Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Newborn APGAR Score
研究概览
简要总结
A randomized clinical trial (RCT) to evaluate the impact of unrestricted low fat, low residue oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.
详细描述
This study is a quantitative, randomized experimental design study to determine the impact of unrestricted low fat, low residue oral intake during labor on the indicated outcome variables and patient satisfaction. The comparison group will continue standard care of being allowed a clear liquid during active labor (≥6cm dilation), while the experimental group would be allowed to self-regulate oral intake with a low fat, low residue diet during active labor.
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)
盲法说明
Personal identification removed (use of personal identification code)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age and older
- •37 weeks gestation or greater at time of admission
- •singleton fetus
- •cephalic presentation
- •who plan to labor/deliver at DGMC (military beneficiaries).
排除标准
- •Morbid/severe obesity (pre-pregnancy BMI ≥40 kg/m2
- •hypertension (to include pre-eclampsia or eclampsia)
- •previous cesarean section
- •uncontrolled gastroesophageal reflux disease (GERD) (symptomatic with medication)
- •past history or current diagnosis of hyperemesis gravidarum
- •food allergies to any items contained in the gastric/soft bland diet
- •patients utilizing nitrous oxide for labor analgesia (should this treatment be available at DGMC)
- •Difficult airway as defined by the anesthesia staff.
- •Mallampati score 3 or 4
- •Thyroid mental distance less than 7 cm or 3 finger breaths
- •Mouth opening less than 3 finger breaths
- •Short thick neck, Micrognathia
- •Further indications as determined by the anesthesia provider doing the anesthesia preoperative assessment (pregnancy in and of itself will not be considered a disqualification due to airway changes during labor)" in order to define difficult airway per anesthesia.
- •Under age 18
- •Additional clinical risk factors as determined by the care provider
结局指标
主要结局
Newborn APGAR Score
时间窗: 5 min of life
\< 7
Mode of delivery
时间窗: at birth
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Aspiration
时间窗: active labor (6cm or greater dilation) through delivery of the infant
# episodes
Duration of labor
时间窗: active labor (6cm or greater dilation) through delivery of the infant
#hours/minutes
Maternal Satisfaction
时间窗: active labor (6cm or greater dilation) through delivery of the infant
open ended survey question
Nausea
时间窗: active labor (6cm or greater dilation) through delivery of the infant
# episodes
Vomiting
时间窗: active labor (6cm or greater dilation) through delivery of the infant
# episodes
次要结局
未报告次要终点
研究者
Jeanette Anderson
Branch Chief, Provision of Inpatient Nursing Care
David Grant U.S. Air Force Medical Center