Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. A randomized trial of psychosocial support during high-risk pregnancies. The Latin American Network for Perinatal and Reproductive Research. A randomized trial of nurse-midwifery prenatal care to reduce low birth weight. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Randomized controlled trial of antenatal social support to prevent preterm birth. Psychosocial support for maternal stress during pregnancy: effect on birth weight. Randomized trial of comprehensive prenatal care for low-income women: effect on infant birth weight. Improved birth outcomes associated with enhanced Medicaid prenatal care in drug-using women infected with the human immunodeficiency virus. Does supplementary prenatal nursing and home visitation support improve resource use in a universal health care system? A randomized controlled trial in Canada. Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions. Aiming to increase birth weight: a randomised trial of pre-pregnancy information, advice and counselling in inner-urban Melbourne. Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. A clinical trial to reduce the rate of low birth weight in an inner-city black population. Effects of labor support from close female relative on labor and maternal satisfaction in a Thai setting. Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery.
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.) 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 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. To estimate whether an organized, consistent program of dietary and lifestyle counseling prevents excessive weight gain in pregnancy.
                This randomized controlled trial assigned women to receive either an organized, consistent program of intensive dietary and lifestyle counseling or routine prenatal care. The primary study outcome was the proportion of patients whose gestational weight gain was within the Institute of Medicine (IOM) guidelines. Secondary outcomes included mode of delivery, rate of operative vaginal delivery, neonatal weight, and the incidence of preeclampsia, gestational diabetes mellitus (GDM), vaginal/perineal lacerations, and shoulder dystocia.
                A total of 100 women were randomized to the study (lifestyle counseling 57, routine prenatal care 43). Baseline demographic characteristics were similar between the study groups. The lifestyle counseling group gained significantly less weight than did the routine prenatal care group (28.7+/-12.5 lb compared with 35.6+/-15.5 lb, P=.01). The routine prenatal care group had significantly more cesarean deliveries due to "failure to progress" (routine prenatal care 58.3% compared with lifestyle counseling 25.0%, P=.02). Across groups, patients who were not adherent to the IOM guidelines had significantly heavier neonates (adherent 3,203.2+/-427.2 g compared with not adherent 3,517.4+/-572.4 g, P<.01). Nulliparous women gained significantly more weight than did parous women (36.5+/-14.5 lb compared with 27.7+/-12.7 lb, P<.01). The most predictive factor of IOM adherence was having a normal prepregnancy body mass index. No statistically significant differences were noted between the groups in adherence to IOM guidelines, rate of cesarean delivery, preeclampsia, GDM, operative vaginal delivery, or vaginal lacerations.
                An organized, consistent program of dietary and lifestyle counseling did reduce weight gain in pregnancy.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00792480
                I. 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. 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 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. The addition of supplementary prenatal support may improve the health and well-being of high-risk women and families. The objective of this randomized controlled trial was to examine the impact of supplementary prenatal care on resource use among a community-based population of pregnant women.
                Pregnant women from three urban maternity clinics were randomized (a) to current standard of physician care, (b) to current standard of care plus consultation with a nurse, or (c) to (b) plus consultation with a home visitor. Participants were 1,352 women who received 3 telephone interviews. The primary outcome was resource use (e.g., attended prenatal classes, used nutritional counseling).
                Overall, those in the nurse intervention group were more likely to attend an "Early Bird" prenatal class and parenting classes, and to use nutrition counseling and agencies that assist with child care. Women provided with extra nursing and home visitation supports were more likely to use a written resource guide, nutrition counseling, and agencies that assist with child care. Among women at higher risk (e.g., language barriers, young maternal age, low income), the nurse intervention significantly increased use of early prenatal classes, whereas the nurse and home visitor intervention significantly increased use of the written resource guide and nutrition counseling. The intervention substantially increased the amount of information received on numerous pregnancy-related topics but had little impact on resource use for mental health and poverty-related needs. Among those with added support, resource use among low-risk women was generally greater than among high-risk women.
                Additional support provided by nurses, or nurses and home visitors, can successfully address informational needs and increase the likelihood that women will use existing community-based resources. This finding was true even for high-risk women, although this intervention did not reduce the difference in resource use between high- and low-risk women. Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
                Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
                Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
                The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions. In the 1980s there was substantial interest in early pregnancy and pre-pregnancy interventions to increase birth weight and reduce preterm birth. We developed an inter-pregnancy intervention, implemented in a randomised controlled trial, to be provided by midwives at home soon after women's first birth.
                MCH nurses invited women to take part during their home visit to new mothers. Women's contact details, with their permission, were passed to the study midwife. She had a randomisation schedule to which women's names were added before she met the women or their partners. All women recruited had a home visit from the study midwife with a discussion of their first pregnancy, labour and birth and the postpartum experience. Women in the intervention arm received in addition a pre-pregnancy intervention with discussion of social, health or lifestyle problems, preparation and timing for pregnancy, family history, rubella immunisation, referrals for health problems, and a reminder card. The primary outcome was defined as a birth weight difference in the second birth of 100 g (one-sided) in favour of the intervention. Additional data collected were gestational age, perinatal deaths and birth defects. Analyses used EPI-INFO and STATA.
                Intervention and comparison groups were comparable on socioeconomic factors, prior reproductive history and first birth outcomes. Infant birth weight in the second birth was lower (-97.4 g,)) among infants in the intervention arm. There were no significant differences between intervention and comparison arms in the proportion of women having a preterm birth, an infant with low birthweight, or an infant with a birth weight <10th percentile. There were more adverse outcomes in the intervention arm: ten births <32 weeks), compared with one in standard care, and more infants with a birth weight <2000 g, 16 compared with two in standard care
                As the primary outcome was envisaged to be either improved birth weight or no effect, the study was not designed to identify the alternative outcome with confidence. Despite widespread support for pre-pregnancy interventions to improve maternal and perinatal health, this first randomised controlled trial of a multi-component intervention provided at home, did not have a beneficial outcome. Although obesity in pregnancy continues to be associated with ongoing health problems, many clinicians have been reluctant to place nondiabetic, obese, pregnant women on a monitored, calorie-appropriate nutritional regimen for fear of fetal growth restriction, low birth weight, or starvation ketosis.
                A total of 257 patients were enrolled in the randomized study, with a loss-to-follow-up rate of 9.73%. Patients were assigned randomly to either the control (unmonitored) group (n=116), consisting of conventional prenatal dietary management, or to the study (monitored) group (n=116), which was prescribed a balanced nutritional regimen and were asked to record in a diary all of the foods eaten during each day. Women were eligible for the study if they were pregnant with a single fetus between 12 and 28 weeks of gestation and had a prepregnancy body mass index of more than 30 kg/m2. The primary outcome was to compare perinatal outcomes in the control vs the study groups. The secondary measure was to compare outcomes in adherent and nonadherent patients in the study group.
                Omnibus MANOVA showed statistically significant differences between the study and control groups regarding 3 variables: (1) gestational hypertension, p < .46; (2) mother's last weight before delivery, p < .001; and (3) mother's 6-week postpartum weight, p < .001. Patients gaining 15 pounds or more during their pregnancy showed statistically significant differences between the groups for 8 variables.
                Obese pregnant women may be placed on a healthy, well-balanced, monitored nutritional program during their antepartum course without adverse perinatal outcomes. The goal of our study was to measure the effectiveness of a home-based intervention for prevention of low birth weight with 154 high-risk, low-income black women attending a prenatal clinic in Cleveland.
                Based on previous research, risk was defined by clinic registration between the 17th and 28th weeks of gestation, low family functioning score, and experience of at least one stressful life event prior to registration. Optional factors included being a smoker, a low maternal weight-height ratio, being age 27 or older, and a previous premature birth. A 21-item family function screen previously validated in a similar population was the primary determinant of psychosocial risk. Low birth weight was defined as weight less than 2,500 g regardless of gestational age.
                There was no decrease in the rate of low birth weight for women who received four home visits focusing on smoking, drug and nutrition education, support, and links with community services, compared to women who received no visits. The number of prenatal visits was significantly higher in the intervention group, but an increased number of prenatal visits did not correlate with a reduced rate of low birth weight. Despite previous research, the family function screen was not an effective predictor of low birth weight in our study. A revised equation involving a history of previous premature birth, smoking, and a low maternal weight-height ratio did predict low birth weight.
                These findings question the utility of short-term psychosocial interventions for influencing low birth-weight rates in low-income black clinic populations. The family function screen was not cross validated. Integration of any psychosocial intervention with the routine prenatal care occurring in the obstetrical clinic is suggested for future research. To evaluate the efficacy of a close female relative providing emotional and physical support during active labor and birth.
                Randomized, two-group controlled clinical trial.
                Regional teaching hospital in the eastern part of Thailand with 782 beds.
                Primiparous women (N = 120) whose gestational ages were ≥ 36 weeks and who had uncomplicated pregnancies.
                Participants were randomly assigned to receive usual care and support from a chosen close female relative from admission until 2 hours after birth or usual care only. Within 24 hours of birth, labor outcomes (length of labor & type of birth) and levels of maternal satisfaction were assessed.
                Those in the experimental group had a significantly shorter duration of active labor and were more satisfied with their childbirth experiences than those in the control group. Differences between groups with respect to incidence of spontaneous delivery were not found.
                A close female relative was effective in providing supportive care during labor and delivery. The integration of this nursing intervention for women and their families at public hospitals in Thailand is supported.
                © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. 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.
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.