Terbutaline Pump Research Articles

Terbutaline pump maintenance therapy after threatened preterm labour for reducing adverse neonatal outcomes.

After successful inhibition of threatened preterm labour women are at high risk of recurrent preterm labour. Terbutaline pump maintenance therapy has been used to reduce adverse neonatal outcomes. This review replaces an earlier Cochrane review, published in 2002, which is no longer being updated by the team. To determine the effectiveness of terbutaline pump maintenance therapy after threatened preterm labour in reducing adverse neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2014) and reference lists of retrieved studies. Randomised controlled trials comparing terbutaline pump therapy with alternative therapy, placebo, or no therapy after arrest of threatened preterm labour. Two review authors independently assessed the studies for inclusion and then extracted data as eligible for inclusion in qualitative and quantitative synthesis (meta-analysis). Four studies were included with a total of 234 women randomised. The overall methodological quality of the included studies was mixed; two studies provided very little information on study methods, there was high sample attrition in one study and in three studies the risk of performance bias was high. We found no strong evidence that terbutaline maintenance therapy offered any advantages over saline placebo or oral terbutaline maintenance therapy in reducing adverse neonatal outcomes by prolonging pregnancy among women with arrested preterm labour. The mean difference (MD) for gestational age at birth was -0.14 weeks (95% confidence interval (CI) -1.66 to 1.38) for terbutaline pump therapy compared with saline placebo pump for two trials combined. One trial reported a risk ratio (RR) of 1.17 (95% CI 0.79 to 1.73) for preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. We found no evidence that terbutaline pump therapy was associated with statistically significant reductions in infant respiratory distress syndrome, or neonatal intensive care unit admission compared with placebo. Compared with oral terbutaline, we found no evidence that pump therapy increased the rate of therapy continuation, or reduced the rate of infant complications or maternal hospital re-admissions. One study suggested that pump therapy resulted in significantly increased weekly cost/woman, $580 versus $12.50 (P < 0.01). No data were reported on long-term infant outcomes. We found no evidence that terbutaline pump maintenance therapy decreased adverse neonatal outcomes. Taken together with the lack of evidence of benefit, its substantial expense and the lack of information on the safety of the therapy do not support its use in the management of arrested preterm labour. Future use should only be in the context of well-conducted, adequately powered randomised controlled trials.

Subcutaneous Terbutaline Pump for Maintenance of Tocolysis following Arrest of Acute Preterm Labor.

Drs. Elliott and Morrison recently published a narrative review about the effectiveness of oral and subcutaneous maintenance of tocolytic agents following successful arrest of acute preterm labor [1]. The authors conclude that subcutaneous terbutaline pump is beneficial and safe for maintenance of tocolysis based on all the available evidence. While the authors have provided an exhaustive list of the 46 published studies that have examined the terbutaline pump, we would like to express some concerns about the interpretations of this evidence. The authors have formed conclusions without assessing study quality or synthesizing results. In addition, several of the studies cited are single-arm case series and we would be hesitant to draw any conclusions about the efficacy based on this weak study design. We were commissioned by the Agency for Healthcare Research and Quality to evaluate the benefits and harms of subcutaneous terbutaline pump for maintenance of tocolysis by conducting a systematic review of the literature [2, 3]. Using prespecified eligibility criteria, we included 14 unique studies [3–17]. The evidence base that we relied on to form our conclusions included all randomized and comparative observational studies. These studies have been cited by Drs. Elliott and Morrison. Of the remaining 33 studies cited by the authors, we had identified and excluded 29; primarily because these studies did not include a comparator group (i.e., they were single-arm studies). The 4 studies that were not identified by our search [18–21] would also have been excluded because there were no nonpump controls. These 14 studies were of lower quality (medium to high risk of bias) and several studies examined data from one proprietary database. Although we found that the pump was beneficial for some outcomes (i.e., neonatal death, incidence of delivery <32 weeks and <37 weeks, and prolonging pregnancy), importantly, these benefits were rated as having low strength of evidence, which means that we have low confidence that the evidence reflects the true effect [22]. The strength of evidence is a subjective—though systematic and transparent—assessment of the reviewers' confidence in the findings based on the overall risk of bias, inconsistency, indirectness, and imprecision of the body of evidence [22]. In addition, there was insufficient data on other clinically important outcomes, such as bronchopulmonary dysplasia, intraventricular hemorrhage, and neonatal and maternal harms. Our more cautious interpretation about the efficacy and safety of terbutaline pump is based on a systematic review of the evidence and scientific methods for quantitative and qualitative synthesis (i.e., meta-analysis and grading strength of evidence). While we acknowledge that the harms reported by FDA after marketing surveillance do not establish causality [23], we have shown that the evidence for efficacy has limited validity. As such, we maintain that the safety and efficacy of the pump for maintenance tocolysis are unclear. Its use should be limited to the research setting, such as further investigation in an adequately powered, randomized, controlled trial.

Current Resources for Evidence‐Based Practice January/February 2013

Current Resources for Evidence‐Based Practice January/February 2013

Effectiveness of terbutaline pump for the prevention of preterm birth. A systematic review and meta-analysis.

BackgroundSubcutaneous terbutaline (SQ terbutaline) infusion by pump is used in pregnant women as a prolonged (beyond 48–72 h) maintenance tocolytic following acute treatment of preterm contractions. The effectiveness and safety of this maintenance tocolysis have not been clearly established. We aimed to systematically evaluate the effectiveness and safety of subcutaneous (SQ) terbutaline infusion by pump for maintenance tocolysis.Methodology/Principal FindingsMEDLINE, EMBASE, CINAHL, the Cochrane Library, the Centre for Reviews and Dissemination databases, post-marketing surveillance data and grey literature were searched up to April 2011 for relevant experimental and observational studies.Two randomized trials, one nonrandomized trial, and 11 observational studies met inclusion criteria. Non-comparative studies were considered only for pump-related harms. We excluded case-reports but sought FDA summaries of post-marketing surveillance data. Non-English records without an English abstract were excluded. Evidence of low strength from observational studies with risk of bias favored SQ terbutaline pump for the outcomes of delivery at <32 and <37 weeks, mean days of pregnancy prolongation, and neonatal death. Observational studies of medium to high risk of bias also demonstrated benefit for other surrogate outcomes, such as birthweight and neonatal intensive care unit (NICU) admission. Several cases of maternal deaths and maternal cardiovascular events have been reported in patients receiving terbutaline tocolysis.Conclusions/SignificanceAlthough evidence suggests that pump therapy may be beneficial as maintenance tocolysis, our confidence in its validity and reproducibility is low, suggesting that its use should be limited to the research setting. Concerns regarding safety of therapy persist.

Terbutaline pump maintenance therapy after threatened preterm labor for preventing preterm birth.

Women with preterm labor that is arrested with tocolytic therapy are at increased risk of recurrent preterm labor. Terbutaline pump maintenance therapy has been given to such women to decrease the risk of recurrent preterm labor, preterm birth, and its consequences. To determine the effectiveness and safety of terbutaline pump maintenance therapy after threatened preterm labor in preventing preterm birth and its complications. We searched the Cochrane Pregnancy and Childbirth Group trials register (searched May 2002) and the Cochrane Controlled Trials Register (Cochrane Library Issue 2, 2002). Randomized trials comparing terbutaline pump maintenance therapy with alternative therapy, placebo, or no therapy after threatened preterm labor. Two reviewers independently assessed the studies for inclusion and then extracted data from eligible studies. We included two studies. Terbutaline pump maintenance therapy did not appear to offer any advantages over the saline placebo pump or oral terbutaline maintenance therapy in preventing preterm births by prolonging pregnancy or its complications among women with arrested preterm labor. The weighted mean difference (WMD) for gestational age at birth was -0.1 weeks (95% confidence interval (CI) -1.7 to 1.4) for terbutaline pump therapy compared with saline placebo pump for both trials combined and 1.4 weeks (95% CI -1.1 to 3.9) for terbutaline pump versus oral terbutaline therapy for the first trial. The second trial reported a relative risk (RR) of 1.17 (95% CI 0.79 to 1.73) of preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. Terbutaline pump therapy also did not result in a higher rate of therapy continuation or a lower rate of infant complications. No data were reported on long-term infant outcomes, costs, or maternal assessment of therapy. Terbutaline pump maintenance therapy has not been shown to decrease the risk of preterm birth by prolonging pregnancy. Furthermore, the lack of information on the safety of the therapy, as well as its substantial expense, argues against its role in the management of arrested preterm labor. Future use should only be in the context of well-conducted, adequately powered randomized controlled trials.

Terbutaline pump maintenance therapy for prevention of preterm delivery: A double-blind trial

Objective: This study’s aim was to determine whether maintenance therapy with terbutaline administered by pump prolongs gestation in women after treatment with intravenous magnesium sulfate tocolysis for suspected preterm labor. Study Design: Consenting women with a singleton gestation and intact membranes who had uterine contractions and >1 cm cervical dilation, 80% effacement, or progressive cervical change and whose contractions were successfully arrested with intravenous magnesium were randomly assigned to receive either terbutaline or normal saline solution placebo by subcutaneous infusion pump. Pump therapy was administered with a standardized protocol. Pump therapy was discontinued and parenteral magnesium was resumed if recurrent preterm labor developed while women were on the therapeutic regimen at <34 weeks’ gestation and no contraindication for tocolysis existed. If recurrent labor was arrested, pump therapy was restarted according to the original treatment group. A sample size of 48 women was required to detect a 2-week intergroup difference in mean time to delivery. Analyses were based on intent to treat. Results: Fifty-two women received terbutaline (n = 24) or placebo (n = 28). At random assignment the groups were similar with respect to age, race, parity, previous preterm delivery, gestational age, and cervical examination. Overall there was a 1-day difference in mean time to delivery between the groups (terbutaline 29 ± 22 days and placebo 28 ± 23 days, P = .78). There were no differences in the rates of preterm delivery at <34 and <37 weeks’ gestation. Neonatal outcomes were similar. Conclusions: Maintenance terbutaline therapy administered by pump does not prolong gestation in women successfully treated for suspected preterm labor. (Am J Obstet Gynecol 1998;179:874-8.)

Terbutaline Pump Tocolysis in High-Order Multiple Gestation

OBJECTIVE To review terbutaline pump tocolytic therapy as part of the management of high-order multiple gestations (triplet and quadruplet pregnancies). STUDY DESIGN We performed a retrospective review of the medical records of triplet and quadruplet pregnancies cared for by Phoenix Perinatal Associates from August 1988 to January 1992 in whom terbutaline pump tocolysis was administered. RESULTS The study group consisted of 15 triplet pregnancies and 6 quadruplet pregnancies. The 15 patients with triplets delivered at a mean (+/- SD) gestational age of 33.0 +/- 1.9 weeks. The six patients with quadruplets delivered at 33.0 +/- 1.3 weeks. Only 2 of 15 (13%) of the triplets and 1 of 6 (17%) of the quadruplets were delivered for tocolytic failure. CONCLUSION Terbutaline pump tocolysis provides safe and effective tocolytic therapy in a select group of high-order multifetal gestations.

A Placebo-Controlled Randomized Trial of the Terbutaline Pump for Prevention of Preterm Delivery

To determine the efficacy of the terbutaline pump for the prevention of preterm delivery, patients in preterm labor defined by progressive cervical change underwent intravenous magnesium sulfate tocolysis (with or without oral indomethacin, as necessary), and once labor was arrested, were randomized to one of three treatment arms: terbutaline by pump, saline by pump (blinded), or oral terbutaline. If recurrent preterm labor occurred despite maximization of therapy, the treatment arm was determined and therapy was changed; saline pump and oral terbutaline were switched to terbutaline pump, terbutaline pump was switched to oral terbutaline. Patients who continued to labor were readmitted for aggressive intravenous therapy. Women randomized to the terbutaline pump (n = 15), saline pump (n = 12), and oral terbutaline (n = 15) groups were similar in terms of gravidity, parity, days of tocolysis before study entry, gestational age at entry, and cervical dilatation at entry. The mean gestational age at delivery was the same in all three groups (35 weeks), as were neonatal outcomes. Terbutaline by pump, saline by pump, and oral terbutaline appear equivalent for the prevention of preterm delivery. The terbutaline pump should remain experimental.

Home infusion therapies for obstetric patients.

This article focuses on current indications for home intravenous therapy for the high-risk obstetric patient. Therapeutic indications and clinical care for obstetric patients in need of hydration/total parenteral nutrition, heparin infusion, terbutaline pump, and antibiotic therapies are presented.

522 Electrocardiographic Abnormalities with Subcutaneous Terbutaline Pump Therapy

522 Electrocardiographic Abnormalities with Subcutaneous Terbutaline Pump Therapy

Continuous subcutaneous terbutaline pump therapy for premature labor: safety and efficacy.

To assess the usefulness of a continuous subcutaneous pump infusion of terbutaline for long-term tocolysis, we used this modality in 13 patients in whom other tocolytic regimens had failed. The mean (+/- standard deviation) maternal age was 29.9 +/- 3.8 years. The study population included 10 singleton gestations, two sets of triplets, and one twin pregnancy. In three cases, the terbutaline pump was thought to have been successful (duration of pump therapy, 52.7 +/- 20.9 days; gestational age at delivery, 37.1 +/- 1.3 weeks), whereas in six cases marginal success was achieved (duration, 42.2 +/- 27.7 days; gestational age at delivery, 33.8 +/- 2.6 weeks). In the remaining four patients, pump therapy was discontinued after 2 to 23 days because of maternal complications. In contrast to previous reports, we achieved only limited success with the subcutaneous terbutaline pump in the small number of patients studied.

Maternal glucose intolerance and the subcutaneous terbutaline pump

Our hypothesis was that use of the subcutaneous terbutaline pump does not affect maternal glucose tolerance. With the 1-hour glucose tolerance test, we examined the incidence of glucose intolerance in 37 patients using the pump compared with that of 54 patients receiving oral terbutaline and 634 control subjects without risk factors for gestational diabetes. The frequency of gestational diabetes and the need for insulin to maintain glycemic control were subjected to chi 2 analysis. The incidence of gestational diabetes was 6% in the control subjects, 5% in patients using the pump (p = 0.8), and 11% in those on the oral therapy regimen (p = 0.4). A total of 8% of controls who had gestational diabetes required both insulin and diet, compared with 100% using the pump (p less than 0.01) and 50% on the oral terbutaline regimen (p = 0.03). The incidence of gestational diabetes is not increased in patients receiving terbutaline via the subcutaneous pump. The use of terbutaline by any route significantly increases the need for insulin to achieve glycemic control.

325 Prolongation of Twin Pregnancy with Magnesium Sulphate/Subcutaneous Terbutaline Pump Therapy in the Face of Advanced Cervical Dilatation and Effacement

325 Prolongation of Twin Pregnancy with Magnesium Sulphate/Subcutaneous Terbutaline Pump Therapy in the Face of Advanced Cervical Dilatation and Effacement

466 Quadruplet Pregnancy - Contemporary Management and Outcome

Quadruplets are occurring more frequently as assisted-reproduction techniques improve fertility in couples previously unable to conceive. Ten quadruplet pregnancies cared for in one perinatal practice over 5 years had excellent outcome. The mean gestational age at delivery was 32.5 weeks, compared with approximately 30 weeks in the literature. There were no perinatal deaths and no long-term morbidity. Our patients were compared with a series of 57 consecutive patients with quadruplet pregnancies monitored by a home monitoring system. Parity of 1 or more appeared to improve outcome. Pregnancy-induced hypertension occurred in nine of our pregnancies and necessitated delivery in seven instances. Fetal distress was responsible for two deliveries and uncontrollable preterm labor for only one. Key points in our management protocol include prophylactic use of low-dose aspirin, home contraction monitoring, use of terbutaline pump tocolysis, and bed rest at home starting at 16 weeks.

Comanagement of the patient on subcutaneous terbutaline pump therapy

The subcutaneous terbutaline pump is a new modality available for pharmacologic treatment of preterm labor. Because nurse-midwives may be involved in the care of women on this therapy, an overview of terbutaline pharmacology, pump development, and advantages versus disadvantages of this therapy is provided. Initiation of therapy in the appropriate patient is described. Outpatient therapy is the goal for these women, and the nurse-midwife may appropriately comanage this aspect of care. Guidelines are presented for physical and psychosocial care.

478 Use of the terbutaline pump is not associated with increased maternal glucose intolerance

478 Use of the terbutaline pump is not associated with increased maternal glucose intolerance

The Treatment of Preterm Labor Using a Portable Subcutaneous Terbutaline Pump

The perinatal mortality rate related to preterm delivery has led researchers to investigate new methods of tocolysis. A new concept in managing preterm labor uses continuous administration of terbutaline sulfate via a portable subcutaneous infusion pump. Use of the terbutaline pump to treat 13 preterm labor patients at the Baylor College of Medicine demonstrated an efficacy rate of 9 for a population failing all other methods of tocolysis. This unique treatment modality offers new hope for patients experiencing recalcitrant preterm labor.