Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 6
- 主要终点
- Incidence of maternal anemia
研究概览
简要总结
This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.
详细描述
There are more than 3.5 million births per year in the United States. A substantial portion of these births (approximately 25-30%) occur in the context of significant adverse pregnancy outcomes (APOs) including preterm birth (PTB), hypertensive disorders of pregnancy (HDP), small-for-gestational-age birth (SGA), and intrauterine fetal demise (IUFD). Moreover, these complications significantly increase the risk of both maternal and perinatal morbidity and mortality and are associated with adverse health consequences throughout the life course of both individuals. Anemia in pregnancy has been consistently cited as an important factor in and upstream of APOs such as PTB and HDP, severe maternal morbidity, and maternal mortality, and for disparities in these outcomes as well.
This study will expand our understanding of addressing SDoH, including linkage to services that mitigate SDoH. This information can inform future interventions that address SDoH. Creating new tools to address the needs and strengths of obstetric patients, and encouraging their use, will improve the management of patient care during and after pregnancy.
The patient sample will include obstetric patients receiving care at the OSUWMC McCampbell OB/GYN clinic or the OSUWMC Outpatient Care East OB/GYN clinic. A total of 550 patients will participate in the study and be randomly assigned to either the intervention or control group. We will collect maternal and child health outcome data using patient electronic health records and surveys.
At the time of randomization at the patient's prenatal appointment, a researcher will use a survey to collect participant baseline data, including patient demographics and patient-reported outcomes. This information will be collected again during a study visit during the patient's prenatal appointment when the patient is 28-32 weeks gestation.
Final data collection from patient records will occur after delivery (for both intervention and control groups). Research staff will extract information from patients' and their baby's medical records, including maternal and perinatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Less than 20 weeks and 6 days pregnant upon enrollment
- •At least 18 years of age
- •Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East
- •Singleton pregnancy and fetus with a heartbeat
- •English speaking
- •Able to receive text messages
排除标准
- •Has a significant medical condition (eg sickle cell disease) that is a cause of anemia
- •Has a plan for transfusion during pregnancy
研究组 & 干预措施
Standard of care
No motivational interviewing or text messages will be provided.
干预措施: Standard of care (Behavioral)
BETTER Intervention
Patients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs.
干预措施: BETTER: motivational interviewing and text messaging (Behavioral)
结局指标
主要结局
Incidence of maternal anemia
时间窗: At delivery
Hemoglobin \< 11.0 g/dL
次要结局
- Incidence of Small for gestational age birth(At birth)
- Incidence of Large for gestational age(At birth)
- Incidence of Cesarean Delivery(At delivery)
- Incidence of Prenatal care visits(From randomization through delivery)
- Length of stay (days)(Immediately after discharge from the delivery hospitalization)
- Incidence of Pre-term birth(At delivery)
- Incidence of Hypertensive disorders of pregnancy(Through study completion, approximately 6 months)
- Incidence of infection(Through study completion, approximately 6 months)
- Incidence of Postpartum hemorrhage(Through study completion, approximately 6 months)
- Incidence Severe maternal morbidity(Through study completion, approximately 6 months)
- Incidence of maternal mortality(Through study completion, approximately 6 months)
- Incidence of NICU admission(Through study completion, approximately 6 months)
- Incidence of Antepartum admission(From randomization through delivery)
- Postpartum re-admission(From delivery discharge through 6 weeks post partum)
- Incidence of Perinatal mortality(Through study completion, approximately 6 months)
研究者
Ann McAlearney
Professor of Family Medicine and Executive Director, CATALYST
Ohio State University