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临床试验/NCT03024905
NCT03024905已完成不适用

Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania

Bruyere Research Institute1 个研究点 分布在 1 个国家目标入组 17,000 人开始时间: 2017年1月16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
发起方
入组人数
17,000
试验地点
1
主要终点
Facility births

研究概览

简要总结

The purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.

详细描述

In order to reduce the number of women dying in childbirth and to improve women's health in pregnancy, this trial is designed to assess if several interventions combined can increase the number of women delivering in health care facilities. The design of the study is "Multiple Baseline Design". Community health workers are trained to collect baseline data on women using mobile phones in one rural district in Tanzania. The district has four distinct divisions. After 6 months of baseline data in the district, one division will experience the interventions. The interventions are education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and birthing supplies to be used either at the health facility, or on route if the women does not make it to the health facility. The intervention will be begun in each of the other divisions in 3 month intervals (i.e. the second division starts to experience the interventions 3 months after the first, the third, 3 months after the second and the fourth 3 months after the third). The trial will continue for a total of 27 months including the baseline period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 must be pregnant.
  • Women must live in Rorya District, but not in Shirati Town.
  • Women must deliver in Rorya District .

排除标准

  • Women who live outside or deliver outside of Rorya District.
  • Women who deliver preterm, before they have exposure to all the interventions.

研究组 & 干预措施

Division 1

Experimental

The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Village meeting and travel vouchers (Behavioral)

Division 1

Experimental

The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Birth kit with misoprostol (Device)

Division 2

Experimental

The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Village meeting and travel vouchers (Behavioral)

Division 2

Experimental

The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Birth kit with misoprostol (Device)

Division 3

Experimental

The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Village meeting and travel vouchers (Behavioral)

Division 3

Experimental

The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial.

Interventions are behavioural and device:

Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Birth kit with misoprostol (Device)

Division 4

Experimental

The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial.

nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Village meeting and travel vouchers (Behavioral)

Division 4

Experimental

The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial.

nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.

Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

干预措施: Birth kit with misoprostol (Device)

结局指标

主要结局

Facility births

时间窗: During baseline vs during intervention periods until end of study (2 years)

Number of women attending health facilities for delivery

次要结局

  • Antenatal Care visits(During baseline vs during intervention until end of study (2 years))
  • Use of transport intervention(During Intervention until end of study (2 years))
  • Postpartum visits(During baseline vs during intervention until end of study (2 years))
  • Use of birth kit(During Intervention until end of study (2 years))

研究者

发起方
Bruyere Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gail Webber

Associate Scientist

Bruyere Research Institute

研究点 (1)

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