A randomized trial of nurse intervention to reduce preterm and low birth weight births. Randomized trial of comprehensive prenatal care for low-income women: effect on infant birth weight. A randomized trial of nurse specialist home care for women with high-risk pregnancies: outcomes and costs. Randomized controlled trial of antenatal social support to prevent preterm birth. Psychosocial support for maternal stress during pregnancy: effect on birth weight. A randomized trial of augmented prenatal care for multiple-risk, Medicaid-eligible African American women. Evaluation of the home-visiting system for women with threatened preterm labor: results of a randomized controlled trial. Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. Domiciliary midwifery support in high-risk pregnancy incorporating telephonic fetal heart rate monitoring: a health technology randomized assessment. A randomized trial of psychosocial support during high-risk pregnancies. The Latin American Network for Perinatal and Reproductive Research. [Domiciliary care of pathological pregnancies by midwives. Comparative controlled study on 996 women (author's transl)]. A randomized trial of an empirically-derived social support intervention to prevent low birthweight among African American women. A randomized study of a domiciliary antenatal care scheme: the effect on hospital admissions. A randomized trial of nurse-midwifery prenatal care to reduce low birth weight. A randomized controlled trial of the provision of a social support service during pregnancy: the South Manchester Family Worker Project.
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. The effect of comprehensive prenatal care on birth weight was examined using a prospective randomized design. A total of 428 pregnant women were randomly assigned to comprehensive prenatal care (n = 217) or standard prenatal care (n = 211). Comprehensive care was provided by a multidisciplinary team of nurse-midwives, social workers, a nutritionist, paraprofessional home visitors, and a psychologist. Standard prenatal care consisted of medical care provided by obstetric residents. Multiple regression analysis using behavioral, demographic, and medical variables showed a strong relationship between the set of predictors and birth weight. Comprehensive care was related to higher birth weights for primiparous but not multiparous mothers. Separate analyses of variance for primiparas and multiparas similarly showed a favorable effect of comprehensive care on birth weight for primiparous but not multiparous mothers. To examine prenatal, maternal, and infant outcomes and costs through 1 year after delivery using a model of prenatal care for women at high risk of delivering low-birth-weight infants in which half of the prenatal care was provided in women's homes by nurse specialists with master's degrees.
                Randomized clinical trial.
                A sample of 173 women (and 194 infants) with high-risk pregnancies (gestational or pregestational diabetes mellitus, chronic hypertension, preterm labor, or high risk of preterm labor) were randomly assigned to the intervention group (85 women and 94 infants) or the control group (88 women and 100 infants). Control women received usual prenatal care. Intervention women received half of their prenatal care in their homes, with teaching, counseling, telephone outreach, daily telephone availability, and a postpartum home visit by nurse specialists with physician backup.
                For the full sample, mean maternal age was 27 years; 85.5% of women were single mothers, 36.4% had less than a high school education, 93.6% were African American, and 93.6% had public health insurance, with no differences between groups on these variables. The intervention group had lower fetal/infant mortality vs the control group (2 vs 9), 11 fewer preterm infants, more twin pregnancies carried to term (77.7% vs 33.3%), fewer prenatal hospitalizations (41 vs 49), fewer infant rehospitalizations (18 vs 24), and a savings of more than 750 total hospital days and $2,496,145 [corrected].
                This model of care provides a reasoned solution to improving pregnancy and infant outcomes while reducing healthcare costs. To test the effect of a programme of additional antenatal social support on the occurrence of preterm birth (a birth from 20 to 36 weeks gestation) in women at risk of preterm birth.
                A prospective randomized controlled trial. The design was one of randomization before consent for a new treatment.
                Three public hospital antenatal clinics in Perth and the offices of 87 obstetricians and general practitioners in Western Australia.
                1970 pregnant women with poor obstetric histories entered the trial; 983 of these were randomly allocated to the programme group and 987 to the control group.
                Normal antenatal care was provided for both groups. In addition, members of the programme group were offered an intervention aimed at providing expressive (emotional) social support, consisting of antenatal home visits and telephone calls by midwives. Of the women allocated to the programme group, 24 refused consent and 69 were not traced before completion of their pregnancies, the remaining 890 women (90.5%) agreed to enter the programme, and each received at least one intervention.
                Gestational age at completion of the pregnancy. A pregnancy ending before 20 weeks was labelled a miscarriage.
                There were 126/981 (12.8%) preterm births in the programme group and 147/986 (14.9%) in the control group. The outcome data for two women in the programme group and one in the control group could not be found. The unadjusted odds ratio for preterm birth in the programme was 0.84 (95% CI 0.65-1.09). The observed relative reduction in preterm births associated with the programme was 13.8% (95% CI -8.2% to +31.5%) and the trial had a 60% power to exclude a true relative reduction of 25%.
                The results of this trial and those of other controlled clinical trials provide little evidence for the effectiveness of social support interventions in the prevention of preterm birth in women with poor obstetric histories. In a previous study we showed that moderate to severe stress during pregnancy was inversely related to infant birth weight. Using the same criteria for stress (according to the Social Readjustment Rating Scale of Holmes and Rahe), we studied 86 white mothers with singleton pregnancies and with no known medical or obstetric risk factors for reduced birth weight. After strict randomization, data were analyzed for 43 mothers who received psychosocial support between enrollment at +/- 20 weeks and delivery at +/- 38 weeks and for 43 control mothers who received standard care at the antenatal clinic. In the supported group seven infants weighed less than 3000 gm at birth versus 18 control infants (p = 0.008), and analysis revealed that this effect was more the result of improved intrauterine growth than of prolongation of pregnancy. These findings are of little clinical relevance as far as the neonate is concerned, but they do indicate that psychosocial support has a significant effect on birth weight. It is possible that previous studies that have looked only for an effect on low- or very-low-birth-weight rates might have missed this clinically measurable benefit of counseling. This project investigated whether augmented prenatal care for high-risk African American women would improve pregnancy outcomes and patients' knowledge of risks, satisfaction with care, and behavior.
                The women enrolled were African American, were eligible for Medicaid, had scored 10 or higher on a risk assessment scale, were 16 years or older, and had no major medical complications. They were randomly assigned to augmented care (n = 318) or usual care (n = 301). Augmented care included educationally oriented peer groups, additional appointments, extended time with clinicians, and other supports.
                Women in augmented care rated their care as more helpful, knew more about their risk conditions, and spent more time with their nurse-providers than did women in usual care. More smokers in augmented care quit smoking. Pregnancy outcomes did not differ significantly between the groups; however, among patients in augmented care, rates of preterm births were lower and cesarean deliveries and stays in neonatal intensive care units occurred in smaller proportions. Both groups had lower-than-predicted rates of low birthweight.
                High-quality prenatal care, emphasizing education, health promotion, and social support, significantly increased women's satisfaction, knowledge of risk conditions, and perceived mastery in their lives, but it did not reduce low birthweight. We assessed the effectiveness of the home-visiting system in reducing the care provided in maternity units, especially hospitalization, and attempted to establish whether this system increases women's satisfaction with medical care. The trial involved 158 women and was conducted in four maternity units in Paris. A policy of one or two weekly visits by domiciliary midwives was compared with the usual policy of the hospitals. The study was restricted to women with moderate threatened preterm labor between 26 and 36 weeks of gestation. No decrease in the number of women hospitalized or the number of days spent in hospital was observed in the intervention group, but the number of prenatal visits to outpatient clinics was significantly smaller in the intervention than control group. Satisfaction with medical care during the episode of threatened preterm labor was much greater in the intervention group. Home visits by a midwife were considered by the women to be a better care system than numerous outpatient visits or hospitalization. Our results for medical care suggest that the introduction of the home-visiting system did not greatly alter medical practice in the maternity units, although this system had been designed to avoid or reduce hospitalization. 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.) We conducted a health technology assessment of the care of women with high-risk pregnancies in the South Wales valleys. Women in the control arm were intended to receive conventional care with standard midwifery visits. Women in the intervention arm received additional or longer visits and domiciliary fetal heart rate telemonitoring. Eighty-one mothers were randomized. There were significant differences in midwifery intervention resources between domiciliary and control groups, with the former receiving a mean of 3.7 visits lasting 33.5 min, compared with 1.4 visits lasting 12.8 min for the latter. There were slightly more spontaneous labours and fewer Caesarean sections in the domiciliary group. Maternal satisfaction and anxiety were high in both groups. Domiciliary care increased the service costs by 21.02 Pounds per woman in terms of extra midwife travel and visiting time, and by a further 18.38 Pounds per woman in home monitoring equipment costs. This, however, was more than offset by health service savings from fewer clinic visits (35.60 Pounds) and fewer clinic ultrasound scans (9.01 Pounds). Adding the reductions in lost productivity to women and their partners (34.51 Pounds) suggests that domiciliary care was cheaper than conventional care, even if it did not greatly reduce inpatient days (a reduction nonetheless saving 184.24 Pounds). While clinical processes were similar in both groups, there were useful practical advantages and savings for patients and the health service from the domiciliary intervention. It is often suggested that psychological and social support and health education for women at high risk for delivering a low-birth-weight infant can improve the outcomes of pregnancy, but the evidence is inconclusive. We undertook this prospective trial to evaluate a program of home visits designed to provide psychosocial support during pregnancy.
                At four centers in Latin America, 2235 women at higher-than-average risk for delivering a low-birth-weight infant were recruited before the 20th week of pregnancy. The women were randomly assigned either to an intervention group (n = 1115) that received four to six home visits from a nurse or social worker in addition to routine prenatal care or to a control group (n = 1120) that received only routine prenatal care (with a mean of eight prenatal visits). The principal measures of outcome were low birth weight (< 2500 g), preterm delivery (< 37 weeks of gestation), and specified categories of maternal and neonatal morbidity.
                The women who received the home visits as well as routine prenatal care had outcomes that differed little from those of the women who received only routine care. The risks of low birth weight (odds ratio for the intervention group as compared with the control group, 0.93; 95 percent confidence interval, 0.68 to 1.28), preterm delivery (odds ratio, 0.88; 95 percent confidence interval, 0.67 to 1.16), and intrauterine growth retardation (odds ratio, 1.08; 95 percent confidence interval, 0.83 to 1.40) were similar in the two groups. There was no evidence that the intervention had any significant effect on the type of delivery, the length of hospital stay, perinatal mortality, or neonatal morbidity in the first 40 days. There was no protective effect of the psychosocial-support program even among the mothers at highest risk.
                Interventions designed to provide psychosocial support and health education during high-risk pregnancies are unlikely to improve maternal health or to reduce the incidence of low birth weight among infants. In order to evaluate the effectiveness of domiciliary care of pathological pregnancies by midwives a comparative study was carried out on two groups of pregnant women, the one group being treated by this new method of caring fort them, the other by traditional care. There was random selection for the two groups. The results of this comparative controlled study show that when midwives care for these patients at home once a pathological condition has become established premature labour and admission to hospital is not avoided. A more preventive attitude developed. This implies that they intervene very early in pregnancy as soon as risk factors for pathological conditions appear without waiting for the pathological conditions themselves to develop. Previous clinical trials of social support interventions to reduce low birthweight (LBW) have not fully capitalized on findings from social science research, and therefore have not used empirically-derived criteria to define a low social support population or to develop the intervention. To overcome limitations of previous studies, this randomized clinical trial tested the hypothesis that an empirically-derived social support intervention would reduce LBW among African American women. Based on prior work, African American women were identified as at-risk for LBW due to inadequate social support if they lacked support from their mothers or male partners. Focus groups were used in this study to develop a culturally-relevant intervention. Adult low-income African American pregnant women (n = 319) were tested for inadequate social support in mid-pregnancy. Of these, 114 (36%) low-support women were identified and randomly assigned to the intervention group (n = 56) or control group (n = 58). The intervention was designed to provide the support usually provided by the pregnant woman's mother or male partner. It consisted of four standardized face-to-face sessions at two week intervals and telephone contact in the intervening weeks. Birthweight was obtained blinded from charts or birth certificates, with 99% follow-up. The rate of LBW (below 2500 grams) was 9.1% in the intervention group compared to 22.4% in the control group (P < 0.05). Contrary to previous studies, this social support intervention was effective in reducing the rate of LBW. It is promising that this intervention was successful for African Americans because the rate of LBW is twice as high among African Americans than among Caucasians. A preliminary randomized study has been made of a domiciliary management scheme which incorporates telephonic fetal heart rate monitoring for women with high-risk pregnancies. In this paper we report effects of the scheme on the pattern of hospital admissions. Sixty women were randomized 2:1 for domiciliary surveillance or for conventional hospital care, with 40 and 17 records finally available for analysis. The groups were well matched for maternal, obstetric and socio-economic characteristics. In the domiciliary group, 21 (53%) of the women avoided hospital admission altogether, the admission rate was more than halved, and the mean proportion of the time spent in hospital was reduced from 50% to 16% of the observation period. The women who received domiciliary care were generally satisfied with the scheme. Our study confirms expectations that carefully planned domiciliary surveillance can reduce the number and duration of hospital admissions. In a randomized, controlled trial in five regional centers with state health department clinics, 1458 women at high risk for low birth weight (LBW) outcome received either prenatal interventions provided by nurse-midwives and nurses under their supervision or the standard high-risk prenatal care provided by obstetricians. The intervention administered by the nurse-midwives included patient education to identify the signs and symptoms of preterm labor, activity counseling in response to monitoring of the cervix by frequent examinations, stress reduction by enhancing social support, nutrition counseling with emphasis on weight gain, and substance-abuse counseling. For women in the control group, care was provided by obstetricians according to local standards for the management of high-risk pregnancies. We hypothesized that the LBW rate among live births to women who had received care from nurse-midwives would be lower than that in the control group. Although the LBW rate was lower in the intervention group than in the control group, the observed difference was not statistically significant. Race was not prespecified as a possible effect modifier, but examination of the data post hoc suggested that black women at high statistical risk of giving birth to an LBW infant may have derived benefit from the program. Although the results do not suggest any striking advantage of the nurse-midwifery intervention over standard obstetric care for women at high statistical risk of having an LBW infant, neither do they suggest any disadvantage. Nurse-midwives could provide care to certain populations of high-risk women and facilitate future coverage of these presently underserved populations. A pilot scheme was introduced in Manchester to provide additional social support to pregnant women at above average risk of giving birth to a low-birthweight baby. The help of lay workers, known as family workers, was made available to eligible women. The effect on infant birthweight of offering the help of a family worker was assessed by a randomized controlled trial. No significant differences were observed between the experimental and control group, but on a number of grounds the interpretation of this finding is not straightforward, and further research is recommended.
Pregnant women need the support of caring family members, friends, and health professionals. While programs which offer additional support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or preterm baby, they may be helpful in reducing the likelihood of antenatal hospital admission and caesarean birth.