump therapy. On admission median cervical dilatation was 3.7 em. (range 3-5 cm.) Median cervical effacement was 90% (range 80-100%) and median gestational age was 31 weeks (range 27-34 weeks). All patients received 72 hours of magnesium sulphate tocolysis, median maximum magnesium maternal serum level 6.4 mg/dl (range 4.2-9.5 mg/dl) and were transitioned to subcutaneous terbutaline pump therapy, median basal infusion rate 0.106 mg/hr, (range 0.088-0.15 mg/hr). Median duration of pump therapy was 14 days, (range 12-29 days). All patients received betamethasone therapy for enhancement of fetal lung maturity and antibiotic prophylaxis for beta-hemolytic Strep. One patient delivered preterm after discontinuing therapy against medical advice. Of the remaining eight, six (75%) achieved either 37 weeks or mature lung indices on amniocentesis. The two preterm births occurred at 29 and 32 weeks gestation after 12 and 14 days of pump therapy respectively. We conclude from this preliminary experience that twin pregnancies complicated by advanced preterm labor can often be prolonged to fetal lung maturity through the use of subcutaneous terbutaline pump therapy.

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January 1992 Am J Obstet Gynecol

A PROSPECTIVE IlAllllJllIZED D.lllCAL TRIAL IXIIPARIIIG A lEV IIIAI. SllSTAIIIED RELEASE RITIIlRIIE VERSUS aJIIVEITlOIIAL RITIIlRIIE TABLETS Zion Hagar. M. EpsteinX, Z. GotlibX, C. Goldchmitx, I. Blickstein, A. MazkelX, V. Inslerx and E.A. Reece*, KapLan Hospital, Rehovet, Israel and *T"""le University School of Medicine, Phi ladelphia, PA

Oral conventional ritodrine (OCR) therapy requires nultiple daily doses_ A new sustained-release (SR) form of ritodrine was introduced which allows a reduction in the frequency of drug intake, Although, such may i..,rove c"""liance and efficacy it remains unknown whether this presuned benefit is at the expense of increase cardiovascular side effects_ MATERIALS AlllIlETIIIJ)S: All patients (mean GA: 30_7t3 weeks) admitted to the study had successful IV tocolysis_ Patients were randomly assigned to treatment that consisted of either 10 mg of OCR administered every 8 hours (80 mg/day) or one 40 mg SR capsule administered every eight hours (120 mg/day). The first oral treatment course lasted 5 days in each patient and then was switched to a second oral treatment course of the other drug for another 5 days. Every patient underwent non~inv8sive hemodynamic evaluation on days 4 and 9 of therapy_ RESULTS: In this ongoing clinical trial, 18 patients were studied_ Hemodynamic parameters assessed included: shortening fraction (SF), left ventricle ejection fraction (LV-EF), left atrial diameter (LAD), heart rate (HR) and changes in cardiac axis. Resul ts are presented in Table 1. ~ic Par_ter During OCR Therapy During SR Therapy

SF (m) LV-EF (X) LAD (m) HR (beats/m) Cardiac Axis (degree)

0_60 (±0.123) 67 (±9_08)

34_4 (±2.5) 108 (±19_2)

44_0 (±20.7)

0_55 (±0_125) 69 (± 5/47)

31.8 (±2.1) 104 (±10.2) 46 (±26.0)

* Statistical analysis, t-test for paired s"""les_ CDlCLUSIOll: This preliminary resul ts show no significant differences in maternal hemodynamic responses durins treatment with the new S_R_ form (120 ms/day) as conpared to conventional ritodrine therapy_

327 NlFEDIPINE VS, RITODRINE AS TOCOLYTIC AGENTS, Gustaaf A Dekker MD PhD', Karin van Dijk', and Herman P. van Geijn MD PhD' Dept. of Obstetrics, Free University Hospital, Amsterdam, The Netherlands

The effectiveness of ritodrine in the treatment of premature labour remains controversial. In most patients treated with ritodrine taChyphylaxis develops in 2-4 days probably because of homologous receptor regulation and/or induction of cyclic nucleotide phosphodiesterase activity. Nifedipine is effective as smooth muscle relaxant and at the same time has low toxicity and teratogenicity. In the current retrospective study the results of nifedipine (N = 33) in the treatment of premature labour were compared with a control group treated with ritodrine (N = 36). The 2 groups were comparable with regard to parity, age, and gestational age at initiation of therapy. Nifedipine was found to be considerably more succesful in halting labour than ritodrine. The average (± SD) prolongation of pregnancy was in the nifedipine treated women 36,3 days (SD 42,1) vs. 8.9 days (SD 15,2) in the women treated with ritodrin. In the ritodrine group all patients delivered before 34 weeks' gestation. In contrast in the nifedipine group delivery could be postponed till > 34 weeks' gestational age in 8 patients. Side effects with nifedipine were minimal, patients treated with ritodrine demonstrated well known side effects such as nausea, vomiting, palpitations and malaise. Treatment for a patent ductus arteriosus was needed in 18 neonates in the ritodrine group and in only 6 neonates in the nifedipine group. A prospec­tive study has been initiated to assess the definite clinical value of nifedipine as tocolytic agent.

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