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An mHealth Trial to Promote the Use of Postpartum Contraception (PPFP)

2018年8月1日 更新者:Junaid-ur-Rehman Siddiqui

An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan

Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.

研究概览

详细说明

The study will be a three-arm, 10-month, multicentre, parallel-group, randomized controlled trial which will be conducted at 15 Suraj social franchise(SF) health facilities in Punjab province of Pakistan. Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study. The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support). The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan. It will broadly cover birth-preparedness, birth spacing and contraception, and postnatal care. The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods. Risk differences will be used as the measure of effect of the intervention on the outcomes.

研究类型

介入性

注册 (预期的)

970

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Punjab
      • Hafizabad、Punjab、巴基斯坦
        • Suraj Social Franchise
      • Jhang、Punjab、巴基斯坦
        • Suraj Social Franchise
      • Kasur、Punjab、巴基斯坦
        • Suraj Social Franchise
      • Toba Tek Singh、Punjab、巴基斯坦
        • Suraj Social Franchise

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 至 44年 (孩子、成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Married
  • Pregnant women with gestational age up to 20 weeks
  • 15-44 years old throughout duration of study
  • Literate
  • Access to a cellphone
  • Living in the study's catchment area

Exclusion Criteria:

  • Not up to 20 weeks pregnant
  • Not between 15-44 years old for the study duration
  • Illiterate
  • Does not have regular access to a cellphone
  • Not residing within the catchment area
  • Does not provide consent to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 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:Text and Voice Messages
Participants will receive text messages and voice messages
Participants in this study arm will periodically receive information regarding antenatal- and postnatal care and family planning services through text and voice messages from the fifth gestational month until the post-partum period of 42 days.
实验性的:Interactive Phone Call
Participants will receive interactive phone calls
Participants in this study arm will receive information regarding antenatal- and postnatal care and family planning services through periodic interactive phone calls from the fifth gestational month until the post-partum period.
无干预:Control
Participants in this arm will not be exposed to any intervention.

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
Postpartum Contraceptive Uptake
大体时间:Through study completion, an average of six months
Proportion of subjects enrolled in each of the three groups who adopt any modern family planning method to delay next pregnancy
Through study completion, an average of six months
Skilled Birth
大体时间:Through study completion, an average of six months
Proportion of women who gave birth in a health facility or through a skilled birth professional
Through study completion, an average of six months
Immunisation
大体时间:Through study completion, an average of six months
Proportion of women reported to immunise the newborn at birth
Through study completion, an average of six months

次要结果测量

结果测量
措施说明
大体时间
Intention to Adopt Modern Contraception
大体时间:Through study completion, an average of six months
The proportion of subjects enrolled in the program who state that they intend to adopt any modern family planning method to delay their next birth by 24 months (by type contraceptive method and time within 42 days of postpartum period)
Through study completion, an average of six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Xaher Gul, DrPH(c)、Marie Stopes Society
  • 首席研究员:Waqas Hameed, MSc、Marie Stopes Society
  • 首席研究员:Junaid-ur-Rehman Siddiqui, BBA、Marie Stopes Society
  • 首席研究员:Sharmeen Hussain, MPH、Marie Stopes Society
  • 首席研究员:Ishaque Sheikh, MSc、Marie Stopes Society

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2018年9月15日

初级完成 (预期的)

2019年8月1日

研究完成 (预期的)

2019年8月1日

研究注册日期

首次提交

2018年7月27日

首先提交符合 QC 标准的

2018年8月1日

首次发布 (实际的)

2018年8月2日

研究记录更新

最后更新发布 (实际的)

2018年8月2日

上次提交的符合 QC 标准的更新

2018年8月1日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 009-17

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

IPD will only be shared for underlying results in a publication. Furthermore, de-identified participant data pertinent only to the research paper will be shared.

IPD 共享时间框架

Publication

IPD 共享访问标准

At the time of publication, data will be submitted to a data repository and the URL will be shared with the journal, and the journal will make the information public. Requests to access data will be individually reviewed by the research team.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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