NCT07696325

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

mhealthbirth preparednessplanned cesarean deliverySMSinteractive voice responseprenatal educationintrapartum planning

Outcome Measures

Primary Outcomes (2)

  • Successful delivery of SMS and IVR messages

    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

    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

Study Arms (1)

SMS and IVR Educational Intervention

EXPERIMENTAL

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

Behavioral: SMS and Interactive Voice Response (IVR) Educational Intervention

Interventions

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

SMS and IVR Educational Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

MeSH Terms

Interventions

Spermine Synthase

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Adeline A Boatin, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This was a prospective, single-arm pilot study. All enrolled participants received the SMS and IVR educational intervention in addition to routine antenatal care. No comparison or control group was included. The study was designed to evaluate the feasibility and acceptability of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Investigator

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

June 11, 2024

Primary Completion

April 17, 2025

Study Completion

June 30, 2025

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
12 months after publication of the primary manuscript
Access Criteria
Available to qualified researchers who submit a methodologically sound proposal and execute a data use agreement, subject to institutional and ethics approvals

Locations