Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery
研究概览
简要总结
Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma is increased three to four fold with operative delivery. This randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum Total Control® fitness and education program modified for pregnancy; and (2) a control group. Women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. Obstetrical data will also be collected.
详细描述
This will be a randomized controlled trial of primiparous women with singleton pregnancies who plan on delivering at Prentice Women's Hospital. Women will be recruited during their first trimester by their obstetrician as well as through standardized Northwestern Memorial Hospital flyers and ads. Demographic and delivery information will be obtained from the Northwestern Enterprise Data Warehouse (EDW), as well as by the attending midwife or physician at the time of delivery using a standardized Delivery Information Form. Women will also be asked about their other physical activities (including other forms of daily/weekly exercise) as well as whether or not they are participating in other birthing classes at the time of their first Total Control class (intervention group) or 2nd trimester visit with their providers (controls). All women will wear pedometers to track daily general activity.
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 (Investigator)
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
- •Singleton, primiparous pregnancy
- •Delivering at Prentice Women's Hospital
- •Able to participate based on PARmedX for pregnancy criteria
排除标准
- •Non-english or Spanish speaking
- •Age less than 18 years
- •Known condition requiring cesarean section
- •Currently enrolled in any kind of physical therapy
- •Unable to complete the program secondary to medical limitations
结局指标
主要结局
Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery
时间窗: At time of delivery (~6 months after baseline)
We will be comparing the proportion of women who undergo operative vaginal delivery versus natural spontaneous vaginal delivery among pregnant women participating in an antepartum fitness and education program and women not participating in the program. We will do so using standard Delivery Information Forms and Northwestern University's Electronic Data Warehouse (EDW).
Indication for operative vaginal delivery (if applicable)
时间窗: At time of delivery (~6 months after baseline)
We will compare the indication for operative vaginal delivery among women who undergo operative vaginal deliveries. We will do so using standard Delivery Information Forms and Northwestern University's Electronic Data Warehouse (EDW).
次要结局
- Level of worry/concern about the birthing experience (Penn State Worry Questionnaire)(Baseline, at time of delivery, 6 weeks postpartum)
- Pelvic Floor Symptoms (Pelvic Floor Distress Inventory)(Baseline, at time of delivery, 6 weeks postpartum)
- Obstetrical Complications (using data from Northwestern's Electronic Data Warehouse)(From time of delivery to 6 weeks Postpartum)
- Knowledge about the birthing experience ( Birth Technology and Maternal Roles in Birth: Knowledge and Attitudes of Canadian Women Approaching Childbirth for the First Time Questionnaire)(Baseline, at time of delivery, 6 weeks postpartum)
- Sexual Function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)(Baseline, at time of delivery, 6 weeks postpartum)
- Satisfaction with birthing experience (Satisfaction with Childbirth Rating Scale (SatCh) and Mackey Satisfaction with Childbirth Rating Scale)(At time of delivery and during 6 weeks postpartum)
- Postpartum Depression Incidence and Risk Factors ( Edinburgh Postnatal Depression Scale)(6 weeks postpartum)
研究者
Christina Lewicky-Gaupp
Assistant Professor of Obstetrics and Gynecology, Associate Residency Program Director, Medical Director of PEAPOD clinic
Northwestern University