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NCT07621133
Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician.
NCT07543133
This randomized controlled study aims to evaluate the effect of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives. Participants will be randomly assigned to either an intervention group receiving simulation-based training or a control group receiving no additional training. Outcomes will be assessed using validated scales before and after the intervention.
NCT05484804
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 39 prenatal practices across North Carolina. Practices have been 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 \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
NCT07018765
This randomized controlled trial aims to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and perception of traumatic birth among women who have undergone vaginal delivery. The study will be conducted between July and October 2025 at Malatya Training and Research Hospital. Participants in the intervention group will attend an 8-week MBSR program, while the control group will receive no intervention. Data will be collected using validated scales before and after the intervention. The primary outcomes are changes in birth memory and traumatic birth perception scores.
NCT07477106
The investigators want to learn how women's diets may impact breastfeeding outcomes. This study will help the investigators learn more about how diet and social factors like food access may impact mothers' health, breastfeeding, and their baby's health. Participants will attend a visit before birth, then 11 visits as their baby grows up. All visits will be remote using RedCap, phone or video call, text messaging or any other communication modalities of preference to the participant. The investigators will ask for personal information about participants' family, home, and finances, health literacy, medical history, current medications, pregnancy complications, mental health (depression, quality of life), confidence in breastfeeding, eating habits, and plan to feed their baby. After childbirth, the investigators will ask about participants' delivery and child's health, and request access to their child's medical records. Across all visits, the investigators will ask participants to measure their weight, height, blood pressure, activity and sleep, and child's length; the investigators will also ask them to ship urine, stool, and breast milk samples. The investigators will obtain a 24-hour feeding log for the child, as well as a log of what the mother ate and drank over 24 hours.
NCT07200323
Postpartum depression (PPD) is a frequent complication of the postnatal period but remains underdetected in routine clinical practice. This prospective clinical study, conducted at the high-risk pregnancy clinic of the CHUM, aims to estimate the prevalence of PPD among patients seen in postpartum follow-up. It also assesses the feasibility of implementing a standardized screening protocol that combines the administration of the Edinburgh Postnatal Depression Scale (EPDS) with a clinical decision-support algorithm to guide appropriate medical follow-up. The study also seeks to explore clinical characteristics associated with higher EPDS scores.
NCT06349070
The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.
NCT07419568
This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services. The project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking. The study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.
NCT05763537
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
NCT07214012
The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol The hypothesis of this study are 1. The study will achieve feasibility, demonstrated by ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% (e.g., education workbook completion) 2. The intervention will be acceptable, with \>80% of participants reporting satisfaction with Planning Together. 3. Patterns of primary outcomes (contraceptive knowledge, communication quality, community referral utilization) and secondary outcomes (agreed contraceptive plan, consistent contraceptive usage and satisfaction, psychological distress, and Short Interpregnancy Intervals \[SII\]) will suggest benefits of the intervention.
NCT03228875
Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.
NCT07133321
This study aims to improve the health and safety of mothers during pregnancy and childbirth by working closely with their husbands. In many communities in Ethiopia, husbands play an important role in decisions about where women give birth. The study involves educating husbands in group sessions to help them understand how to support their wives during pregnancy, prepare for childbirth, recognize danger signs, and encourage giving birth in health centers where skilled care is available. At the same time, some health workers receive training to improve their ability to handle childbirth emergencies and provide respectful, culturally sensitive care. Communities are divided into groups that receive either husband education, health worker training, both, or no additional support. The study will see which approach helps more women deliver safely in health centers and receive care after birth. By involving husbands and improving health worker skills, this study hopes to support mothers better and improve outcomes for families.
NCT05910580
The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.
NCT05019131
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.
NCT06854705
Background: The Continuity of Midwifery Care (CoMC) is a maternity care model used in some high-income countries. In this model, a dedicated group of midwives supports women throughout pregnancy, labor, and the early postnatal period. This model has been shown to improve maternal and neonatal outcomes and enhance maternal satisfaction. However, its effectiveness in low-and middle-income countries remains uncertain. Purpose and Aim of the Study: This study aims to evaluate whether CoMC, supported by midwife-led birthing centers, improves maternal and neonatal health outcomes compared to the standard care model in Ethiopia. Research Question: Does the CoMC model, integrated with midwife-led birthing centers, enhance maternal and neonatal outcomes compared to the standard maternal health care model? Additionally, does its implementation strengthen midwives' capacity to deliver quality care and increase the uptake of evidence-based practices in Ethiopia? Methods: A hybrid implementation-effectiveness, randomized, controlled, unblinded, parallel-group pilot trial will be conducted. The type 2 hybrid design will equally emphasize effectiveness and implementation outcomes. The study will take place in four randomly selected hospitals in the North Shoa Zone, Amhara regional state, Ethiopia, involving 1,654 pregnant women (\<20 weeks gestation at first ANC visit). Participants will be randomly assigned to CoMC (Group A) or standard care (Group B) using a computer-generated scheme. Midwives will be organized into teams following the CoMC model. Women will receive study information during ANC visits and, if interested, will discuss participation with the CoMC team leader. Upon consent, they will be randomly allocated using a secure computerized system. In the CoMC arm, women will receive care from a single midwife or a backup midwife throughout pregnancy, labor, birth, and the immediate postnatal period. In the standard care arm, multiple staff members will provide care at different times. Outcomes: The primary maternal outcome is the proportion of women achieving spontaneous vaginal birth. The primary neonatal outcome is the proportion of neonates experiencing preterm birth. These outcomes will be analyzed using bivariable and multivariable generalized linear models (GLMs) with 95% confidence intervals.
NCT06680765
Evidence on the effectiveness of interventions aimed at creating demand and access to pre-conceptual and antenatal care (ANC) among adolescent girls and young women (AGYW) from sub-Saharan Africa is scarce. A program called Adolescents 360 (A360) led by Population Services International in Nigeria, Ethiopia, Kenya and Tanzania supports adolescent girls to identify contraceptives as a relevant tool for enabling them to pursue their self-defined life aspirations. Avoiding or delaying childbirth is crucial for AGYW to pursue their life goals, but motherhood remains a vital aspiration for many. A360 respects these aspirations and supports AGYW to pursue motherhood when the time comes, safely and aligning with their unique preferences. In 2022, A360 set out to design a maternal, neonatal and child health (MNCH) component that would be layered to the existing sexual and reproductive health interventions in Ethiopia and Nigeria. A360 employed human-centered design (HCD) to design these components. The implementation of these components in real-world settings began in 2023. A360 has designed an evaluation to determine the effectiveness of the MNCH components in improving the AGYW's comprehensive knowledge of what is needed to pursue healthy pregnancies, increase their self-efficacy to access ANC and garner support from their key influencers in the process of pursuing healthy pregnancies. The evaluation's primary objective is to determine the effectiveness of the MNCH components at increasing comprehensive knowledge, self-efficacy and key influencer support to pursue healthy pregnancies among married AGYW in Nigeria and Ethiopia. The secondary objectives are: (a) to evaluate the component's effectiveness at increasing comprehensive knowledge of what care is required to attain healthy pregnancies, (b) to evaluate the component's effectiveness at increasing self-efficacy to attend ANC, (c) to determine the component's efficacy at eliciting support from AGYW's key influencers when they are pursuing healthy pregnancies, and (d) to surface the system-level barriers, facilitators, and opportunities for program improvement during the implementation of the MNCH components. The MNCH components are implemented in Kaduna and Jigawa states in Nigeria and in Oromia, Sidama, Amhara, South and Central regions in Ethiopia. The evaluation is based in the same geographies where the components are implemented. The evaluation uses an implementation-effectiveness hybrid design, blending an outcome evaluation and an implementation science component. The outcome evaluation constitutes of a quantitative survey using a longitudinal approach with two study arms, an intervention, and a comparison arm. It has three assessments: a recruitment phase, and two follow-ups (3 months after recruitment and 8 weeks post-partum (only for pregnant AGYW). Participant recruitment is conducted using recruitment scripts after obtaining oral consent and the administration of a set of screening questions to assess eligibility. Full consenting procedures are executed and written consent obtained prior to involvement in any of the evaluation components. A structured questionnaire is used to gather quantitative data from the survey using a Computer Assisted Personal Interview (CAPI) approach. Furthermore, FGD, IDI and KII facilitation guides are used to gather qualitative data. During this process, all sessions are audio-recorded. Audio records are transcribed verbatim and translated. Data is collected by trained enumerators and qualitative researchers who are certified to conduct human subjects' research. Analysis of quantitative data will follow a repeated measures approach employing generalized estimating equations. The repeated measurements of each subject will be made at two times. Between group t-tests and chi-square tests of comparison will be conducted to identify secondary outcomes which show statistically significant differences between participants in the intervention and comparison arms. The qualitative data transcripts will be rigorously analyzed using NVivo or Dedoose. Open-coding and closed-coding will be utilized to identify themes in the qualitative data. Claim statements attributing change to key intervention drivers will be drawn from narrative stories of program beneficiaries guided by the intervention's theory of change. The evaluation received ethical approvals from Ethiopian Midwives Association (EMwA) Institutional Review Commitee (IRC) and the PSI Research Ethics Board (REB) prior to the enumerators training and field data collection. Subsequently, the ethical approval letters were submitted to the sub-national health departments for their reference and support in the management of the field work.
NCT06677281
This systematic review aims to evaluate the impact of COVID-19 on pregnancy outcomes. It synthesizes data from various studies to provide insights into the effects of the virus on maternal and fetal health. The review focuses on key outcomes such as preterm birth, maternal complications, and neonatal health, utilizing comprehensive literature from peer-reviewed journals. By analyzing existing studies, we aim to identify trends and gaps in research regarding COVID-19 and pregnancy. This review is intended to inform healthcare providers and pregnant individuals about potential risks and considerations during the pandemic.
NCT05916534
The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care. The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation. Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.
NCT05697822
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.
NCT05716178
Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious organizations.