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临床试验/NCT02080429
NCT02080429Unknown不适用

Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2014年3月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
540
试验地点
2
主要终点
Rate of spontaneous vaginal delivery

研究概览

简要总结

Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes. Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population. Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women. the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia. This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage. Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.

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
Single (Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
  • Regional anesthesia
  • Nulliparous (defined as no deliveries after 20 weeks gestation)
  • Gestational age of 37 0/7 weeks and greater
  • Singleton Pregnancy

排除标准

  • Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
  • No regional anesthesia
  • Multiparous
  • Gestational age of less than 37 0/7 weeks
  • Multiple gestations
  • Maternal fever prior to second stage
  • Severe fetal anomalies (incompatible with life)

结局指标

主要结局

Rate of spontaneous vaginal delivery

时间窗: At delivery

次要结局

  • Rate of infections (defined as fever and / or antibiotic initiation)(participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • Rate of Third and Fourth Degree Lacerations(At delivery)
  • Rate of Postpartum Hemorrhage(At delivery)
  • Neonatal Outcomes(At delivery)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alisse Hauspurg

Resident Physician

Women and Infants Hospital of Rhode Island

研究点 (2)

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