跳至主要内容
临床试验/NCT06636149
NCT06636149招募中不适用

CIRCUIT: Maternal Maneuvers During Prolonged Labor, A Pilot Randomized Control Trial

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
82
试验地点
1
主要终点
First stage of labor duration

研究概览

简要总结

This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor.

Patient who have prolonged labor will be approached for consent and randomization to one of two study groups: circuit intervention against routine standard of care position changes. 82 patients will be enrolled in the study. Exclusion criteria will include: any uterine infection prior to randomization, magnesium sulfate treatment, major fetal anomalies, BMI ≥50, non-reassuring fetal status prior to randomization, or any maternal diagnosis that precludes safety or feasibility of the circuit of maternal position changes.

The 3 aims of the study will include: the outcome that the circuit of position changes has on the duration of the first stage of labor, maternal and neonatal morbidity, and maternal satisfaction.

详细描述

To date, there is an absence of data on intrapartum maternal position changes' efficacy or whether a specific circuit of intrapartum maneuvers is effective. We hypothesize that a nurse-informed circuit of positional maneuvers in protracted labor will significantly decrease the first stage of labor. The objective of this randomized control trial will be to assess whether a specific circuit of maternal position changes in prolonged latent or active labor will decrease the first stage of labor length. The three aims of this study are as follows: determine the effect of a nurse-led circuit of maternal position changes versus routine care on first stage of labor duration in patients with protracted labor. Compare maternal and neonatal outcomes among those with protracted labor who undergo a nurse-led circuit of maternal position changes vs routine standard of care. Compare maternal satisfaction, sense of control over labor process, and acceptability of a circuit of maternal position changes for those who undergo a nurse-led circuit of maternal position changes vs routine standard of care.

Across the country, there is an emphasis to reduce cesarean delivery rates with a specific focus on reducing rates of primary cesarean deliveries in nulliparous, term, singleton, and vertex pregnancies. The most common indication for a primary cesarean delivery is labor arrest. As a possible solution, there has been an increased utilization of maternal position changes during labor. In some cases, these are specifically used in cases of a prolonged first stage of labor. While these specific position changes are likely not associated with maternal or fetal harm, they require significant buy in from nursing and labor and delivery staff. Not only is increased time at the bedside required to execute these maneuvers, but they also often require multiple members of the care team, especially in patients with epidurals or obesity. To date, no study, retrospective or prospective, has evaluated the efficacy of a specific set of maternal maneuvers during prolonged first stage of labor. If a specific circuit of maternal maneuvers is found to decrease the first stage of labor duration in cases of protracted labor, then this would represent a significant intervention that could be offered to improve labor outcomes in patients.

This study's aim is to evaluate if, in cases of a prolonged first stage of labor, a specific circuit of maternal position changes leads to shorter first stage of labor duration. The study will be a prospective, randomized, pilot trial that will be conducted at Barnes Jewish Hospital in St. Louis, Missouri. This trial design was selected to minimize confounding factors and study the effects of a circuit of maternal position changes as specifically as possible. This trial will represent the first of its type to prospectively study the benefits of maternal position changes in cases of protracted labor.

This study's inclusion and exclusion criteria are listed later in this submission. Patients will be approached, enrolled, and consented to participate upon their admission to Labor and Delivery or when they have a diagnosis of protracted labor. Randomization will occur once they meet study criteria for protracted labor. Randomization will be done via a computer-generated block randomization sequence in a 1:1 ratio of the RN-led circuit of maternal maneuvers versus routine care during the remaining portion of the patient's labor course. Blinding will not be possible for the nursing team or physician team caring for patient. Data collection reviewers will be blinded to the participant's randomization arm.

Patients will be either randomized to routine care or a maternal circuit of labor position changes. These arms are described in detail later in the submission.

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 (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English-speaking patients
  • Singleton, vertex pregnancies
  • 34 weeks' gestation or later
  • Admitted to Labor and Delivery in spontaneous labor or for an induction of labor
  • Prolonged labor course as defined by: cervical dilation less than 6 cm after 8 hours or more of ruptured membranes (spontaneous or artificial) and oxytocin infusion, or cervical dilation 6 cm or more and less than 1-cm cervical dilation change over 2 hours or more with ruptured membranes and oxytocin infusion

排除标准

  • Intraamniotic infection prior to randomization
  • Magnesium sulfate treatment
  • Major fetal anomalies
  • Non-reassuring fetal status prior to randomization
  • Any maternal diagnosis that precludes safety or feasibility of intrapartum circuit of maternal position changes

研究组 & 干预措施

Circuit Intervention Arm

Experimental

The intervention cohort will undergo the circuit of position changes every 2 hours. The circuit will be repeated up to 3 times or until the second stage of labor is achieved, delivery occurs, or labor arrest diagnosis is made. Participants will be considered as adherent to intervention arm if they undergo one complete circuit of maneuvers. Nurses will keep patients on continuous fetal monitoring during the circuit of position changes. Any persistent non-reassuring fetal status in one position of the circuit will prompt progression to the next position in the circuit. The planned circuit of maneuvers will be: 10-minutes of side-lying release on one side 10-minutes of side-lying release on other side 10-minutes of open-knee chest 10-minutes of shaking apples 20-minutes of flying cowgirl on one side 20-minutes of flying cowgirl on opposite side as position 5 20-minutes of running man on same side as position 5 20-minutes of running man on opposite side as position 5

干预措施: Circuit of maternal position changes during labor (Other)

Control Arm

No Intervention

Patients randomized to the control arm will have their labor courses managed per current best practice recommendations. This will include nurse or patient facilitated position changes per the discretion of the patient's clinical care team. Routine position changes allowed in this control group will include walking, sitting, squatting, thrones, supine, hands and knees, and lateral decubitus with or without peanut ball. No positions in the circuit intervention group will be permitted to be used in the control group. Any circuit positions used in the control group will be tracked and documented.

结局指标

主要结局

First stage of labor duration

时间窗: From enrollment until delivery

Time from first cervical exam in spontaneous labor or first induction agent administration for induction of labor until patient has achieved cervical dilation of 10cm.

次要结局

  • Mode of delivery(Enrollment to delivery)
  • Cesarean section indication(Enrollment to delivery)
  • Length of labor(Enrollment to delivery)
  • Length of active labor(Time from 6cm of cervical dilation to 10cm of cervical dilation or delivery)
  • Length of latent labor(Admission until active labor (cervix 6cm or greater) or delivery)
  • Length of second stage of labor(10cm of cervical dilation to delivery)
  • Time from randomization to delivery(Time from randomization to delivery)
  • Time from randomization to second stage of labor(Time from randomization until patient achieves 10cm cervical dilation)
  • Composite maternal morbidity(Enrollment to postpartum discharge)
  • Composite Neonatal Morbidity(From delivery until neonatal discharge or 1 month of life (whichever comes first))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Drew Hensel

Physician, Fellow - Maternal Fetal Medicine

Barnes-Jewish Hospital

研究点 (1)

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