Original Article
Treatment of Preterm Labor with the Beta-Adrenergic Agonist Ritodrine
N Engl J Med 1992; 327:308-312July 30, 1992
- Abstract
- Abstract
Background.
Beta-adrenergic agonists are commonly used to arrest premature labor. Although treatment of preterm labor with these agents can delay delivery by 24 to 48 hours, the potential risks and benefits to the mother and infant before and after delivery have not been adequately assessed.
Methods.
We randomly assigned 708 women with preterm labor at six hospitals to receive an intravenous infusion of either the beta-adrenergic agonist ritodrine (n = 352) or placebo (n = 356). Assignment was made with stratification according to four categories of gestational age (20 to 23 weeks, 24 to 27 weeks, 28 to 31 weeks, and 32 to 35 weeks). The primary objective was to assess the effect of ritodrine on perinatal mortality. Secondary objectives were the evaluation of the causes of perinatal death, the extent to which delivery was delayed with ritodrine, and the effects on birth weight, maternal morbidity, neonatal morbidity, and infant morbidity at 18 months of postnatal age, corrected for preterm delivery.
Results.
Among the 771 infants born to the women in the study (including 63 pairs of twins), there were 23 deaths (6.1 percent) in the ritodrine group and 25 deaths (6.4 percent) in the placebo group (event-rate difference, -0.3 percent; 95 percent confidence interval, -3.7 percent to 3.1 percent). There was no difference between the groups in the extent of delay of delivery, the incidence of delivery before 37 weeks' gestation, the proportion of babies weighing less than 2500 g, or measures of neonatal morbidity. Maternal morbidity (such as chest pain and cardiac arrhythmias) occurred more frequently but not exclusively in the ritodrine group. One infant born to a woman in the ritodrine group and five infants born to women in the placebo group had cerebral palsy (P = 0.09). There was a slight but not significant trend toward an improved score on the Bayley Psychomotor Development Index at 18 months of age among the infants of the ritodrine-treated women.
Conclusions.
We found that the use of ritodrine in the treatment of preterm labor had no significant beneficial effect on perinatal mortality, the frequency of prolongation of pregnancy to term, or birth weight. (N Engl J Med 1992;327:308–12.)
Media in This Article
Table 1
Characteristics of the Study Population at Randomization, According to Treatment Group.Table 2
Characteristics of Treatment in the Ritodrine and Placebo Groups.Article Activity
- Article
PHARMACOLOGIC inhibition of preterm uterine activity with beta-adrenergic agonists has been used extensively in the past 20 years to arrest premature labor.1 It has been assumed that the use of these agents reduces perinatal mortality and the frequency of long-term handicaps by reducing the rate of prematurity.2 3 4 5 6 7 To date, however, there is limited evidence to substantiate this belief.8 , 9
In a recent meta-analysis,10 King et al. reviewed 16 controlled trials in which tocolytic agents, chiefly ritodrine, a relatively specific beta2-adrenergic agonist,1 were evaluated. Beta-adrenergic agonists were found to be effective in reducing the proportion of women who delivered within 24 hours and within 48 hours of treatment. There was little evidence, however, that such treatment decreased the likelihood of preterm delivery or reduced the risk of low birth weight (<2500 g). No single previous trial had a sample size sufficient for the assessment of perinatal mortality. Little information is available about either maternal or neonatal morbidity or the condition of the surviving infants at follow-up.
The primary objective of our trial was to assess the effect on perinatal mortality of using ritodrine to treat preterm labor. Secondary objectives were to determine the causes of perinatal death, the extent of delay of delivery, and the effects on birth weight and gestational age at delivery, maternal and neonatal morbidity, and infant morbidity at 18 months' postnatal age (corrected for gestational age at delivery).
Methods
In this randomized, controlled, multicenter trial, we compared the use of ritodrine with that of placebo administered blindly but otherwise under ordinary clinical conditions. Six university hospitals in Canada agreed to participate in the study.
Study Population
Women who had preterm labor and were considered in danger of delivering prematurely were eligible for the trial if the estimated gestational age of the fetus was 20 to 35 weeks (based on a reliable menstrual history, the date of the last menstrual period, the results of an early pregnancy test, or an ultrasound examination before 20 weeks). Threatened preterm delivery was defined as the presence of regular uterine contractions (four per 20 minutes or six per 60 minutes) documented by external tocography, or any uterine activity with either ruptured membranes or a cervix effaced by at least 50 percent or dilated by 2 cm or more. The presence of any of the following excluded the patient from the study: suspected chorioamnionitis, fetal distress, serious vaginal bleeding, severe preeclampsia, any condition necessitating immediate delivery, suspicion that the fetus was lethally malformed or dead, or any contraindication to the use of a beta-agonist drug in the mother, such as hypovolemia, cardiovascular disease (including pulmonary hypertension and arrhythmias), hyperthyroidism, uncontrolled diabetes mellitus, and asthma. The presence of ruptured membranes and previous or current use of glucocorticoids were not grounds for exclusion.
The protocol, study design, and consent forms were reviewed and approved by the research and ethics committees of each institution. After giving informed consent, women were randomly assigned to treatment groups, with stratification for gestational age (Table 1Table 1
Characteristics of the Study Population at Randomization, According to Treatment Group.). Randomization was carried out separately for each gestational-age group and at each center by a pharmacist. Patients, physicians, and nurses were blinded to the women's treatment allocation. Enrollment began in December 1985 and ended in October 1988. Eighteen-month follow-up evaluations of the surviving infants were completed in June 1990.Treatment Protocol
An intravenous infusion of 500 ml of 5 percent dextrose in water was administered over a period of 30 minutes. The rate of infusion of ritodrine (Yutopar, Bristol-Myers Canada and Philips—Duphar) or placebo (the dextrose solution alone) was adjusted every 20 minutes from 10 to 70 ml per hour (maximal ritodrine-infusion rate, 0.35 mg per minute) until the cessation of uterine activity, the failure of therapy, or the occurrence of unacceptable maternal side effects (such as tachycardia ≥130 beats per minute, hypotension with a systolic pressure ≤90 mm Hg, or chest pain). The effective dose was maintained for at least six hours after the cessation of regular uterine contractions; the dose was then progressively decreased until the infusion was ended.
If uterine contractions stopped, up to 12 tablets a day of oral medication (either 10 mg of ritodrine or a placebo of equivalent appearance) for five days were provided to each woman, while she remained hospitalized or at discharge, at the discretion of her physician. If the contractions began again, the woman was readmitted and treated intravenously again, using the previously assigned study medication. There was no crossover to the other therapy in the case of failure of treatment. After the completion of the study medication, each pregnancy was allowed to continue without further intervention. All outcomes were ascertained by personnel blinded to the women's treatment assignment. Data were collected by a research nurse before and during treatment, at labor and delivery, and post partum.
At a corrected postnatal age of 18 months, 50 percent of the surviving infants born to the women in the two study groups were selected randomly for a follow-up examination by a pediatrician and a psychologist. These follow-up examinations included a health history, a physical examination, and the administration of the Bayley Scales of Infant Development,11 a questionnaire for parents, and the Minnesota Child Development Inventory.12
Statistical Analysis
The statistical significance of the difference between the two groups in the incidence of fetal and infant death (the primary outcome measure) was tested with the MantelHaenszel chi-square test, taking into account each center's contribution to the outcome. Chi-square tests for statistical significance were conducted for the following secondary outcomes: the proportion of women delivering within 24 hours of treatment, within 48 hours, and before 37 weeks' gestation and the proportion of infants with cerebral palsy at follow-up. The alpha level for statistical significance was adjusted for multiple tests by means of the Bonferroni correction,13 with alpha set at 0.01. All P values are two-tailed.
For the other secondary outcomes, including measures of maternal and neonatal morbidity and the status of the infants at follow-up, the data were analyzed descriptively with use of 95 percent confidence intervals for the differences between the groups. Descriptive statistics were used to assess the comparability of the groups at enrollment. Confounding variables were compared between the groups to check for imbalance.
Results
Enrollment
Among the 4792 women who presented with threatened preterm delivery at the six centers during the study period, 2354 (49.1 percent) were ineligible: 25 percent of these (n = 577) because delivery was imminent, 34 percent (n = 796) because they met the criteria for exclusion, and the remaining 41 percent (n = 981) because they had no uterine contractions or inadequate contractions.
Of the 2438 eligible patients, 708 (29 percent) were enrolled and randomly assigned to treatment groups. Among the eligible women who were not enrolled, the physician declined to participate in 69 percent of the cases, the woman declined in 27 percent, and 4 percent were missed by study personnel. The reasons for nonparticipation given by the physicians included advanced gestation (43 percent), antepartum hemorrhage (25 percent), preference for another form of tocolysis (15 percent), and unspecified reasons (17 percent). The patients who declined cited a preference for no medication (40 percent), insistence on beta-agonist treatment (27 percent), or other reasons (33 percent).
Characteristics of the Study Population
Of the 708 women with threatened preterm delivery, 352 were assigned to receive ritodrine and 356 to receive placebo (Table 1). The infants born to these women included 63 pairs of twins, for a total of 771 infants (380 born to women in the ritodrine group and 391 to women in the placebo group). The mean age of the mothers was similar in the two groups. The median gestational age at enrollment was 31 weeks for both groups. The proportion of women completing glucocorticoid treatment was 34.6 percent in the ritodrine group and 36.0 percent in the placebo group.
Treatment
Among the enrolled women, five (0.7 percent) did not receive the intravenous therapy assigned because of the rapid progress of labor (Table 2Table 2
Characteristics of Treatment in the Ritodrine and Placebo Groups.). In both groups, early termination of intravenous therapy occurred mainly because of progressive cervical dilation, imminent delivery, or maternal side effects. Oral therapy was most often terminated because of imminent delivery or side effects. All the enrolled patients were included in the analysis.Outcomes
Delay of Delivery and Birth Weight
The proportions of women who delivered within 24 hours and within 48 hours were lower in the ritodrine group (P<0.001) (Table 3Table 3
Length of Time between Randomization and Delivery and Frequency of Preterm Delivery.). Although there was a nonsignificant difference between the groups in the proportion who delivered before 32 weeks' gestation, there was no difference in the proportion who delivered before 37 weeks. The mean (±SE) length of time from randomization to delivery was 27.8±1.6 days for the women in the ritodrine group and 24.5±1.6 days for those in the placebo group. The mean gestational age at delivery was 238 days (34.0±1.7 weeks) in the ritodrine group and 234 days (33.4±1.8 weeks) in the placebo group.The proportion of infants weighing less than 2500 g at birth was 55.9 percent in the ritodrine group and 61.8 percent in the placebo group. The mean birth weights were 2317±48 g in the ritodrine group and 2200±49 g in the placebo group.
Mortality
There were no maternal deaths. There were 48 deaths among the 771 infants (Table 4Table 4
Frequency of Stillbirth and Infant Deaths According to Gestational Age at Randomization, Time of Death, and Cause of Death.), including 21 stillbirths (10 in the ritodrine group and 11 in the placebo group). Seven stillborn infants in each group weighed less than 500 g. Of the remaining 27 deaths, 19 occurred during the first week, 5 occurred from day 8 through day 28 (late neonatal deaths), and 3 occurred after 28 days (postneonatal deaths). The total mortality rate was 6.1 percent in the ritodrine group and 6.4 percent in the placebo group (event-rate difference, -0.3 percent; 95 percent confidence interval, -3.7 percent to 3.1 percent).In three of the gestational-age strata, the mortality rates were similar in both groups. Among fetuses whose mothers were randomly assigned to study groups at 24 to 27 weeks' gestation, however, there was a trend toward a lower infant mortality in the ritodrine group than in the placebo group (11.5 percent vs. 18.7 percent; difference, -7.2 percent; 95 percent confidence interval for the difference, -19.1 to 4.7 percent).
The causes of death were similarly distributed in the two groups (Table 4). The most important cause was extreme immaturity, which accounted for nearly 40 percent of the deaths. The second most common causes were hyaline membrane disease and other respiratory complications, followed by major congenital anomalies.
We identified 18 potentially confounding variables that could have influenced the risk of death. These variables were distributed similarly in the treatment groups. They included antepartum bleeding, transfer of the mother from another hospital to one of the participating hospitals, previous tocolytic therapy, parity, the sex of the newborn, the infant's Apgar score, the status of cervix and membranes at enrollment and withdrawal, and glucocorticoid treatment.
Maternal Morbidity
Pulmonary edema developed in one ritrodrine-treated patient with undiagnosed mitral stenosis (Table 5Table 5
Maternal and Neonatal Morbidity According to Treatment Group.). Unacceptable side effects such as chest pain and cardiac arrhythmias occurred more often, although not exclusively, among the women treated with ritodrine than among those who received placebo. Other side effects, such as palpitations, dyspnea, nausea, vomiting, tremor, headaches, nasal stuffiness, hyperglycemia, and hypokalemia, also occurred more often, but not exclusively, among women receiving ritodrine (Table 5).Neonatal Morbidity
The diseases of major interest in this study were respiratory distress (of which hyaline membrane disease was the most frequent type), patent ductus arteriosus, intraventricular hemorrhage, infection, seizures, hypotension, and hypoglycemia. The incidence of these conditions was similar in the two groups (Table 5). The need for neonatal treatment, including resuscitation in the delivery room, blood-volume expansion, treatment for hypoglycemia, and phototherapy, was similar in both groups (Table 5).
The infants in each group spent a median of seven days in the hospital. Among the infants admitted to a special care nursery, the median length of stay in the special care nursery was 14 days in the ritodrine group and 17 days in the placebo group; the total length of the hospital stay for these infants was 21 and 23 days, respectively.
Status of Infants at the Follow-up Evaluation
At a corrected postnatal age of 18 months, the 246 children born to women in the two groups who were randomly selected to return for follow-up evaluations had similar scores on the Bayley Psychomotor Development Index (ritodrine, 110.9±16.8; placebo, 108.7±15.5). The average score on the Bayley Mental Development Index was 100.3±18.3 in the ritodrine group and 95.1±18.8 in the placebo group (Table 6Table 6
Findings on Follow-up Evaluation at 18 Months' Adjusted Age.*).Cerebral palsy diagnosed at 18 months was observed in one child whose mother was treated with ritodrine and in five children in the placebo group (P = 0.09). Only one child with cerebral palsy had a gestational age of less than 28 weeks at the time of the mother's enrollment.
Discussion
Treatment of preterm labor with the beta-adrenergic agonist ritodrine had no beneficial effect on fetal or neonatal mortality or on the incidence of preterm delivery (<37 weeks' gestation) in this trial. The most striking effect of ritodrine was to reduce the incidence of delivery within 48 hours after the treatment.
These results are generally in accordance with the conclusions of the overview of previous trials of treatment of preterm labor with beta-adrenergic agonists,10 most of which tested ritodrine. It is now quite certain, in the light of accumulated evidence, including data from this trial, that treatment with a beta-adrenergic agonist significantly reduces the rate of delivery within 48 hours, but that this immediate effect has not led to clinically important reductions in the rates of preterm delivery or low birth weight. Most important, the weight of accumulated evidence from randomized trials shows that treatment with a beta-adrenergic agonist has no significant effect on the rates of severe respiratory distress syndrome or perinatal death.
Because the principal effect of beta-adrenergic agonists is to delay delivery for a few days, it is important to do something useful during the time gained. Despite the reduction in the proportion of women who delivered within 48 hours in the ritodrine group in this trial, no difference was observed between the ritodrine and placebo groups in the proportion who completed a course of glucocorticoid treatment. Since the use of glucocorticoids during preterm labor has been shown in randomized trials14 to decrease neonatal mortality, it is probable that more liberal use of glucocorticoids, in conjunction with tocolytic treatment that is effective in delaying delivery for 48 hours, might have substantial benefit.
It is also important that trials be conducted to determine the effects of other interventions that might effectively use the time gained to improve perinatal outcome. For example, all participants in this trial had already been admitted to a tertiary care center at the time of randomization. Thus, future trials might investigate the role of ritodrine or other tocolytic agents in improving perinatal outcome by facilitating the transfer of a woman who is in danger of delivering prematurely to a tertiary care center.
Maternal morbidity increased with the use of ritodrine in all gestational-age groups. However, it was only among the women whose pregnancies were least advanced that we observed trends favoring ritodrine treatment in this trial, in the form of a lower mortality rate among infants whose mothers were randomly assigned at 24 to 27 weeks and were given ritodrine and a lower rate of very early delivery (<32 weeks' gestation) among these women. These observations suggest that the value of ritodrine is greater before 28 weeks' gestation than closer to term. In future trials it might be worthwhile to test the hypothesis that ritodrine treatment at gestational ages below 28 weeks may reduce fetal and neonatal mortality at an acceptable cost in terms of maternal morbidity. We do not recommend the use of ritodrine at gestational ages above 28 weeks unless it is administered to allow the mother to receive a full course of glucocorticoid treatment or to allow the evaluation of other uses of the time gained before delivery.
Address reprint requests to Dr. Jean-Marie Moutquin at the Department of Obstetrics and Gynecology, Saint-François d'Assise Hospital, 10 de L'Espinay St., Quebec City, QC G1L 3L5, Canada.
Supported by grants (SP 12 and UI 19) from the Canadian Medical Research Council.
*The members of the Canadian Preterm Labor Investigators Group are listed in the Appendix.
Appendix
The members of the Canadian Preterm Labor Investigators Group are as follows: Trial investigators: J.-M. Moutquin, Department of Obstetrics and Gynecology, Laval University, Quebec, Que.; S.B. Eifer, Department of Obstetrics and Gynecology, University of British Columbia, Vancouver; R.A. Milner, Department of Health Care and Epidemiology, University of British Columbia; P.T. Mohide, Department of Obstetrics and Gynecology, McMaster University, Hamilton, Ont.; R.S. Sauve, Department of Pediatrics, University of Calgary, Calgary, Alta.; J.C. Sinclair, Department of Pediatrics, McMaster University; C. Rand and L. Westfall, Department of Clinical Epidemiology and Biostatistics, McMaster University; Investigators at the study centers: Grace and B.C. Children's Hospitals, Vancouver, B.C. — M. Whitfield, P. Jansen, and Q. Jang; Ottawa Civic Hospital, Ottawa, Ont. — M.E. D'Alton, M. Hardie, D. Dudley, J. Belcher, S. Parnes, M.S. Dube, and M. Yen; McMaster University — D. Hunter, S. Saigal, V. Hunter, and D. Rosenbloom; Ottawa General Hospital, Ottawa, Ont. — N. Demianczuk, A. Cornet, S. Parnes, M. Dube, and M. Tierney; Grace Maternity Hospital, Halifax, N.S. — M. Vincer, C.G. Nwaesei, P. Zimmer, and M. Reno; and University of Alberta Hospital, Edmonton, Alta. — B.F. Mitchell, C. Robertson, and V. Phelan.
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