使用下一代产程仪可以改善新生儿结局吗？ （皮奇诺）
Can the Use of a Next Generation Partograph Based on WHO's Latest Intrapartum Care Recommendations Improve Neonatal Outcomes? A Stepped-wedge Cluster Randomized Trial (PICRINO)
The overall aim is to evaluate the impact of the use of two different guidelines for monitoring labor progress, the WHOs LCG versus standard care, on neonatal and maternal outcomes. The hypothesis is that the use of LCG will reduce adverse neonatal outcomes and decrease the number of intrapartum Cesarean sections compared with standard care.
Secondly, other perinatal interventions and complications will be compared between the LCG and standard care groups, as well as economic considerations. This will be investigated using a multicenter, stepped-wedge cluster randomized trial design.
In addition, the project will explore a series of quantitative and qualitative research questions to gain in-depth knowledge about experiences and perceptions about childbirth and the use of LCG. These research questions will be investigated using questionnaires, focus group and individual interviews with providers, partners and women that have gone through childbirth.
研究概览
详细说明
Study Title
Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? A stepped-wedge cluster randomized trial (PICRINO).
Primary Objectives
To compare two different guidelines for monitoring labor progress, the the World Health Organization (WHO)'s Labour Care Guide (LCG) with standard care, and evaluate:
Adverse neonatal outcome, a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score <7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.
The rate of intrapartum cesarean section.
Secondary Objectives
Secondary outcomes will be a composite of severe neonatal outcomes including five-minute Apgar score <4, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures and meconium aspiration syndrome and other relevant neonatal outcomes.
Obstetric outcomes will be mode of delivery, oxytocin use, postpartum hemorrhage, perineal laceration (grade II-IV), duration of labor, women´s and partner´s experiences of childbirth, healthcare providers experiences of and compliance to LCG and economic considerations.
Study Design
A multicenter, stepped-wedge cluster randomized trial.
Study Population
All women in active labor at participating delivery units in Sweden.
Power analysis
With significance level 0.05, the power to detect the anticipated risk reduction (20%) would be >0.999.
Study Duration
2023-2025
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Eksjö、瑞典
- Eksjö höglandssjukhuset
-
Falun、瑞典
- Falu Lasarett
-
Gothenburg、瑞典
- Göteborg Salgrenska Universitetssjukhuset
-
Gällivare、瑞典
- Gällivare sjukhus
-
Helsingborg、瑞典
- Helsingborgs lasarett
-
Huddinge、瑞典
- Huddinge Karolinska universitetssjukhus
-
Hudiksvall、瑞典
- Hudiksvalls sjukhus
-
Jönköping、瑞典
- Jönköping Länssjukhuset Ryhov
-
Kalmar、瑞典
- Länssjukhuset
-
Kristianstad、瑞典
- Kristianstad centralsjukhus
-
Linköping、瑞典
- Linköpings universitetssjukhus
-
Lund、瑞典
- Lund Skånes universitetssjukhus
-
Skellefteå、瑞典
- Skellefteå Lasarett
-
Stockholm、瑞典
- BB Stockholm
-
Stockholm、瑞典
- Stockholm Södersjukhuset
-
Södertälje、瑞典
- Södertälje Sjukhus
-
Södra Sunderbyn、瑞典
- Sunderby sjukhus
-
Umeå、瑞典
- Umeå Norrlands universitetssjukhus
-
Uppsala、瑞典
- Akademiska sjukhuset
-
Visby、瑞典
- Visby Lasarett
-
Värnamo、瑞典
- Värnamo sjukhus
-
Västervik、瑞典
- Västerviks sjukhus
-
Ystad、瑞典
- Ystad Lasarett
-
-
Östergötland County
-
Norrköping、Östergötland County、瑞典
- Vrinnevisjukhuset
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-All women in active labor
Exclusion Criteria:
-No exclusion criteria
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Labour care guide
According to WHO guidelines |
Guidelines for monitoring labor progress, the WHOs LCG |
|
无干预：Standard care
Standard delivery care in Sweden |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse neonatal outcome
大体时间：12 weeks up to 18 months
|
a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score <7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit. |
12 weeks up to 18 months
|
|
The rate of intrapartum cesarean section
大体时间：12 weeks up to 18 months
|
The rate of intrapartum cesarean section |
12 weeks up to 18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neonatal outcomes
大体时间：12 weeks up to 18 months
|
Five-minute Apgar score <7 admission to neonatal unit Hypoxic ischemic encephalopathy II-III Intracranial hemorrhage Neonatal seizures Meconium aspiration syndrome Five-minute Apgar score <4 Perinatal mortality neonatal mortality Neonatal infection Neonatal hypoglycemia Neonatal jaundice Shoulder dystocia Obstetric brachial plexus injury |
12 weeks up to 18 months
|
|
Obstetric outcomes
大体时间：12 weeks up to 18 months
|
Rates of spontaneous vaginal delivery Rates of instrumental delivery Indications for intrapartum cesarean section Rates of oxytocin use for augmentation of labor Cervical dilation at onset of augmentation (centimeters) Rates of adherence to oxytocin use recommendations Rates of epidural use Amount of postpartum bleeding, ml Rates of perineal laceration (grade II-IV) Duration of labor, minutes |
12 weeks up to 18 months
|
|
Childbirth experience (women and partners)
大体时间：12 weeks up to 18 months
|
interviews questionaries |
12 weeks up to 18 months
|
|
Provider experience of LCG
大体时间：12 weeks up to 18 months
|
interviews |
12 weeks up to 18 months
|
|
Economic evaluation
大体时间：12 weeks up to 18 months
|
Data on health care utilization for women Data on health care utilization for children |
12 weeks up to 18 months
|
合作者和调查者
调查人员
- 首席研究员：Marie Blomberg, Professor、Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
出版物和有用的链接
一般刊物
- WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
- Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.
- Sjoberg J, Ramo Isgren A, Abrahamsson T, Blomberg M, Thomas K. Associations between organizational readiness and implementation fidelity in national implementation of WHO's labour care guide in Sweden: a prospective observational study. Implement Sci Commun. 2026 Aug 14;7(1):165. doi: 10.1186/s43058-026-01073-z.
- Isgren AR, Korsoski R, Abrahamsson T, Wendel SB, Kallen K, Lundborg L, Remaeus K, Thomas K, Wikstrom AK, Carlsson Y, Blomberg M. Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? (PICRINO) Study protocol for a stepped-wedge cluster randomized trial. PLoS One. 2025 Mar 4;20(3):e0316336. doi: 10.1371/journal.pone.0316336. eCollection 2025.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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