Maternal Health Clinical Trial
— CITHOfficial title:
The Effect of a Patient-involved Mobile Phone and Cloud-based Electronic Contact and Recording System on Institutional Deliveries and Other Maternal and Infant Health Outcomes in Rural Nepal: A Cluster Randomized Controlled Trial
The goal of this cluster randomized controlled trial is to study the effect of a mobile-phone based application used by pregnant women on maternal and newborn health indicators. The main objective is to compare the rates of institutional deliveries in the intervention and control arms. Ancillary objectives are to compare the birth-preparedness and complication readiness parameters, severe maternal morbidity rates and neonatal adverse outcomes rates in the two arms. The participants are pregnant women. In the intervention arm pregnant women will be given a smart mobile phone with an application that they will use to input information related to their health. This information can be shared with their healthcare workers. The healthcare workers will also be able to access all the health-related details of the pregnant women and mothers under their care by accessing this app in their mobile phones and be in touch with their patients through the mobile phone application. The control arm will adhere to existing practices of pregnant woman and health worker communication without the use of a smart mobile phone with an existing application. Records related to the pregnant woman will be kept in paper-based forms as is the usual norm. The investigators will compare the intervention arm and the control arm to see if there are differences in the rates of the outcomes.
Status | Not yet recruiting |
Enrollment | 360 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Pregnant with less than 20 weeks of gestation - Usual resident of the study ward at the time of enrollment (A woman is considered a usual resident if the house she normally lives is in, is in that ward) - Provides informed written consent Exclusion Criteria: - Temporary resident of the ward - Cannot read and write - Cannot use a mobile phone - Has any disability, such as blindness, that prevents the use of mobile phone |
Country | Name | City | State |
---|---|---|---|
Nepal | Patan Academy of Health Sciences | Lalitpur | Bagmati |
Lead Sponsor | Collaborator |
---|---|
Amit Arjyal | Bagmati Rural Municipality, Lalitpur, Nepal, Konjyosom Rural Municipality, Lalitpur, Nepal, Mahankal Rural Municipality, Lalitpur, Nepal, School of Health Sciences, Purbanchal University, Nepal |
Nepal,
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Nam JY. Comparison of global indicators for severe maternal morbidity among South Korean women who delivered from 2003 to 2018: a population-based retrospective cohort study. Reprod Health. 2022 Aug 13;19(1):177. doi: 10.1186/s12978-022-01482-y. — View Citation
Neupane B, Rijal S, Gc S, Basnet TB. A Multilevel Analysis to Determine the Factors Associated with Institutional Delivery in Nepal: Further Analysis of Nepal Demographic and Health Survey 2016. Health Serv Insights. 2021 Jun 14;14:11786329211024810. doi: 10.1177/11786329211024810. eCollection 2021. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Institutional Delivery Rate | Delivery at a birthing center, health post, primary health care center, or any hospital | At the time of delivery | |
Secondary | Birth Preparedness and Complication Readiness Index Score | Birth preparedness and complication readiness index score will be used. It is based on JHPIEGO manual on monitoring birth preparedness and complication readiness- tools and indicators for maternal and newborn health. This is based on a set of indicators for monitoring safe motherhood. The final score is the average of thirteen(13) items in three(3) domains, namely, knowledge of key danger signs around pregnancy, service use and planning actions- both intention and behavior, and knowledge of community resources. A score will be calculated for each item as a percentage of the respondents who meet the item criteria. The final score is the mean of the scores in each of the 13 items. The score can range from 0% to 100%, higher score indicating better birth preparedness and complication readiness. The scores will be compared between the intervention and control arms. | Upto 42 days after delivery | |
Secondary | Severe Maternal Morbidity (SMM) Rate | Severe Maternal Morbidity criteria will be as defined by the American College of Obstetricians and Gynecologists (ACOG) criteria:
The occurrence of at least one of 21 SMM indicators: Acute Myocardial Infarction, Aneurysm, Acute renal failure, Adult respiratory distress syndrome, Amniotic fluid embolism, Cardiac arrest/ ventricular fibrillation, Conversion of cardiac rhythm, Disseminated Intravascular coagulation, Eclampsia, Heart Failure/Arrest during surgery or procedure, Puerperal cerebrovascular disorders, Pulmonary edema/ Acute heart failure, Severe anesthesia complication, Sepsis, Shock, Sickle cell disease with crisis, Air and thrombotic embolism, Blood product transfusion, Hysterectomy, Temporary tracheostomy and Ventilation. Intensive care unit (ICU) admission Prolonged length of postnatal hospital stay (> 48 hours and >96 hours for vaginal delivery and cesarean section respectively) Transfusion of >/= 4 units of packed blood cells Hospital readmission |
Upto 42 days after delivery | |
Secondary | Neonatal Adverse Outcome (NAO) Rate | NAO will be defined as the occurrence of at least one of 28 diagnostic and procedure components:
Diagnosis: Gestational age < 32 weeks, birthweight <1500 grams, death within 28 days of birth, Birth trauma, Cerebral conditions like: Intraventricular haemorrhage, Hypoxic-ischemic encephalopathy, seizures, or other cerebral diagnosis, Respiratory conditions like: Pneumonia, Respiratory distress syndrome, Bronchopulmonary dysplasia and Other respiratory diagnosis, Sepsis/septicaemia, Necrotising enterocolitis Procedure: Resuscitation or intubation recorded on birth record, Transferred to higher center within 24 hours, 2-999 hours of mechanical ventilation, Invasive ventilation procedure, Non-invasive ventilation procedure, Resuscitation procedure, Arterial/central catheter procedure, Transfusion of blood or blood products, Intravenous fluid procedure, Surgical procedures: Abdominal, cardiac, thoracic and urinary system |
Upto 42 days after delivery | |
Secondary | Newborn Mortality Indicators | Number of still births, early and late neonatal mortality, or infant mortality | Upto 42 days after delivery | |
Secondary | Maternal Mortality Indicator | Number of maternal deaths | Upto 42 days after delivery |
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