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Maternal Death clinical trials

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NCT ID: NCT06273007 Recruiting - Stillbirth Clinical Trials

Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach

PartoMa-Eth
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Overall Objective To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia. Interventions 1. Locally agreed and achievable intrapartum guidelines 2. Low dose high frequency trainings (LDHF) 3. Partograph Overall Design A quasi-experimental pre-post study (PartoMa study) Setting Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia. Population Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge. Endpoints The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below. Study Time Data collection from June 2023 to May 2025. Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital. iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital. iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital. Setting PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.

NCT ID: NCT06268509 Recruiting - Preterm Birth Clinical Trials

Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta

MONAS
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services? 2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services? Participants in the intervention group will receive: - Fetomaternal ultrasound examination each trimester - Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination - Supplements: multivitamin, minerals, vitamin D, fatty acid - Intervention regarding any abnormal results of nutritional panel - All standard maternal health services according to Indonesian Ministry of Health protocol Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol

NCT ID: NCT06134518 Not yet recruiting - Maternal Mortality Clinical Trials

Effectiveness of the Education Program on Increasing the Competency Level of Health Cadres in Indonesia

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

Ending preventable maternal mortality (EPMM): By 2030, every country should reduce its maternal mortality ratio (MMR) by at least two-thirds from the 2010 baseline. In the era of the SDGs, an acceleration of current progress is required to achieve SGD target 3.1, working towards a vision of ending all preventable maternal mortality. In Central Java, one of the most effective efforts to reduce maternal mortality is increasing the number of human resources, who can assist pregnant mothers and supervise their period of pregnancy. The maternal mortality rate (MMR) in Banjarnegara Regency in 2021 is 287.05 per 100,000 live births, this indicates the top 10 in Central Java Province over the past 5 years. Health cadres, who are non-professional volunteer health supporters for pregnant women appointed by regional public health centers (PHCs), are expected to be the key human resources who contribute to reducing MMR in Indonesia and Banjarnegara Regency as well. However, based on an initial study by researchers conducting qualitative research with focus group discussions (FGDs) and in-depth interviews in April-July 2023, researchers found that health cadres had incorrect and unscientific knowledge. Therefore, improving the knowledge and skills of the health cadres through education programs could be expected to further improve the health outcomes of pregnant women, consequently contributing to reducing the MMR. The purpose of this study is to improve health cadres' competency level in monitoring the risks of pregnant women. This monitoring activities for pregnant women by cadres is an effort to prevent maternal mortality, because if there are complications they can be treated as early as possible.

NCT ID: NCT05865873 Recruiting - Maternal Death Clinical Trials

Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Region, Ethiopia

MHSU
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Introduction: Maternal health service (MHS) utilization helps to decrease maternal morbidity and mortality. However, the existing evidence is not sufficient to design effective and efficient strategies. Objective: This study aims to improve maternal health service utilization among women of reproductive age in the Dale and Wonsho districts of the Sidama region, Ethiopia. Methods: A community-based cross-sectional study will be carried out to assess the utilization and predictors of maternal health care. A phenomenological qualitative study will be conducted to explore perceptions, barriers, and facilitators of maternal health care. A cluster randomized controlled trial will be employed to assess the effect of health education on maternal knowledge about obstetric danger signs, birth preparedness and complication readiness plan, and maternal health service utilization (MHSU). The minimum required sample size is 1,104 for a cross-sectional study. To explore perceptions, barriers, and facilitators of maternal health care a minimum of 20 in-depth interviews, 3 focus group discussions per group, and 20 key informative interviews will be conducted. The minimum required sample size to assess the effect of health education on outcomes is 942. Data will be entered into Epi Data version 3.1 and exported to the SPSS and Stata software for analysis. Descriptive analyses will be carried out to get descriptive measures for the important variables of interest. The generalized estimated equations analysis will be used to assess the potential predictors of MHSU. The coding and analysis of the qualitative data will be done using the thematic content analysis technique by Atlas-Ti software and presented in narratives. Schedule and budget: This study will be conducted from October to August 2023; the total cost of the project will be 421,600 ETB (7,026.67 EURO).

NCT ID: NCT05678699 Recruiting - Maternal Death Clinical Trials

The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to learn about the effects of structural inventions, such as equity-focused Medicaid polices, on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are: 1. What is the effect of Medicaid healthcare quality interventions on SMM? 2. What is the effect of Medicaid healthcare quality interventions + doula care? 3. What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services and equity practices? Participants will be asked to describe experiences as a result of structural interventions and focused Medicaid policies.

NCT ID: NCT05640050 Enrolling by invitation - Stillbirth Clinical Trials

Integrated Community Engagement and Audit Systems

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The goal of this implementation research project is to determine the feasibility of establishing and implementing an acceptable and robust audit system with community representation at secondary health facilities to improve maternal and perinatal outcomes. The implementation phases follow the standard World Health Organization (WHO) audit system. The initial step includes identifying death cases for review and subsequently collecting the detailed information on the near miss and adverse event history. A mixed methods data analysis will include both quantitative components, such as identification of trends in rates and causes of death and geographic location, and qualitative components, such as analysis of modifiable factors. The use of both types of data will provide a robust analysis of the problems and aid the audit team iin identifying and supporting priorities for action. The three-delay's model categorize the modifiable factors as the first delay (recognition of danger sign and care-seeking decision), second delay (identification and reaching health facility) and third delays (receiving adequate care and treatment at facilities). The audit team will make recommendations in collaboration with community representatives. The findings of the audits will be shared with the health facility authorities, program managers and community representatives to support policy and practice changes. A monthly monitoring cycle will be set up within the implementing facilities to ensure effective implementation of the audit systems.

NCT ID: NCT05484804 Recruiting - Pregnancy Related Clinical Trials

Accountability for Care Through Undoing Racism & Equity for Moms

ACURE4Moms
Start date: June 5, 2023
Phase: N/A
Study type: Interventional

This project-also known as "Accountability for Care through Undoing Racism & Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 40 prenatal practices across North Carolina. Practices will be randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for ~750 patients (30,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.

NCT ID: NCT05430815 Active, not recruiting - Maternal Death Clinical Trials

Improving Women's Health Through Coordinated Postpartum Planning

Start date: August 8, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.

NCT ID: NCT05382403 Recruiting - Clinical trials for Postpartum Hemorrhage

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

NOVIC
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.

NCT ID: NCT05339867 Recruiting - Post-Partum Clinical Trials

Prevent Maternal Mortality Using Mobile Technology

Start date: March 22, 2022
Phase: N/A
Study type: Interventional

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.