Acupuncture for Promotion of Timely Delivery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- timely delivery -- deliver on or before the EDC
研究概览
简要总结
The purpose of this study of 100 pregnant women is to determine if acupuncture using real needles that puncture the skin, starting at thirty seven weeks three days estimated gestational age (EGA), will increase the percentage of women delivering on or before the estimated date of confinement (EDC = 40 weeks EGA), compared with women treated identically but with placebo needles that do not puncture the skin.
详细描述
General Design This is a randomized controlled study of pregnant women to determine if acupuncture starting at thirty seven weeks three days EGA will increase the percentage of women delivering on or before the EDC, 40 weeks EGA.
The study participants will be recruited at three practices which utilize St. Francis Hospital in Wilmington Delaware, practices and hospital well known to the primary investigator. With the permission of the patients' physicians, charts of potentially eligible patients will be reviewed and eligible patients will be recruited into the study prior to 36 weeks EGA.
Upon enrollment, patients will be separated into nulliparous and parous groups and each group will be randomized into study intervention or control groups.
Of note, the candidate population is comprised of English and Spanish speakers. All invitational, explanatory, and consent materials and study instruments are available in both English and Spanish.
In addition to demographic information, initial and periodic "quality of life" and anxiety inventories will be administered. Based upon the current literature for applicability in this particular study population, the State-Trait Anxiety Index (STAI) and the Short Form 36 (SF-36) have been chosen as the test instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A singleton pregnancy in cephalic presentation
- •Between 34 and 37 weeks gestation
- •Their pregnancy dating (due date) confirmed by at least one first or second trimester ultrasound
- •No fetal or maternal contraindications to vaginal delivery
- •No contraindication to carry to EDC (40w 0d)
- •Have the capacity to understand the requirements of the study
排除标准
- •Without adequate information of dating
- •High risk of Cesarean Delivery
- •Currently receiving acupuncture outside of study
- •Uncertainty of gestational age dating (according to the chart documentation)
研究组 & 干预措施
Real Accupuncture
Acupuncture with a real needle that punctures the skin versus acupuncture needle that does not puncture the skin.
干预措施: Acupuncture (Procedure)
Non-puncturing Acupuncture
Acupuncture needle that touches but does not puncture the skin
干预措施: Non-puncturing Acupuncture Needle (Device)
结局指标
主要结局
timely delivery -- deliver on or before the EDC
次要结局
- State-Trait Anxiety Index, a self-administered questionnaire for assessment of anxiety
- Short Form 36, a self-administered questionnaire for assessment of quality of life status
- Modified Bishop's Score obtained to assess cervical ripening
- Maternal and newborn outcomes
研究者
John Farrar, MD
Associate Professor
University of Pennsylvania