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临床试验/NCT03509103
NCT03509103已完成不适用

Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh0 个研究点目标入组 1,012 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,012
主要终点
User rate of Electronic Partograph

研究概览

简要总结

Background (brief):

  1. Burden: Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. Although the partograph has been shown to be an efficacious tool for monitoring labor and identifying women in need of an comprehensive emergency obstetric intervention, it's appropriate use is questionable throughout the world. Evidence suggests that very few service provider use partograph despite recognizing its usefulness.
  2. Knowledge gap: In Bangladesh partograph is hardly used by the concern person though its importance and positive outcome is acknowledged at the national level. To introduce a digital partograph Johns Hopkins Program for International Education in Gynecology and Obstetrics (Jhpiego) developed an ePartogram device and WHO created partograph e-Learning tool. Jhpiego is currently testing three ePartogram implementations. However, till today, no data has been collected or analysed for any of these ePartogram models. The WHO e-Learning tool has been distributed to facilities like Kenyatta National Hospital via CD-ROM. In Kenya, a study also being conducted using a digital partograph (partopen) and results are yet to come.
  3. Relevance: The use of the paper partograph is found to be complex and too much time-consuming for effective use in low-resource settings where there has been inadequate health care staffing. These challenges highlight a need for strengthening providers' skills and/or developing new technologies that are suitable for low-resource countries and promote consistent, correct use of the partograph as well as, a labour monitoring system for the peripheral level health facilities. The benefits of this device are: ease of use, minimal training requirements, improved data quality and capture, and seamless integration into current local practice.

Objectives: The current study aims-

  1. To explore the feasibility, acceptability of digital partograph use among health service providers in selected district hospitals in Bangladesh;
  2. To compare the user rate between paper and digital partograph during labour monitoring process in district hospitals in Bangladesh;
  3. To compare the outcome of paper and digital partograph use in respect to the birth asphyxia and prolonged labour rate after introducing digital partograph in selected district hospitals in Bangladesh;
  4. To determine the barriers and facilitating factors of introducing electronic partograph in district hospital in Bangladesh.

Methods: A mixed-method prospective follow-up study with crossover design will be conducted in two DHs. One DH will serve as intervention (electronic partograph) hospital and another as control hospital (paper-based partograph). After applying the crossover design this allocation will be reversed. The total study will be completed within 18 months period. Nurse-midwives posted in obstetric wards will be the study participants. The sample size in each DH will be 506 mothers who will deliver their baby during the study period.

Outcome measures/variables:

  • Feasibility and acceptability of digital partograph use will be assessed among health service providers in selected DH in Bangladesh;
  • The user rate of digital partograph will be estimated during labour monitoring process in DHs in Bangladesh;
  • The birth asphyxia and prolonged labour rate will be estimated after introducing digital partograph in selected DHs in Bangladesh;
  • The barriers and facilitating factors of introducing electronic partograph will be determined in DHs in Bangladesh.

详细描述

Study design, site and duration:

A prospective, follow-up crossover study design was used. Two secondary level referral hospitals in Jessore and Kushtia districts were selected as study sites. The selected facilities were similar in terms of infrastructure, human resources, and service delivery scenarios to typical district hospitals and were thus representative of public hospitals in Bangladesh. However, there were a few differences in the number of c-section and stillbirth rates in between two study hospitals. The crossover study design adopted under this study was designed to minimize the impact of this non-similarity on the study outcomes. The same facility was served as its own control at different time point in time. The study was conducted in two phases with an intervening pause period. During the first phase, an electronic partograph was used in Kushtia district hospital and a paper based partograph was used in Jessore district hospital. Both of these hospitals were being crossed to alternate partograph tool after the pause period.

The nurse-midwives from each hospital posted in obstetric wards were the user who observed the calculated deliveries (N=506 for each facility) during the study period. Each participant attended a two-day long training to become acquainted with the respective partograph that they would be utilizing in the first phase of the study. Another training session was also arranged during the pause period. Clinical parameters recorded in the partograph were validated by the project appointed research assistants with midwifery qualifications who observed labor progression and deliveries.

Sample selection:

Sample size calculations were completed on the basis of existing prevalence of partograph use (17.1 %), and delivery outcome data related to paragraph use such as incidence of birth asphyxia (22%) and prolonged labour (7%) . Sample size calculations also took into account the refusal rate (10%) and design effects. Thus to observe the 50% improvement for all three mentioned clinical parameters (increased use of partograph, decreased level of birth asphyxia, and prolonged labour), the number of deliveries that needed to be observed were as follows, 105, 216 and 506 respectively at 80% power and 5% significance level. Thus the final sample size in each district hospital was taken as 506; half of the sample (253) before and the other half (253) after applying the crossover design. Field data collection continued for 12 months and the data collectors tried to capture all deliveries until the required minimum sample size was achieved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • women with spontaneous labour in the first stage of labour
  • cervical dilatation in between 4-7 centimeters
  • singleton pregnancy
  • gestation of at least 37 completed weeks
  • cephalic presentations
  • no additional complications

排除标准

  • women with ante partum hemorrhage
  • breech presentation,
  • multiple pregnancy,
  • premature labour (before 37 weeks)
  • Eclampsia,
  • elective caesarean section
  • induced labour

研究组 & 干预措施

Electronic partograph

Experimental

The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.

e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.

干预措施: Electronic Partograph (Other)

Paper Partograph

Active Comparator

An standard training on how to use and fill out partograph was conducted

干预措施: Electronic Partograph (Other)

结局指标

主要结局

User rate of Electronic Partograph

时间窗: 37 completed gestational weeks

Increased user rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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