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PubMed1992

Oral magnesium and the prevention of preterm labor in a high-risk group of patients.

OBJECTIVE: The null hypothesis of this study is that treatment with oral magnesium gluconate 1 gm four times daily will not decrease the rate of preterm labor and delivery in a high-risk group of pregnant women. STUDY DESIGN: Fifty-four women at risk for preterm delivery were selected randomly to receive magnesium gluconate 1 gm orally four times daily or placebo. These women were monitored prospectively for signs and symptoms of preterm labor. A subgroup of 31 women also received a home uterine activity monitor. The serum magnesium level was measured initially and again 2 weeks after study enrollment. The data were analyzed with Fisher's exact test and analysis of variance. RESULTS: Preterm labor developed in 15 women in the placebo group and in 16 women in the magnesium group. There were no differences in birth weight or gestational age at delivery. The mean increase in serum magnesium level while the patients were taking magnesium gluconate was 0.10 mg/dl (p = not significant). Five women did not have an increase in serum magnesium level and preterm labor developed in all of them. CONCLUSION: Magnesium gluconate in a dose of 1 gm four times daily is not effective for preventing preterm delivery in a high-risk group of patients.

Administration, Oral↗
PubMed2001

Failure of cervical fibronectin to predict premature delivery in a population of monofetal pregnancies with idiopathic preterm labor.

OBJECTIVE: The purpose of the study was to evaluate the correlation between the presence of cervical fibronectin in a high-risk population of women with symptoms of preterm labor and the occurrence of preterm delivery or the need for aggressive tocolysis. STUDY DESIGN: One hundred and thirty women presenting with symptoms of threatened preterm labor were included. Cervical sampling for detection of fibronectin was performed on admission and every day until discharge or delivery. Time to delivery, length of hospital stay, use of indomethacin, delivery before 37 weeks of GA, mean term of delivery and failure of tocolysis to prevent delivery were compared to fibronectin test results. Data were analyzed using Student's t-test for continuous variables and the chi(2) test or Fisher exact test for discrete variables. RESULTS: No correlation could be found between the results of fibronectin cervical sampling on admission and any of the outcome parameters studied. Test performances were low (sensitivity 28%, specificity 57%, positive predictive value 19%, negative predictive value 69%). Results were not modified when the findings of repeated tests were taken into account. CONCLUSION: Cervical fibronectin failed to discriminate a subgroup of symptomatic women delivering prematurely. The prognostic value of fibronectin testing was not better than clinical data in our series. This observation is in disagreement with previous studies on the diagnostic value of vaginal or cervical fibronectin in preterm labor.

Cervix Uteri↗
PubMed2006

Dynamic cervical change: is real-time sonographic cervical shortening predictive of preterm delivery in patients with symptoms of preterm labor?

OBJECTIVES: To determine prospectively if dynamic cervical change (spontaneous real-time cervical shortening) is predictive of preterm delivery at < 37 weeks' gestation in patients with symptoms of preterm labor. METHODS: This was a prospective study of patients at 23-34 weeks' gestation who were symptomatic for preterm labor. Patients underwent a 10-min real-time sonographic cervical length assessment with measurements taken at 1-min intervals. The presence or absence of dynamic cervical change, defined as real-time changes in cervical length observable to the naked eye of the sonologist during the examination, was recorded. Gestational age at delivery was obtained from medical records. Preterm delivery was defined as delivery at < 37 weeks' gestation. Dynamic cervical change and initial and minimum cervical lengths were assessed for prediction of preterm delivery. RESULTS: Seventy-six patients were enrolled, and 66 were available for outcome analysis. Thirty-one patients (47%) exhibited dynamic cervical change. Patients with dynamic change had shorter initial cervical lengths (27 mm vs. 36 mm, P = 0.001), shorter minimum cervical lengths (20 vs. 33 mm, P < 0.001) and larger changes in cervical length during the examination period (10 vs. 4 mm, P < 0.001). In the subgroup of patients with an initial cervical length > 30 mm, those with dynamic change delivered earlier than did those without dynamic change (36.8 vs. 38.6 weeks, P = 0.02), and a higher percentage delivered preterm (27% vs. 11%, odds ratio (OR), 3.0 (0.5-17.0)). Multivariate analysis showed that minimum cervical length was a better predictor of preterm delivery than was initial cervical length. CONCLUSIONS: Dynamic cervical change occurs frequently in association with shortened cervical length. In patients with longer initial cervical lengths, dynamic change may increase the risk for preterm delivery. When dynamic change is noted in a patient with preterm labor symptoms, use of the minimum cervical length observed may be better compared with initial cervical length for determining preterm delivery risk.

Adult↗
PubMed1993

Efficacy and safety of nifedipine versus magnesium sulfate in the management of preterm labor: a randomized study.

OBJECTIVE: Our purpose was to establish the efficacy and safety of nifedipine versus magnesium sulfate in arresting preterm labor and the efficacy of nifedipine versus terbutaline in preventing recurrent labor. STUDY DESIGN: Singleton pregnancies at < 34 weeks in preterm labor were randomized to either oral nifedipine or intravenous magnesium sulfate. In case of tocolysis failure ritodrine was added. After labor was arrested, the patients in the nifedipine group were maintained on oral nifedipine, and those in the magnesium sulfate group were treated with oral terbutaline until completing 34 weeks. RESULTS: Of 100 patients 80 were considered eligible, of whom 39 were randomized to the nifedipine group. Both groups were comparable in terms of a number of entry variables, including cervical examination, contraction frequency, and gestational age. Both drugs were equally effective in arresting labor and delaying delivery > 48 hours, 92% versus 93%. Both study groups had a similar incidence of side effects, although four (10%) of magnesium sulfate-treated patients required drug discontinuation because of severe symptoms. Nifedipine was as effective as terbutaline in preventing recurrent labor, 26% versus 24%, and in achieving a gestation > 34 weeks, 62% versus 68%. CONCLUSIONS: Oral nifedipine is as effective as magnesium sulfate and terbutaline in arresting and preventing idiopathic preterm labor.

Administration, Oral↗
PubMed1998

Treatment of preterm labor with the oxytocin and vasopressin antagonist Atosiban.

Oxytocin is involved in the regulation of preterm and term labor but the exact effect mechanisms are not fully understood. A regulatory action by vasopressin may also exist. The concentrations of oxytocin and vasopressin V1a receptors in myometrium from pregnant women are high before and in the beginning of labor both preterm and at term. Atosiban has high affinity for both these receptors and is a competitive oxytocin and vasopressin antagonist. The inhibitory effect of Atosiban on oxytocin induced activity on isolated myometrium correlates significantly with the concentration of the oxytocin receptors. Inhibition of preterm contractions with Atosiban was first reported by Akerlund et al 1987. Goodwin et al compared the effect of Atosiban to placebo in threatening preterm labor and the antagonist was in this trial significantly more effective than placebo in reducing the frequency of contractions (55% vs. 23%, p < 0.001). The same authors also reported successful tocolysis with the drug in actual preterm labor. Atosiban is currently in phase III of clinical development and seems to have the same effectiveness but fewer side-effects compared to beta-mimetics. These properties suggests that Atosiban may offer advantages over existing therapies in acute treatment of preterm labor.

Female↗
PubMedDate not supplied

Erythromycin treatment for subclinical Ureaplasma urealyticum infection in preterm labor.

This study was undertaken to test the effects of erythromycin as an adjunct to tocolysis for preterm labor in women with vaginal cultures positive for Ureaplasma urealyticum. The study group consisted of 18 women in active preterm labor with pregnancies between 26 and 34 weeks of gestation and intact membranes who received 500 mg erythromycin orally every 8 h for 10 days. Seventeen women with similar characteristics served as controls and received no antibiotics. In all women contractions were suppressed with ritodrine. Erythromycin treatment resulted in a statistically significant greater mean delay of delivery (36.4 days) than among the control group (23.1 days). Higher proportion of term pregnancies (7 versus 3 pregnancies), higher mean birth weight (2,745 versus 2,474 g), lower neonatal morbidity (22.2 versus 42.2%) and shorter mean neonatal hospitalization time (9.6 versus 12.1 days) were observed, although these differences were not statistically significant. Adjunctive erythromycin treatment given to women treated for preterm labor with intact membranes and positive vaginal cultures for U. urealyticum appears to prolong gestation and to improve perinatal outcome.

Administration, Oral↗
PubMed1995

Fetal fibronectin, interleukin-6, and C-reactive protein are useful in establishing prognostic subcategories of idiopathic preterm labor.

OBJECTIVE: Our purpose was to evaluate fetal fibronectin, interleukin-6, and C-reactive protein from patients with preterm labor to establish prognostic subcategories. STUDY DESIGN: Thirty-seven patients with preterm labor had cervical fetal fibronectin and plasma C-reactive protein sampled. Eighteen of these patients had amniotic fluid interleukin-6 levels measured. Outcome variables were (1) delivery before 34 weeks and (2) delivery within 48 hours. RESULTS: Detectable cervical fetal fibronectin identified 89% of patients who were delivered before 34 weeks' gestation. Interleukin-6 > 1500 pg/ml identified 88% of patients who were delivered within 48 hours. C-reactive protein > 1.5 mg/dl correlated with elevated interleukin-6 levels (p < 0.001). CONCLUSIONS: Three subcategories of idiopathic preterm labor were evident: (1) fetal fibronectin nondetectable (37% likely to be delivered before 34 weeks), (2) fetal fibronectin detectable but interleukin-6 < 1500 pg/ml (79% likely to be delivered before 34 weeks but 85% with > 48 hours' latency), and (3) fetal fibronectin present and interleukin-6 > 1500 pg/ml (91% likely to be delivered with < 48 hours' latency).

Amniotic Fluid↗
PubMed1986

Adjunctive erythromycin treatment for idiopathic preterm labor: results of a randomized, double-blinded, placebo-controlled trial.

Pathogenesis and optimal treatment and prevention of preterm labor remain incompletely understood. Entry of cervical/vaginal microorganisms into lower uterine tissues has been implicated in preterm labor and may be amenable to specific therapy. Fifty-eight women with less than 34 completed weeks of gestation and without other obstetric complications, who were receiving intravenous tocolytics because of uterine contractions and who had cervical alteration (less than 5 cm dilated), were enrolled in a prospective randomized, double-blinded evaluation of 7 days of adjunctive therapy with enteric-coated erythromycin base (333 mg three times daily by mouth) versus placebo. Microbiologic examination included cultures for Neisseria gonorrhoeae, Chlamydia trachomatis, and group B streptococcus. Fifty-eight women with singleton pregnancies (29 erythromycin; 29 placebo) completed the protocol. Among women with cervical dilatation greater than or equal to 1 cm at the beginning of treatment, mean time until delivery was 32.5 days with erythromycin and 22.4 days with placebo treatment (p = 0.027). Of the erythromycin-treated women, seven of eight were delivered at greater than or equal to 37 weeks and only three of nine placebo-treated women were delivered at greater than or equal to 37 weeks (p = 0.035). Orally administered enteric-coated erythromycin as adjunctive treatment of pregnant women in labor less than or equal to 34 weeks is well tolerated. Adjunctive erythromycin given to women treated for preterm labor less than or equal to 34 weeks is associated with prolongation of pregnancy and delivery at 37 weeks only in women with cervical dilatation at the beginning of treatment.

Amniotic Fluid↗
PubMedDate not supplied

Clinical and cost-effectiveness of continuous subcutaneous terbutaline versus oral tocolytics for treatment of recurrent preterm labor in twin gestations.

OBJECTIVE: To compare the clinical and cost-effectiveness of treating recurrent preterm labor with continuous subcutaneous terbutaline versus oral tocolytics in twin gestations. STUDY DESIGN: In a retrospective, matched-cohort design, twin pregnancies treated as outpatients with continuous subcutaneous terbutaline were identified from a perinatal database, then matched 1:1 by gestational age at recurrent preterm labor to those receiving oral tocolytics. There were 353 patients per treatment group. A cost model was used to compare antepartum hospital, nursery, and outpatient charges. RESULTS: Infants of the subcutaneous terbutaline group had greater gestational age at delivery, higher birth weights, and less frequent neonatal intensive care unit admission. Charges for antepartum hospitalization and nursery were significantly less in the subcutaneous terbutaline group, while charges for outpatient services were less for the oral group. Mean total estimated charges were US$17,109 less for those receiving subcutaneous terbutaline. CONCLUSION: Improved clinical outcomes and decreased nursery utilization suggest cost-effectiveness of outpatient continuous subcutaneous terbutaline versus oral tocolytics for the treatment of recurrent preterm labor.

Administration, Oral↗
PubMed1998

Identification and case management in an HMO of patients at risk of preterm labor.

We carried out a study of pregnant patients in a health maintenance organization to identify and provide case management of women at risk of preterm labor and to determine important risk factors for preterm labor in a managed care population. Data were collected on 794 women who completed an initial prenatal care visit at HealthAmerica of Pittsburgh between July 15, 1994, and March 31, 1995, and delivered at a local Pittsburgh hospital. The patients were assessed during an initial call to schedule their first prenatal visit and also at the 8- to 15-week and 24- to 28-week prenatal visits. Patients scoring 10 or higher on the risk assessment form were referred to a nurse case manager who provided education and support. Results of a logistic regression analysis suggest that the risk assessment tool was effective in identifying women at risk for preterm labor. "Physical/stressful work", as assessed by the patient, history of a prior preterm birth, and multiple gestation were all statistically significant predictors of preterm birth. Further research is needed to confirm the finding that physical or stressful work is a significant predictor of preterm births and to determine which aspects of the work may increase the patient's risk. This study was based on 8 months of data; however, additional program implementation is needed to evaluate fully the potential long-term benefits of the program.

Case Management↗
PubMed1995

Fetal fibronectin improves the accuracy of diagnosis of preterm labor.

OBJECTIVE: Our purpose was to assess the utility of cervicovaginal expression of fetal fibronectin in the diagnosis of preterm labor. STUDY DESIGN: Women seen between 24 and 34 weeks' gestation with symptoms of preterm labor, intact membranes, and cervical dilatation < 3 cm were enrolled at five university medical centers. Cervicovaginal swabs were obtained and assayed for the presence of fetal fibronectin by means of a monoclonal antibody assay. Results were compared with cervical dilatation and uterine contraction frequency as indicators of interval to delivery and delivery before 37 weeks. RESULTS: A total of 192 eligible women at a mean gestational age of 30.8 +/- 2.9 weeks were enrolled from a population of 418 subjects screened. The rate of preterm birth was 32.3% (62/192). The mean interval from presentation to delivery was 25.3 +/- 24.1 days in the 45 subjects with a positive fibronectin assay and 52.4 +/- 24.8 days in the 147 subjects with a negative assay (p = 0.0001). The sensitivity, specificity, and positive and negative predictive values of fetal fibronectin expression for delivery < 37 weeks were 44% (27/62), 86% (112/130), 60% (27/45), and 76% (112/147). The fetal fibronectin assay was especially useful in predicting risk of delivery within 7 days (sensitivity 93% [13/14], specificity 82% [146/178], positive predictive value 29% [13/45], and negative predictive value 99% [146/147]) and was notably superior to both cervical dilatation > 1 cm and contraction frequency greater than or equal to eight per hour (sensitivities 29% and 42%, specificities 82% and 67%, positive predictive values 11% and 9%, and negative predictive values 94% and 94%, respectively. CONCLUSION: Cervicovaginal fetal fibronectin predicts delivery within 7 days more accurately than do cervical dilatation and contraction frequency in a population of women evaluated for early preterm labor.

Adult↗
PubMed2003

Matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in plasma/serum and urine of women during term and threatened preterm labor: a clinical approach.

OBJECTIVE: To explore the concentrations of matrix metalloproteinase-9 (MMP-9) and tissue inhibitor of metalloproteinase-1 (TIMP-1) in plasma, serum and urine of women during term and threatened preterm labor. METHODS: Plasma and urine proMMP-9 as well as serum and urine TIMP-1 were evaluated in 60 healthy pregnant women; 20 of them presented in term labor following an uncomplicated pregnancy, 20 of them presented with threatened preterm labor and intact membranes at 24-36 gestational weeks and 20 of them were at 24-40 gestational weeks with no evidence of uterine contractions or other pregnancy complications. Data were analyzed with non-parametric statistical tests and cut-off values were determined with receiver operator characteristic curves. RESULTS: ProMMP-9 values were significantly higher and TIMP-1 values were significantly lower in cases with uterine term or preterm contractions compared to non-labor status; and in cases with preterm contractions that progressed to true preterm labor compared to those in which contractions were arrested. CONCLUSIONS: Alterations in the concentrations of proMMP-9 and TIMP-1 can be detected in plasma or serum and urine of pregnant women experiencing term or preterm uterine contractions. The altered values of proMMP-9 and TIMP-1 could possibly identify the inevitable progress of preterm contractions to true preterm labor.

Adult↗
PubMedDate not supplied

Symptoms of preterm labor and self-diagnostic confusion.

The purpose of this study was to learn how women experiencing preterm labor come to know a health deviation exists, and what they do when faced with such a problem. Grounded theory methodology was used as the research approach. Extensive interviews were conducted with 28 women about their care-seeking experiences with preterm labor. Ambiguous symptoms, absence of a meaningful label to attach to symptoms, and the context of pregnancy with its expected discomforts come together to create a situation of diagnostic confusion. Appropriate action to take in response to the diagnostic confusion is not self-evident. Deliberate and protracted efforts to make sense of and deal with symptoms of preterm labor are attempted. Making sense consists of three subprocesses: comparing, gathering data, and seeking information. Strategies used to deal with the symptoms include self-treating, ignoring, positive thinking, and waiting. Recourse to a professional is used as the strategy of last resort when symptoms can no longer be contained.

Adolescent↗
PubMed2004

Impact of ultrasound cervical length assessment on duration of hospital stay in the clinical management of threatened preterm labor.

OBJECTIVE: To evaluate the impact of ultrasound cervical length measurement on duration of hospital stay in patients admitted for threatened preterm labor. STUDY DESIGN: This was a prospective, comparative study in 294 patients with threatened preterm labor in three hospitalization units (Units A, B and C). In the first phase of the study (observational), cervical length was measured by transvaginal ultrasound, but managing physicians were blinded to the results. In the second phase (interventional), physicians from Unit A remained blinded to cervical length information, but Units B and C incorporated these data into their clinical management protocols. Early discharge was contemplated if the cervix measured 25 mm or more on admission (Unit B) or no changes were observed over 48 h (Unit C). Duration of hospital stay and delivery rates within 7 days and before 37 weeks' gestation were recorded. RESULTS: Hospital stay was significantly reduced in Units B and C in the interventional phase, while no changes were observed in Unit A. Delivery rates within 7 days and before 37 weeks' gestation were similar in the three units during the two stages of the study. CONCLUSION: Routine use of ultrasound cervical length assessment in patients admitted with threatened preterm labor may reduce the duration of hospital stay without increasing the rate of preterm births. These data should be confirmed by means of an appropriately designed randomized clinical trial.

Adult↗
PubMed2004

Oral nifedipine maintenance therapy after acute intravenous tocolysis in preterm labor.

AIMS: Our aim was to evaluate the efficacy of maintenance oral nifedipine in pregnant women initially treated with intravenous ritodrine plus verapamil for preterm labor. METHODS: The study included 73 patients with preterm labor with intact membranes. Patients were randomized to receive either maintenance oral nifedipine therapy (n=37) administered 20 mg every six hours or no treatment (controls, n=36) after discontinuation of acute intravenous tocolysis. RESULTS: Compared to the control group, the mean +/- SD time gained from initiation of maintenance therapy to delivery (26.65 +/- 18.89 vs. 16.14 +/- 12.91 days, p=0.007) and the gestational age at delivery (37.03 +/- 2.06 vs. 35.1 +/- 3 weeks, p=0.003) were higher in the nifedipine maintenance therapy group. The proportion of patients who required one or more courses of subsequent intravenous therapy and perinatal outcomes were similar in the maintenance therapy and control groups. CONCLUSIONS: The gestational age and time gained from initiation of maintenance therapy to delivery were longer in women receiving oral maintenance tocolysis with nifedipine. However, maintenance therapy did not decrease the recurrence of preterm labor episodes or improve perinatal outcomes.

Administration, Oral↗
PubMed2005

Evaluation and validation of a new risk score (CLEOPATRA score) to predict the probability of premature delivery for patients with threatened preterm labor.

OBJECTIVE: To develop a clinically useful tool to predict the probability of preterm delivery in patients with threatened preterm labor. METHODS: One hundred and seventy patients with preterm labor between 24 and 34 weeks of gestation were included. Preterm delivery < 37 weeks of gestation was the main endpoint of the study. The data were randomized and split into an evaluation set (n = 85) and a validation set (n = 85). The evaluation set was subjected to stepwise backward logistic regression analysis to quantify the relative impact of four potential risk factors, including individual patient factors, results of a rapid fetal fibronectin assay, and sonographic measurement of cervical length. Using the constant of the logistic regression analysis and the beta-coefficients for the identified risk factors the individual probability of preterm delivery for each woman of the validation dataset was calculated. The area under a receiver-operating characteristics curve (AUC) was used to evaluate the discriminating power of the score. RESULTS: The overall rate of preterm delivery was 27.1%. The logistic regression analysis was performed for the potential predictors of spontaneous preterm delivery, identified by univariate analysis. These were positive fetal fibronectin, cervical length, previous preterm delivery and maternal age. Two risk factors were independent predictors of preterm delivery and were included in the CLEOPATRA I (clinical evaluation of preterm delivery and theoretical risk assessment) score: cervical length measurement and previous preterm delivery were associated with a higher risk of preterm delivery (odds ratio, 7.65 and 6.74, respectively). Since fetal fibronectin assay is not available at all institutions worldwide, it was excluded from the initial model. In the CLEOPATRA II model the risk factors fetal fibronectin and previous preterm delivery were associated with higher risk of preterm delivery, with odds ratios of 17.9 and 4.56, respectively. The discrimination power (AUC) obtained from the models were: CLEOPATRA I, 0.69 (95% CI, 0.56-0.82); CLEOPATRA II, 0.81 (95% CI, 0.69-0.93). CONCLUSION: In symptomatic women the risk for preterm delivery can be predicted best with the CLEOPATRA II score based on fetal fibronectin and previous preterm delivery.

Adult↗
PubMed2005

[Acute pulmonary edema during preterm labor: role of nicardipine tocolysis (three cases)].

Beta adrenergic agonists are still used as first line treatment for preterm labor in many institutions, but their side effects lead to use alternative tocolytic drugs such as calcium channel blockers. We report three cases of pulmonary edema during preterm labor associated with the use of calcium channel blocker, intravenous nicardipine, widely used for tocolysis in France. In this article, potential mechanisms of this severe complication are briefly discussed: pregnancy-induced overload, deleterious hemodynamic effects of calcium channel blockers, concomitant administration of calcium channel blockers and/or beta-agonists and finally concomitant administration of physiological saline and/or glucocorticoids. Based on our experience, we recommend avoiding the association of calcium channel blockers and beta-agonists for preterm labor. Nicardipine, if used, should be administered at an adjusted dose with electric syringe to reduce volume infusion.

Acute Disease↗
PubMed1995

A randomized, prospective study of adjunctive ceftizoxime in preterm labor.

OBJECTIVE: Our purpose was to determine the effect of ceftizoxime in the prolongation of pregnancies receiving tocolysis for preterm labor. STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial was conducted in patients with preterm labor between 24 and 35 weeks' gestation. A total of 545 patients with intact membranes and without chorioamnionitis who were receiving magnesium sulfate were screened. Exclusions were for advanced cervical dilatation, penicillin allergy, current antibiotic therapy, and failure to give informed consent. Of these, 117 consecutive, eligible, consenting patients were randomized to receive either 2 gm of ceftizoxime or a placebo every 8 hours. The primary end point was prolongation of gestation. Statistical comparisons were performed by use of unpaired two-tailed t tests and chi 2 analysis. RESULTS: Of the 58 ceftizoxime and 59 placebo patients, there was no difference in the interval to delivery (34.5 +/- 21.1 days vs 34.6 +/- 24.5 days, p = 0.99) and no difference in the rate of delivery before 37 weeks' gestation (60% in the ceftizoxime group vs 58% in the placebo group, p = 0.91). Subanalyses of 61 subjects who received nine or more doses and who were group B streptococci negative, 69 patients at < or = 32 weeks on presentation, and 22 sets of twins all showed no differences in delivery interval or rate of delivery at < 37 weeks. The sample size of this study was sufficient to detect a 9-day difference in prolongation of pregnancy (alpha = 0.05, beta = 0.2). CONCLUSIONS: Ceftizoxime had no effect on interval to delivery or duration of pregnancy in women treated for preterm labor.

Adolescent↗