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临床试验/NCT03612518
NCT03612518Unknown不适用

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

Junaid-ur-Rehman Siddiqui4 个研究点 分布在 1 个国家目标入组 970 人开始时间: 2018年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
970
试验地点
4
主要终点
Postpartum Contraceptive Uptake

研究概览

简要总结

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.

详细描述

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

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Text and Voice Messages

Experimental

Participants will receive text messages and voice messages

干预措施: Text and Voice Messages (Behavioral)

Interactive Phone Call

Experimental

Participants will receive interactive phone calls

干预措施: Interactive Phone Call (Behavioral)

Control

No Intervention

Participants in this arm will not be exposed to any intervention.

结局指标

主要结局

Postpartum Contraceptive Uptake

时间窗: 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

Immunisation

时间窗: Through study completion, an average of six months

Proportion of women reported to immunise the newborn at birth

Skilled Birth

时间窗: Through study completion, an average of six months

Proportion of women who gave birth in a health facility or through a skilled birth professional

次要结局

  • Intention to Adopt Modern Contraception(Through study completion, an average of six months)

研究者

发起方
Junaid-ur-Rehman Siddiqui
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Junaid-ur-Rehman Siddiqui

Principal Investigator

Marie Stopes Society

研究点 (4)

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