- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07696325
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
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Mbarara, Uganda
- Mbarara Regional Referral Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Successful delivery of SMS and IVR messages
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Adeline A Boatin, MD MPH, Massachusetts General Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2024P000837
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .