Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery. Improved birth outcomes associated with enhanced Medicaid prenatal care in drug-using women infected with the human immunodeficiency virus. Cervicovaginal microflora and pregnancy outcome: results of a double-blind, placebo-controlled trial of erythromycin treatment. Randomized trial of antibiotics in addition to tocolytic therapy to treat preterm labor. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor. Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor. A randomized trial of nurse intervention to reduce preterm and low birth weight births. Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen. Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation.
To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.
                Multicentre, prospective, randomised controlled trial.
                Non-hospital based antenatal clinics.
                4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.
                The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.
                Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.
                Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women. To evaluate the effectiveness of an intervention designed to enhance Medicaid prenatal care in improving birth outcomes of drug-using women infected with the human immunodeficiency virus (HIV).
                Medicaid and vital statistics records were linked for 353 HIV-infected drug-using women delivering in 1993 and 1994 while enrolled in New York State Medicaid. Of these, 68% were treated by providers participating in the Prenatal Care Assistance Program, designed to provide case management, improved continuity, referral services, and behavioral risk reduction counseling. In a series of logistic models, we estimated adjusted odds ratios (ORs) and 95% confidence intervals (CIs) of low birth weight (less than 2500 g) and preterm delivery (before 37 weeks), comparing women using and not using the program.
                Women using the Prenatal Care Assistance Program were significantly less likely, after adjustments were made for maternal characteristics, to have low birth weight infants and preterm deliveries (OR 0.52, 95% CI 0.31, 0.89; and OR 0.57, 95% CI 0.34, 0.97, respectively). Adding measures of greater adequacy and continuity of prenatal care to the models explained just over 20% of the Prenatal Care Assistance Program's protective effect. The addition of maternal high-risk behavior, HIV-focused care, and drug use treatment variables altered program effect estimates less profoundly (together accounting for 4 and 9% of the program's protection against low birth weight and preterm delivery, respectively).
                The Prenatal Care Assistance Program appeared to be successful in reducing the incidence of low birth weight and preterm delivery in this high-risk population. The program's success can be attributed, in part, to increased adequacy and continuity of prenatal care and, to a lesser extent, to more frequent receipt of special services and reduced maternal high-risk behaviors. Available information suggests that some instances of preterm birth or premature rupture of membranes are associated with clinically unrecognized infection and inflammation of the lower uterine segment, decidua, and fetal membranes. Various cervicovaginal microorganisms have been recovered from these sites. Many of these microorganisms produce factors that may lead to weakening of the fetal membranes, release of prostaglandins, or both. This study evaluated the presence of various lower genital tract microflora and bacterial conditions in 229 women enrolled in a double-blind, placebo-controlled trial of short-course erythromycin treatment at 26 to 30 weeks' gestation to prevent preterm birth. Demographic, obstetric, and microbiologic parameters were prospectively evaluated. Premature rupture of membranes occurred less frequently (p less than 0.01) among women who received erythromycin (6%) versus placebo (16%). Preterm premature rupture of membranes also occurred less frequently, although not significantly (p = 0.3) in patients who received erythromycin (2%) versus placebo (5%). Erythromycin treatment significantly decreased the occurrence of premature rupture of membranes among women who were initially positive for Chlamydia trachomatis infection. Logistic regression analysis demonstrated that C. trachomatis (p = 0.05; odds ratio, 9), vaginal wash phospholipase C (p = 0.08; odds ratio, 6) and prior preterm birth (p = 0.007; odds ratio 17) were associated with increased risk of preterm birth. Bacterial vaginosis, Mycoplasma hominis, Ureaplasma urealyticum were not significantly associated with increased risk of preterm birth or preterm rupture of membranes. These findings support a role for selected lower genital tract microflora in preterm birth and premature rupture. Large controlled treatment trials of specific infections or conditions associated with preterm birth and premature rupture of membranes are required to confirm the value of antimicrobial treatments in prevention of microbial-associated preterm birth. The objective of this study was to assess whether antibiotic therapy plus tocolysis given to women in preterm labor would prolong pregnancy compared with tocolysis alone.
                A randomized, double-blind trial of intravenous mezlocillin and oral erythromycin therapy vs. placebo was used in addition to tocolysis among women in preterm labor < or =34 weeks gestation with intact membranes. Amniocentesis was performed, and chorioamnionic membranes were examined histologically and cultured for microorganisms after delivery.
                Clinical characteristics including gestational age at enrollment, frequency of contractions, cervical Bishop's score, and white blood cell count on admission were similar in the 2 groups. Antibiotic therapy was well tolerated. No significant differences in the interval to delivery, birth weight, and neonatal outcomes were observed between the 2 groups. Women in the antibiotic group had a significantly lower incidence of postpartum infections compared with women in the placebo group. Patients with evidence of upper genital tract infection in either group had a significantly shorter interval to delivery, lower gestational age at delivery, lower mean birth weight, and increased neonatal hospitalization time.
                Lack of an antibiotic effect on the gestational age at delivery may be due to the low prevalence of upper genital tract infection among unselected women in preterm labor, to advanced preterm labor unresponsive to antibiotic therapy, or to an inability of antibiotics given alone to inhibit the cytokine response. Further work is needed to identify markers of upper genital tract infection among women in preterm labor and to evaluate other potential therapeutic interventions. The aim of the study was to evaluate home uterine activity monitoring as an intervention in reducing the rate of preterm birth among women treated for preterm labor.
                A total of 186 women were treated in the hospital with magnesium sulfate for preterm labor and were prospectively randomly assigned to study groups; among these, 162 were ultimately eligible for comparison. Eighty-two of these women were assigned to the monitored group and 80 were assigned to an unmonitored control group. Other than monitoring, all women received identical prenatal follow-up, including daily perinatal telephone contact and oral terbutaline therapy. Outcome comparisons were primarily directed toward evaluation of preterm birth at <35 weeks' gestation. Readmissions for recurrent preterm labor and observations lasting <24 hours were evaluated in monitored and unmonitored groups. Compliance with monitoring was also evaluated in the monitored group.
                The monitored and control groups were demographically similar. According to a multivariate logistic regression model, women with cervical dilatation of >/=2 cm were 4 times more likely to be delivered at <35 weeks' gestation (P <.05). Gestational ages at delivery were similar in the monitored and control groups. There was no significant difference in the overall rate of preterm delivery at <35 weeks' gestation between the monitored group (10.9%) and the control group (15.0%). The overall rates of delivery at <37 weeks' gestation were high (48.8% and 60.0% for monitored and control groups, respectively), and the difference was not significant. The numbers of women with >/=1 instance of readmission and treatment for recurrent preterm labor were equal in the monitored and control groups. The numbers of women with >/=1 hospital observation lasting <24 hours were not different between the groups. Compliance with monitoring did not significantly differ for women who were delivered at <35 weeks' gestation, women with >/=2 cm cervical dilatation at enrollment, or for African American women.
                A reduction in the likelihood of preterm delivery at <35 weeks' gestation was not further enhanced by the addition of home uterine monitoring to the outpatient management regimens of women treated for preterm labor. To determine whether home uterine activity monitoring reduces the likelihood of preterm birth in women successfully treated for preterm labor in their current pregnancies.
                Women between 20-34 weeks' gestation who had been treated successfully for preterm labor were solicited to participate in a randomized clinical trial of home uterine activity monitoring versus routine high-risk care. The sample size of 56 was based on power calculations using the results of earlier investigators. Twenty-eight women were randomized to home uterine activity monitoring and 29 were assigned to the type of care appropriate for women discharged after hospitalization for parenteral treatment of preterm labor. One of the routine-care subjects was lost to follow-up. The two groups were comparable in distribution for race, insurance status, multiple gestation, marital status, gestational age at beginning of the study, and incidence of prior preterm birth.
                The 28 women receiving routine care had a 54% incidence of preterm birth, whereas the incidence was 57% in monitored women (relative risk 1.08, 95% confidence interval 0.6-1.9; P = .79). The incidences of delivery before 32 weeks and 34 weeks also were unaffected by the intervention.
                Home uterine activity monitoring is not effective in reducing the likelihood of preterm delivery in patients successfully treated for preterm labor in their current pregnancies. To test the effect of telephone calls from registered nurses to low-income pregnant women on the rates of low birth weight (LBW) and preterm births.
                A total of 1554 women receiving prenatal care in a public clinic who met study criteria and who consented were assigned randomly to intervention and control groups. Women in the intervention group received telephone calls from a registered nurse, one or two times weekly from 24 weeks' through 37 weeks' gestation. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated.
                Low birth weight rates were 10.9% in the intervention group and 14.0% in the control group (RR 0.75; 95% CI 0.55, 1.03; P = .072). For gestational age less than 37 weeks, rates were 9.7 in the intervention group and 11.0 in the control group (RR .87; 95% CI 0.62, 1.22; P = .415). In the subgroup of low-income black women 19 years of age and older, a statistically significant difference was found in preterm birth rates before 37 weeks (8.7% in the intervention group versus 15.4% in the controls [RR 0.56; 95% CI 0.38, 0.84; P = .004]).
                There was no difference in LBW or preterm births between intervention and control groups in the total sample. In a secondary analysis of black subjects 19 years of age and older, there was a significant difference in preterm birth rates. To screen for bacterial vaginosis (BV) and to investigate the effect of treatment with vaginal clindamycin in order to observe the effect on late miscarriage and delivery prior to 37 completed weeks (primary outcome).
                Randomised consent design for clinical trials according to Zelen.
                Southeast region of Sweden.
                A total of 9025 women were screened in early pregnancy.
                A total of 819 women with a Nugent score of 6 and above were considered to have BV and treated according to Zelen allocation. The incidence of late miscarriage and spontaneous (noniatrogenic) preterm birth was assessed.
                Late miscarriage and spontaneous preterm delivery before 37 weeks.
                Therapy with vaginal clindamycin had no significant impact on the incidence of spontaneous preterm delivery prior to 37 completed weeks; OR 0.90, 95% CI 0.40-2.02 (primary outcome variable). However, only 1 of 11 women in the treatment group versus 5 of 12 in the control group delivered prior to 33 completed weeks; OR 0.14, 95% CI 0.02-0.95. Treatment was associated with 32 days longer gestation for the 23 participants who had late miscarriage or spontaneous preterm birth (P= 0.024, Mann-Whitney U test) and significantly fewer infants had a birthweight below 2,500 g (secondary outcome). A follow up of infants born preterm 4 years postnatally indicated that extending gestational age did not increase the number of sequelae.
                Clindamycin vaginal cream therapy was associated with significantly prolonged gestation and reduced cost of neonatal care in women with BV. Early screening for BV and treatment with clindamycin saved approximately 27 euro per woman. We evaluated a comprehensive program of prenatal and postpartum nurse home visitation. The program was designed to prevent a wide range of health and developmental problems in children born to primiparous women who were either teenagers, unmarried, or of low socioeconomic status. During pregnancy, women who were visited by nurses, compared with women randomly assigned to comparison groups, became aware of more community services; attended childbirth classes more frequently; made more extensive use of the nutritional supplementation program for women, infants, and children; made greater dietary improvements; reported that their babies' fathers became more interested in their pregnancies; were accompanied to the hospital by a support person during labor more frequently; reported talking more frequently to family members, friends, and service providers about their pregnancies and personal problems; and had fewer kidney infections. Positive effects of the program on birth weight and length of gestation were present for the offspring of young adolescents (less than 17 years of age) and smokers. In contrast to their comparison-group counterparts, young adolescents who were visited by nurses gave birth to newborns who were an average of 395 g heavier, and women who smoked and were visited by nurses exhibited a 75% reduction in the incidence of preterm delivery. (P less than or equal to .05 for all findings.)
There is evidence that infection screening and treatment programs in pregnant women before 20 weeks gestation reduce preterm birth and preterm low birthweights. Future trials should evaluate the effects of types of infection screening program and the costs of introducing an infection screening program.