Fixed-time Interval vs. On-demand Analgesia Following Vacuum-assisted Vaginal Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum
研究概览
简要总结
This randomized controlled trial evaluates the effectiveness of scheduled versus on-demand pain relief protocols in managing postpartum pain during the first 24 hours after vacuum-assisted delivery.
Objectives:
Primary: Compare pain reduction (VAS scores) between the two protocols. Secondary: Assess extended pain relief use, breastfeeding rates, maternal satisfaction, and postpartum hospitalization duration.
Design:
Participants: 200 women aged 18-45, randomized into two groups:
Scheduled Pain Relief: Acetaminophen and diclofenac every 8 hours. On-Demand Pain Relief: Same medications administered upon request. Pain levels are assessed via VAS every 8 hours and around medication times. All participants receive IV acetaminophen immediately postpartum and additional pain relief for breakthrough pain as needed.
Data Collection: Demographics, delivery details, pain scores, medication use, breastfeeding rates, and satisfaction (using the Birth Satisfaction Scale-BSS-R) will be recorded.
Significance: The study aims to fill a gap in the literature on postpartum pain management for vacuum-assisted deliveries, improving care and maternal outcomes.
详细描述
Study Objectives:
- Primary Objective: Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).
- Secondary Objectives:
- Measure VAS scores every 8 hours during the first 24 hours postpartum.
- Assess the use of pain relief beyond 24 hours postpartum, including the use of morphine.
- Evaluate breastfeeding rates, satisfaction with the birth experience, and length of postpartum hospitalization.
Study Design:
- Recruitment: Women will be recruited immediately after vacuum-assisted delivery.
- Participants will provide informed consent and be assigned a unique anonymous identifier for data collection.
- All participants will receive 1,000 mg of IV acetaminophen immediately postpartum, per departmental protocol.
- Participants will be randomized (1:1) into two groups:
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.
排除标准
- •Allergy to acetaminophen or NSAIDs.
- •Chronic pain conditions (e.g., endometriosis, fibromyalgia).
- •Cesarean deliveries.
- •Multiple pregnancies.
- •Normal vaginal delivery.
研究组 & 干预措施
Scheduled Pain Relief
Scheduled Pain Relief
干预措施: Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours. (Drug)
On-Demand Pain Relief Group
pain relief drug by request
干预措施: On demand analgesia (Other)
结局指标
主要结局
Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum
时间窗: From enrollment until discharge following delivery, up to 1 week.
Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).
次要结局
- Pain relif use, hospitalization, breastfeeding and maternal satisfaction.(From enrollment until discharge following delivery, up to 1 week.)
- Baseline maternal and obstetric characteristics(From enrollment until discharge following delivery, up to 1 week.)
- Labor and delivery characteristics(From enrollment until discharge following delivery, up to 1 week.)
- Delivery outcomes and maternal complications(From enrollment until discharge following delivery, up to 1 week.)
研究者
Yael Yagur
Dr Yael Yagur
Meir Medical Center