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Education of Pregnant Women With a Prenatal Indication for Cesarean Section Through Periodic Short Message Service (SMS) and Interactive Voice Response System (IVR) in Uganda

2026年7月6日 更新者:Adeline A Boatin、Massachusetts General Hospital

Women with antenatally identified indications for planned pre-labor cesarean delivery in low-resource settings frequently present in labor before their scheduled delivery, resulting in emergency cesarean delivery and increased maternal and neonatal risk. Contributing factors include limited continuity of care between antenatal and intrapartum services and insufficient cesarean-specific birth preparedness counseling.

This prospective pilot study evaluated the feasibility and acceptability of a mobile health (mHealth) educational intervention using Short Message Service (SMS) and Interactive Voice Response (IVR) to support birth preparedness among pregnant women with antenatal indications for planned pre-labor cesarean delivery receiving care at Mbarara Regional Referral Hospital in Uganda. Participants received automated educational SMS and IVR messages in English or Runyankole at 14, 7, and 2 days before their scheduled cesarean delivery. Message content focused on timing of delivery, recognition of warning signs, logistical planning, and perioperative preparation.

The primary objectives were to evaluate the feasibility of delivering SMS and IVR messages to high-risk pregnant women and the acceptability of the intervention among participants. Findings from this pilot are intended to inform the development and future evaluation of larger mHealth interventions designed to improve continuity of care and preparedness for planned cesarean delivery in low-resource settings.

研究概览

详细说明

Planned pre-labor cesarean delivery is recommended for several antenatally identified obstetric conditions to reduce maternal and neonatal morbidity associated with labor. In many low-resource settings, however, women with known indications for planned cesarean delivery frequently present after labor has begun, resulting in emergency cesarean delivery. Strengthening continuity of care between antenatal care and delivery through standardized patient education may improve preparedness for scheduled delivery.

This prospective, single-arm pilot study evaluated the feasibility and acceptability of a mobile health (mHealth) educational intervention using Short Message Service (SMS) and Interactive Voice Response (IVR) among pregnant women with antenatal indications for planned pre-labor cesarean delivery receiving care at Mbarara Regional Referral Hospital in southwestern Uganda.

Eligible participants were pregnant women between 28 and less than 39 weeks' gestation who had a clinician-determined indication for planned pre-labor cesarean delivery, intended to deliver at Mbarara Regional Referral Hospital, had access to a mobile phone within their household or community, and were able to provide informed consent in English or Runyankole. Women with signs of labor or obstetric complications requiring immediate delivery at enrollment were excluded.

The intervention consisted of automated educational SMS and IVR messages delivered through the EngageSpark platform in the participant's preferred language. Messages were scheduled approximately 14, 7, and 2 days before the planned cesarean delivery date. Educational content included:

Recommended timing of planned cesarean delivery Recognition of maternal danger signs requiring urgent evaluation Transportation and financial planning for delivery Family and caregiver preparation Perioperative expectations and preparation for cesarean delivery

Participants were scheduled to receive one IVR message at each time point. Two SMS messages were delivered at the 14-day and 7-day time points, and one SMS message at the 2-day time point. Participants could request follow-up telephone contact if additional clarification was needed. Message delivery and IVR engagement were monitored using automated platform data.

The primary objectives were to evaluate implementation outcomes related to feasibility and acceptability. Feasibility outcomes included successful message delivery, participant-reported receipt of messages, and engagement with IVR messages measured by call duration. Acceptability outcomes included participant preferences regarding message modality, timing and frequency of delivery, perceived usefulness, comprehension, satisfaction, and barriers to intervention use. Digital readiness and mobile phone access were also assessed to explore implementation across varying levels of digital access.

This pilot study was intended to generate implementation data to refine the intervention and inform the design of future effectiveness studies evaluating the impact of mHealth-supported birth preparedness on timely presentation for planned cesarean delivery and maternal and neonatal outcomes.

研究类型

介入性

注册 (实际的)

71

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

      • Mbarara、乌干达
        • Mbarara Regional Referral Hospital

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Pregnant women between ≥28 weeks and <39 weeks' gestation Receiving antenatal care at Mbarara Regional Referral Hospital (MRRH), Uganda Planning to deliver at MRRH Known gestational age

Antenatally identified by a clinician as having an indication for planned pre-labor cesarean delivery, including:

Two or more prior cesarean deliveries Prior classical cesarean delivery Prior myomectomy Prior uterine rupture Persistent breech presentation Access to a mobile phone (personal, household, or community) Able to provide informed consent Able to communicate in English or Runyankole

Exclusion Criteria:

  • Signs or symptoms of labor at enrollment Obstetric complications requiring immediate evaluation or delivery No access to a mobile phone Unable to communicate in English or Runyankole

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:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 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:SMS and IVR Educational Intervention
Participants received the SMS and Interactive Voice Response (IVR) educational intervention in addition to routine antenatal care. Automated educational messages were delivered in English or Runyankole approximately 14, 7, and 2 days before the participant's scheduled pre-labor cesarean delivery. Message content provided reminders of planned cesarean dates and reinforced routine antenatal counseling and included information on timing of delivery, recognition of maternal danger signs, transportation and financial planning, family preparation, and perioperative expectations. Participants continued to receive all standard clinical care throughout the stud
Participants received an automated educational intervention delivered through Short Message Service (SMS) and Interactive Voice Response (IVR) in English or Runyankole. Messages were scheduled approximately 14, 7, and 2 days before each participant's planned pre-labor cesarean delivery and reinforced routine antenatal counseling. Educational content included the recommended timing of delivery, recognition of maternal danger signs requiring urgent evaluation, transportation and financial planning, family preparation, and perioperative expectations for cesarean delivery. Participants received one IVR message at each scheduled time point, two SMS messages at the 14- and 7-day time points, and one SMS message at the 2-day time point. Participants continued to receive routine antenatal care throughout the study

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
Successful delivery of SMS and IVR messages
大体时间:14, 7, and 2 days before scheduled cesarean delivery
Proportion of scheduled SMS and IVR messages successfully delivered to participants, as confirmed by the messaging platform. Delivery was assessed among participants who remained pregnant and eligible to receive messages at each scheduled time point.
14, 7, and 2 days before scheduled cesarean delivery
Participant acceptability of SMS and IVR messages
大体时间:Post-delivery, before hospital discharge or 1 to 2 weeks after scheduled delivery date
Proportion of participants reporting that the SMS and IVR messages were understandable, useful, satisfactory, and acceptable based on a post-delivery acceptability questionnaire
Post-delivery, before hospital discharge or 1 to 2 weeks after scheduled delivery date

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:Adeline A Boatin, MD MPH、Massachusetts General Hospital

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 (实际的)

2024年6月11日

初级完成 (实际的)

2025年4月17日

研究完成 (实际的)

2025年6月30日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

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

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request to the study investigators, subject to institutional approvals, execution of an appropriate data use agreement, and applicable ethical and regulatory requirements.

IPD 共享时间框架

12 months after publication of the primary manuscript

IPD 共享访问标准

Available to qualified researchers who submit a methodologically sound proposal and execute a data use agreement, subject to institutional and ethics approvals

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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