跳至主要内容
临床试验/NCT02550730
NCT02550730已完成不适用

Birth Sisters Best Beginnings Evaluation

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
411
试验地点
2
主要终点
Rates of cesarean sections

研究概览

简要总结

Peer support during labor, birth and the perinatal period (also known as "doula" support) has been shown in some studies to reduce cesarean rates, postpartum depression and increase breastfeeding rates. The purpose of this program evaluation is to prospectively assess the clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the few established, hospital-based programs in the United States. To enhance the capability of the Birth Sisters Program to impact social determinants of perinatal health in a low-income population, the program evaluation will include the addition of Medical Legal Partnership for Children's (MLP) training and referral services. This program will be described as the Birth Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB compared with no Birth Sister support for women receiving maternity care at Boston Medical Center. Eligible women will be randomly assigned either BBB services or usual care. All women will be consented and interviewed in the mid-second trimester of pregnancy and interviewed again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy, continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the home or at Boston Medical Center. The usual care group will receive no birth sister support but does have access to standard interdisciplinary maternity care services. The primary outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including depression, social functioning and self-efficacy.

详细描述

Racial and income disparities in maternal and perinatal outcomes in the United States are large and persistent. Maternal and infant morbidity and mortality alike are 2-3 times higher in the black population than in the white population. Poor women in general are more likely to have babies born prematurely or with low birth weight compared with women from a higher socio economic strata. Infants born either too early or too small are at risk for a lifetime of disabilities, perpetuating the cycle of poverty and poor health. Low-income and minority populations are also less likely to breastfeed, putting children and mothers at higher risk for a variety of health problems, including obesity, diabetes, and some cancers.

In addition to income and racial disparities, the nation as a whole struggles with inferior maternity care outcomes when compared with other developed countries. This is true despite considerably higher rates of maternity care expenditures. The unnecessarily high rate of cesarean birth is one factor that contributes to both high cost and poor outcomes. The Society of Maternal and Fetal Medicine and the American Congress of Obstetricians and Gynecologists have both called for innovations and strategies to reduce the high rate of cesarean birth.

Community "doulas", or peer support during pregnancy, labor and birth, is one intervention that may both improve outcomes for low-income populations and lower the cost of maternity care. A culturally competent peer who provides caring support during a crucial life transition may lower stress and improve engagement in healthcare, therefore improving health status during pregnancy and lowering the need for costly medical care. Low income and minority women are more likely to desire a doula during labor and less likely to have access to their services.

The Birth Sisters Program One of the few hospital-based community doula programs in the country, Boston Medical Center's Birth Sisters Program has provided multicultural doula support to childbearing women since 1999. The approximately 20 per diem Birth Sisters together speak over 10 languages. Birth Sisters are recruited from the communities served by the BMC maternity service and provide peer support throughout the perinatal period. Prenatal home visits focus on creating a relationship, identifying psychosocial needs and providing childbirth and breastfeeding education. The Birth Sister also assesses whether the woman is lacking in essential resources such as housing, food and baby care items. She then refers her client to social service agencies and helps her navigate those services as needed. During labor, the Birth Sister offers physical and emotional comfort measures, advocacy for the mother, and help with the first breastfeeding. Postpartum home visits provide assistance in the transition to motherhood, help around the house so that the mother can rest, education on breastfeeding, parenting and infant care, and connections to needed medical and social services.

The Birth Sisters Program does not have resources to serve all women who would like a Birth Sister. investigators are currently able to meet approximately 20 percent of the demand. Prenatal providers have traditionally been the primary referral source for the program, with some providers referring often and others rarely referring. This has created inequities in whether women have a chance to receive a Birth Sister. investigators are now changing the referral process to systematically screen all potentially eligible women and allow eligible women to self-refer to the Birth Sister pool. A limited number of Birth Sister assignments are made from this pool each month. Women are informed about the Birth Sister pool through flyers placed in the obstetrical ultrasound unit and, if they would like to be in the pool, they fill out a form with their contact information and place it in the "Birth Sister pool" box. Due to the budget limitations, investigators restrict referrals to women who benefit most, including first time mothers with public insurance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Birth Sisters

Experimental

Half of the women who agree to participate in the evaluation will be randomized to the Birth Sisters Best beginnings for Babies Program, which includes community doula support and consultation with Medical Legal Partnership when indicated.

干预措施: Birth Sisters Best Beginnings for Babies (Behavioral)

Routine care

Active Comparator

Half of the women who agree to participate in the evaluation will be randomized to the usual maternity care group

干预措施: Usual maternity care (Other)

结局指标

主要结局

Rates of cesarean sections

时间窗: at delivery

total cesareans/total births as assessed by medical record abstraction

次要结局

  • Rates of preterm birth(at delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Mottl-Santiago

Midwife and Assistant Professor

Boston Medical Center

研究点 (2)

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