Telemonitoring for High-risk Pregnancies in an International Context (PregnaDigit EU): a Hybrid Type 2 Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- UMC Utrecht
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Implementation outcome: Proctor Penetration
研究概览
简要总结
Pregnancy care is under increasing pressure due to a rising number of women needing medical care, a shortage of obstetric healthcare professionals, and growing healthcare costs. For women with high-risk pregnancies, this often leads to frequent hospital visits or admissions for monitoring, which can be stressful and time consuming. Remote digital care offers a promising alternative by allowing pregnant individuals to perform monitoring from home while remaining under medical supervision.
This study will evaluate the use of telemonitoring in pregnancy care in four European hospitals. Participants with high-risk pregnancies who require frequent cardiotocography (CTG) monitoring and blood pressure (BP) measurements will use certified home devices to record fetal and maternal health data. Instead of hospital-based monitoring, CTG and BP measurements will be performed at home and assessed by trained healthcare professionals.
The main purpose of the study is to investigate whether home monitoring is a safe and acceptable alternative to in-hospital monitoring, and to identify what is needed for successful national and international implementation of remote digital pregnancy care. The investigators will collect clinical and implementation outcomes. By doing so, this study aims to keep pregnancy care accessible for all women, improve patient well-being, and reduce pressure on the healthcare system.
详细描述
This study investigates the implementation and effectiveness of telemonitoring using cardiotocography (CTG) and blood pressure (BP) home monitoring in four European academic hospitals. RDPC allows pregnant individuals with high-risk complications to conduct CTG recordings at home, which are then reviewed by trained obstetric healthcare providers through secure digital platforms. This approach has the potential to replace hospital-based monitoring, reduce healthcare consumption, and improve patient well-being while maintaining safety.
The study is conducted in four tertiary referral centers for obstetric care: University Medical Center Utrecht and Erasmus Medical Center in the Netherlands, Vall d'Hebron University Hospital in Spain, and Karolinska University Hospital in Sweden. These hospitals serve large and diverse populations and have extensive experience with managing high-risk pregnancies, providing an international perspective on the implementation and effectiveness of RDPC.
Telemonitoring will be conducted with CE-certified CTG devices (PregnaBit Pro with PregnaOne Platform or Mosos CTG by ICT/HCTS, or the Nemo fetal monitoring system by Nemo Healthcare), and in some centers, blood pressure will be monitored using Microlife WatchBP devices. All devices are CE-certified and not classified as investigational products in this study.
The study follows a hybrid type 2 implementation-effectiveness design. First, this study will assess clinical outcomes of participants undergoing telemonitoring. The study will investigate adverse maternal and perinatal outcomes to ensure that home monitoring is a safe alternative to hospital-based care. To further assess the clinical effectiveness of telemonitoring, investigators will evaluate health care consumption of pregnant participants during telemonitoring, such as the number of days each participant received telemonitoring and number and indications of unplanned hospital visits and admissions. These data will provide insight into the health care demands associated with the telemonitoring care pathways. These measures will provide valuable insights into the efficiency and scalability of telemonitoring.
In addition to clinical outcomes, this study will evaluate implementation outcomes across three sequential phases: pre-implementation, implementation, and post-implementation. Outcomes are based on the taxonomy of Proctor et al., including acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration, and sustainability. Implementation data will be collected from patients and obstetric healthcare professionals, and hospital systems through questionnaires, interviews, and structured data analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •A singleton pregnancy of ≥26+0 weeks of gestation (UMCU, EMC, and Vall d'Hebron) or ≥24+0 weeks of gestation (Karolinska)
- •Able to give informed consent.
- •Proficiency in English or the local language (Dutch, Spanish or Swedish)
- •The presence of a complication requiring CTG monitoring according to local protocol
排除标准
- •Pregnancy complications requiring intravenous (IV) anti-hypertensive therapy
- •Expected obstetric intervention within 48 hours
- •Current blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic
- •Active antepartum hemorrhage
- •CTG abnormalities suggestive of fetal stress or hypoxia
- •Residence located more than a 30-minute drive from any hospital (not necessarily the hospital initiating home monitoring)
- •Presence of an implanted medical device (e.g. pacemaker)
结局指标
主要结局
Implementation outcome: Proctor Penetration
时间窗: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Penetration: The integration of telemonitoring in the hospital. Assessment method by questionnaire.
Implementation outcome: Proctor Sustainability
时间窗: Depending on each site and participant questionnaires are send out in 2025. Percentage: Whole study duration up untill the end of data analysis Feb 2028
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Sustainability:The extent to which the use of telemonitoring is maintained within the hospital during and after the implementation phase. Assessment method: questionnaire and the percentage of centers that continued with telemonitoring after the implementation phase.
Clinical outcome: composite of adverse perinatal and maternal events
时间窗: During pregnancy up to six months postpartum
The primary clinical outcome is a composite measure of adverse perinatal and maternal events. This dichotomous composite is defined as the occurrence of one or more of the following: * Perinatal mortality (maternal, fetal, or neonatal) * Low neonatal condition at birth: 5-minute Apgar score \< 7 and/or arterial cord blood pH \< 7.05 * Maternal morbidity, including one or more of: Hypertensive crisis requiring intravenous antihypertensive medication and/or MgSO4 for eclampsia prevention Eclampsia (new-onset, generalized tonic-clonic seizures or coma in a woman with preeclampsia) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) Venous thromboembolism (deep vein thrombosis or pulmonary embolism) Maternal admission to an Intensive Care Unit (ICU) Admission of the newborn to a Neonatal Intensive Care Unit (NICU) ≥ 24 hours -Caesarean section.
Implementation outcome: Proctor Acceptability
时间窗: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Questionnaire pregnant participants: 5 days after starting telemonitoring. Depending on each site and participant questionnaires are send out in 2025.
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Acceptability: The perception that telemonitoring is agreeable, palatable or satisfactory among obstetric healthcare providers and pregnant participants. Assessment method is by questionnaires.
Implementation outcome: Proctor Adoption
时间窗: Qualitative analysis of semi-structures interviews: pre-implementation phase (dec-jan 2025)Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase (2025).
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Adoption: The intention to start telemonitoring among obstetric healthcare providers. Assessment method: qualitative analysis of semi-structured interviews and questionnaire.
Implementation outcome: Proctor Appropriateness
时间窗: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Appropriateness: The perceived fit, relevance, or compatibility of telemonitoring among obstetric healthcare providers and pregnant participants.. Assessment method: questionnaire.
Implementation outcome: Proctor Costs
时间窗: Whole study duration up untill the end of data analysis Feb 2028
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Costs: The cost impact analysis of telemonitoring. Assessment method: Metro Maps and Time Driven Activity Based Costing (TDABC)
Implementation outcome: Proctor Feasibility
时间窗: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Feasibility: The extent to which telemonitoring can be successfully used or carried out within the hospital by obstetric healthcare providers. Assessment method is by questionnaires.
Implementation outcome: Proctor Fidelity
时间窗: Whole study duration up untill the end of data analysis Feb 2028
Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Fidelity: The extent to which telemonitoring is implemented as it was described in the original protocol. Assessment method: Number of wrongful inclusions, eligbile patients missed, adherence to the predefined protocol.
次要结局
- Clinical outcome: All individual components of the primary, composite outcome(During pregnancy up to six months postpartum)
- Clinical outcome: Adverse perinatal event: Umbilical Cord Prolapse(During pregnancy and labour)
- Clinical outcome: Adverse perinatal event: Intrauterine infection requiring antibiotic treatment(During pregnancy up to six months postpartum)
- Clinical outcome: Healthcare consumption(During telemonitoring: average 11 days during pregnancy)