The PartoMa Project for Saving Lives at Birth - An Intervention Based Study to Strengthen the Quality of Monitoring, Action and Triage During Labour at an East African Referral Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,087
- 试验地点
- 1
- 主要终点
- Composite outcome of stillbirths and birth asphyxia
研究概览
简要总结
OVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of locally agreed and achievable guidelines and a continual in-house training program for strengthening partogram-based monitoring-to-action during labour.
INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the PartoMa guidelines) and continual in-house education.
OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study).
SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.
POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after unset of labour and followed until discharge.
ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further description and secondary outcomes, please see below.
STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit collection of case file data from October 2016 - January 2017.
详细描述
SPECIFIC OBJECTIVES
I (a) To analyze in depth current quality of intrapartum care by a mixed methods approach, including exploration of underlying challenges in care delivery and an association between suboptimal labour care and perinatal mortality. (b) To conduct a criterion-based audit of stillbirths investigating direct and indirect causes and related maternal risks.
II. To develop locally achievable and agreed partogram-associated labour monitoring-to-action guidelines (the PartoMa guidelines) for strengthening the partogram use as a decision support tool, and study its acceptability by skilled birth attendants.
III. To implement the PartoMa guidelines and low cost, low dose, high frequency, in-house training for strengthening the use of the partogram as a decision support tool, and study the effect on knowledge, skills, quality of intrapartum care, record keeping, and perinatal outcome.
IV. To conduct a post-exit 2 years evaluation of use and effect of the PartoMa guidelines and recurring training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All women in labour delivering at the study site and their outcome, October 2014 - January 2015 and October 2015 - January 2016
- •All health care providers at the department during the baseline and intervention period, October 2014 - January 2016
- •For the different substudies, sub-groups are selected (please see the secondary outcomes for a description).
排除标准
- 未提供
研究组 & 干预措施
Health care providers
All health care providers (physicians and nurse-midwives) working at the Department of Obstetrics during the study period will be invited to participate in knowledge tests of obstetric care and qualitative participant observations as well as in-depth interviews regarding quality of care. This is a part of evaluating the use and effectiveness of the PartoMa intervention.
干预措施: The PartoMa intervention (Other)
Women in labour
All women in labour during the study period (4 months baseline and the 9th-12th month of the intervention) will be included for this pre- vs. post-study of the PartoMa intervention.
The following subgroups will be studied in-depth:
- All stillbirths
- All maternal deaths
- All women with severe hypertensive disorders
- A randomized selected group of women delivering a the study site, approximately 300-600 each year.
干预措施: The PartoMa intervention (Other)
结局指标
主要结局
Composite outcome of stillbirths and birth asphyxia
时间窗: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Stillbirths (=late foetal deaths \>=1000g), subdivided into pre- and intra-hospital stillbirths (with/without positive foetal heart rate on admission). Birth asphyxia was defined as newborns with a 5-minutes Apgar score \< 6.
次要结局
- Cesarean sections and vacuum extractions(A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).)
- Health providers' perception of their work situation in the labour and delivery rooms(This is assessed at multiple time points throughout the study period and more in-depth after 2 years of the intervention.)
- The women's experience of care received during delivery.(This is assessed through community visits in January - March 2016.)
- HALE(This will be evaluated economically after finalizing the study period.)
- Maternal death(A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).)
- Process indicators of quality of intrapartum labour care(A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).)
研究者
Ib Christian Bygbjerg
Professor
University of Copenhagen