Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

71

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Mbarara, Uganda
        • Mbarara Regional Referral Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Successful delivery of SMS and IVR messages
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Adeline A Boatin, MD MPH, Massachusetts General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. Juni 2024

Primärer Abschluss (Tatsächlich)

17. April 2025

Studienabschluss (Tatsächlich)

30. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

12 months after publication of the primary manuscript

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren