Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

6. juli 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

71

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Mbarara, Uganda
        • Mbarara Regional Referral Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful delivery of SMS and IVR messages
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Adeline A Boatin, MD MPH, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. juni 2024

Primær færdiggørelse (Faktiske)

17. april 2025

Studieafslutning (Faktiske)

30. juni 2025

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

12 months after publication of the primary manuscript

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner