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Maternal DeathNCT04879797

Reducing Racial Disparities in Severe Maternal Morbidity

A study testing Implementation of Maternal Safety Bundles and Doula Services in people with Maternal Death, run by Tufts University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Death
What is being tested?
Implementation of Maternal Safety Bundles and Doula Services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,538 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures • Inclusion criteria: Births at the five participating hospital sites for Intervention 1, collecting data one year prior to, during and one year after the study period.

PREM PROM (Patient Reported Experience Measure ( PREM) Patient Reported Outcome Measure (PROM) Surveys for Intervention I

  • Inclusion criteria for Pre- and post- surveys for Maternal Safety Bundles Implementation: Birthing individuals who have delivered six weeks to one year prior to the interview at the five participating sites in Intervention 1

Focus groups for Intervention I

  • Inclusion criteria: Obstetrical care providers including nurses, midwives, family practitioners, attending obstetricians and trainee obstetricians employed at the five participating hospital sites will be invited to participate in focus groups.

Intervention II (Community doula support) Severe Maternal Mortality (SMM) 21 Outcome Measures • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program. The study will include in the intervention arm 340 pregnant women who (1) live in the state of MA, (2) identify as Black or African American, (3) are offered doula care by either their provider or their payer-based navigation program and (4) deliver at one of the four delivering hospitals (Beth Israel Lahey, Boston Medical Center, St. Elizabeth's Medical Center, and Baystate Medical Center). Concurrently, the 340 birthing individuals who were offered doula care in the intervention arm will be matched with birthing individuals who identify as Black or African American, have a live birth, and deliver at one of four hospitals and have similar demographics such as age, comorbidities, payer status, etc.

Focus groups for Intervention II • Inclusion criteria: Persons who practice or identify as community doulas and work with clients who deliver in the state of Massachusetts and have assisted a client in pregnancy, birth, or postpartum within the past 12 months prior to the focus group discussion; obstetrical care provider including nurses, midwives, family medicine practitioners, attending obstetricians, and obstetricians employed at the four participating hospital sites as well as community doula programmatic staff who are employed at participating hospitals sites, or participating community doula organizations, or payers

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

  • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program.

Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures

  • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I

  • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention I

  • Exclusion criteria: Staff who have contact with patients but do not identify in the provider types listed in the inclusion criteria

Intervention II (Community doula support) SMM 21 Outcome Measures • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention II • Exclusion criteria: Staff who have contact with clients but do not identify in the provider types listed in the inclusion criteria

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

  • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the four participating hospitals

Trial locations and contacts

1 site in 1 country.

Ndidiamaka Amutah Onukagha, PhD contact

(617) 636-3809

ndidiamaka.amutah_onukagha@tufts.edu

Judith Jeanty, MPH contact

judith.jeanty@tufts.edu

United States1 site, 1 recruiting

  • Tufts University

    Boston, Massachusetts, 02128

    Judith Jeanty, 617-636-3847, judith.jeanty@tufts.edu

    Recruiting

Other trials in United States

About this study

Official title: Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women

There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. The proposed mixed-methods study is the first systematic investigation of pregnancy complications and outcomes among Black women with whom maternal safety bundles are being implemented including racial disparities, hemorrhage, and hypertension. Additionally, through the analysis of secondary state level data, this study will examine perinatal care, maternal outcomes, and healthcare utilization of Black women at increased risk of severe maternal morbidity and mortality compared with non-Latino white women. Finally, through individual interviews with Black women and focus groups with obstetric health providers and doulas, the study will examine disparities and improve care by creating and disseminating a set of practice recommendations for maternity care for Black women at increased risk of morbidity and mortality.

Research has not yet examined the intersection of race/ethnicity, doulas, and quality improvement (QI) interventions, such as maternal safety bundles, on reducing SMM and mortality among non-Hispanic Black (NHB) women. The overall goal of this mixed-methods study is to use analysis of existing big data and the evaluation of two interventions to ultimately develop targeted recommendations for addressing these inequities. Our approach leverages multiple data sources to study maternal outcomes and access to care during the prenatal, birth, and postpartum periods in order to identify commonalities among women who experienced SMM and use those findings to create a risk profile of women who are more likely to experience SMM; examine the implementation of maternal safety bundles on SMM and MM outcomes for women up to 1 year postpartum (Intervention 1); gather in-depth data from obstetric care providers on factors that support or hinder safety bundle implementation (Intervention 1); and gather in-depth data from individual women and doulas on facilitators of barriers to the use of doulas to improve care and address inequities (Intervention 2).

Read the detailed description

Background / Literature Review / Rationale for the study:

Black women experience stark disparities in pregnancy complications and outcomes compared to White women. Recognizing, tracking and understanding patterns of severe maternal morbidity (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of providers in the planning and implementation of maternal safety bundles or engaging mothers in prenatal, birth and postpartum support from community doulas. The investigators will use the Health Impact Pyramid and CFIR Framework (Consolidated Framework for Implementation) to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, the investigators intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with Black women, and focus groups with obstetrical care providers and doulas to explore the effect of implementing safety bundles and incorporating doula-provided services into prenatal, birth and postpartum care.

Conditions
Maternal Death
Being tested
Implementation of Maternal Safety Bundles, Doula Services
Medical subject headings
Maternal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of Maternal Safety BundlesOther

    In the second phase, implementation of the bundles will take place. During this phase investigators will conduct quarterly surveys with the health facilities to measure implementation progress, including an index of evidence-based practices. Investigators will conduct surveys with postpartum women to measure their patient experience. Surveys will be conducted using RedCap software. Participants will be given the opportunity to complete the survey online or if they prefer, a research assistant can call them to conduct the survey over the phone. Data on SMM will be collected through PELL

  • Doula ServicesOther

    Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.

Study groups in NCT04879797
Study groupRoleWhat they receive
Maternal Safety Bundles ImplementationOtherThe first intervention targets obstetric hemorrhage, severe hypertension and maternal health equity by implementing three relevant AIM bundles: Obstetric Hemorrhage, Severe Hypertension in Pregnancy, and Reduction of Peripartum Racial/Ethnic Disparities. The Perinatal Neonatal Quality Improvement Network (PNQIN) will facilitate this collaborative QI project and support participating hospitals by providing guidance, education, and technical assistance to hospitals to support implementation of bundles using the QI process. Implementation strategies are based on the Institute for Healthcare Improvement (IHI) improvement model and the AIM program implementation toolkit and have previously been used by PNQIN to implement the Obstetric Care for Women with Opioid Use Disorder AIM bundle in 22 hospitals, including the five hospitals for this study.
Receives: Other: Implementation of Maternal Safety Bundles
Doula ServicesOtherThe second intervention that this study evaluates is doula services. Investigators are evaluating doula services that are offered by two doula organizations at three hospitals. Investigators will provide top-up training to these doulas in order to provide some standardization and quality assurance of the services delivered. The training is developed and delivered by an obstetrician (Meadows) and doula (Gebel) and will take place among providers (staff associated with three chosen hospitals), patient navigators, and two doula groups, Birth Sisters and Accompany Doula Care, on factors that comprise the risk profile and how to offer targeted doula services to women who fit the risk profile. All sites will use standardized data instruments to evaluate the number of factors in the risk profile being met as well as standardized language and recruitment materials for mothers.
Receives: Other: Doula Services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient experience - Respect

    Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.

    Measured: 6 -12 weeks postpartum

  2. Patient experience - Autonomy

    Mothers autonomy in decision making (MADM). The range is 7- 42 with higher score indicating more opportunities to take an active role and lead decisions.

    Measured: 6 -12 weeks postpartum

  3. Severe maternal morbidity (SMM) 20

    Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 20 ICD 10 codes as defined by the CDC.

    Measured: At delivery

  4. Cesarean Birth

    The proportion of women with live births who have a C-section.

    Measured: At delivery

  5. Severe maternal morbidity (SMM) 21

    Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 21 ICD 10 codes as defined by the CDC.

    Measured: At delivery

Secondary outcomes (22)

  1. Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate

    Of all NTSV births the proportion that result in C-section

    Measured: At delivery

  2. Severe Maternal Morbidity among Hemorrhage Cases

    Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, meeting one of the following criteria:

    • Presence of an Abruption, Previa or Antepartum hemorrhage diagnosis code
    • Presence of transfusion procedure code without a sickle cell crisis diagnosis code
    • Presence of a Postpartum hemorrhage diagnosis code Numerator: Among the denominator, all cases with any SMM code

    Measured: Monthly up to 6 months

  3. Severe Maternal Morbidity (excluding cases with only a transfusion code) among Hemorrhage Cases.

    Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, meeting one of the following criteria:

    • Presence of an Abruption, Previa or Antepartum hemorrhage diagnosis code
    • Presence of transfusion procedure code without a sickle cell crisis diagnosis code
    • Presence of a Postpartum hemorrhage diagnosis code Numerator: Among the denominator, all cases with any non-transfusion SMM code

    Measured: Monthly up to 6 months

  4. Process Measure for Obstetric Hemorrhage - Unit Drills

    Report number of Drills and the drill topics P1a: In this quarter, how many OB drills (In Situ and/or Sim Lab) were performed on your unit for any maternal safety topic? P1b: In this quarter, what topics were covered in the OB drills?

    Measured: Monthly up to 6 months

  5. Process Measure for Obstetric Hemorrhage - Provider Education

    Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of delivering physicians and midwives has completed within the last 2 years an education program on Obstetric Hemorrhage that includes the unit-standard protocols and measures?

    Measured: Monthly up to 6 months

  6. Process Measure for Obstetric Hemorrhage - Nursing Education

    Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of OB nurses (including L\&D and Postpartum) has completed within the last 2 years an education program on Obstetric Hemorrhage that includes the unit-standard protocols and measures?

    Measured: Monthly up to 6 months

  7. Process Measure for Obstetric Hemorrhage - Risk Assessment

    Report estimate in 10 percent increments (round up) At the end of this quarter, what cumulative proportion of mothers had a hemorrhage risk assessment with risk level assigned, performed at least once between admission and birth and shared among the team?

    Measured: Monthly up to 6 months

  8. Process Measure for Obstetric Hemorrhage - Quantified Blood Loss Measurement Utilization

    Report estimate in 10 percent increments (round up) In this quarter, what proportion of mothers had measurement of blood loss from birth through the recovery period using quantitative and cumulative techniques?

    Measured: Monthly up to 6 months

  9. Structure Measure for Obstetric Hemorrhage - Patient, Family & Staff Support System

    Report Completion Date Has your hospital developed OB specific resources and protocols to support patients, family and staff through major OB complications?

    Measured: Monthly up to 6 months

  10. Structure Measure for Obstetric Hemorrhage - Debriefs System

    Report Start Date Has your hospital established a system in your hospital to perform regular formal debriefs after cases with major complications?

    Measured: Monthly up to 6 months

  11. Structure Measure for Obstetric Hemorrhage - Multidisciplinary Case Reviews

    Report Start Date Has your hospital established a process to perform multidisciplinary systems-level reviews on cases of severe maternal morbidity (including, at a minimum, birthing patients admitted to the ICU or receiving ≥ 4 units RBC transfusions?

    Measured: Monthly up to 6 months

  12. Structure Measure for Obstetric Hemorrhage - Hemorrhage Cart

    Report Completion Date Does your hospital have OB hemorrhage supplies readily available, typically in a cart or mobile box?

    Measured: Monthly up to 6 months

  13. Structure Measure for Obstetric Hemorrhage - Unit Policy and Procedure

    Report Completion Date Does your hospital have an OB hemorrhage policy and procedure (reviewed and updated in the last 2-3 years) that provides a unit-standard approach using a stage-based management plan with checklists?

    Measured: Monthly up to 6 months

  14. Structure Measure for Obstetric Hemorrhage - EHR Integration

    Report Completion Date Were some of the recommended OB Hemorrhage bundle processes (i.e. order sets, tracking tools) integrated into your hospital's Electronic Health Record system?

    Measured: Monthly up to 6 months

  15. Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases

    Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, with one of the following diagnosis codes:

    • Severe Preeclampsia
    • Eclampsia
    • Preeclampsia superimposed on pre-existing hypertension Numerator: Among the denominator, all cases with any non-transfusion SMM code

    Measured: Monthly up to 6 months

  16. Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases

    Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, with one of the following diagnosis codes:

    • Severe Preeclampsia
    • Eclampsia
    • Preeclampsia superimposed on pre-existing hypertension Numerator: Among the denominator, all cases with any non-transfusion SMM code

    Measured: Monthly up to 6 months

  17. Process Measure for Severe Hypertension/Preeclampsia - Treatment of Severe HTN

    Report N/D Denominator: Birthing patients with acute-onset severe hypertension that persists for 15 minutes or more, including those with preeclampsia, gestational or chronic hypertension Numerator: Among the denominator, birthing patients who were treated within 1 hour with IV Labetalol, IV Hydralazine, or PO Nifedipine. The 1 hour is measured from the first severe range BP reading, assuming confirmation of persistent elevation through a second reading.

    Measured: Monthly up to 6 months

  18. SMM 20 by Race and Ethnicity

    Severe maternal morbidity (SMM) by Race and Ethnicity includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 20 ICD 10 codes as defined by the CDC.

    Measured: Monthly up to 2 years

  19. SMM 21 by Race and Ethnicity

    Severe maternal morbidity (SMM) by Race and Ethnicity includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 21 ICD 10 codes as defined by the CDC.

    Measured: Monthly up to 2 years

  20. Process Measure for Severe Hypertension/Preeclampsia - Unit Drills

    Report number of Drills and the drill topics P1a: In this quarter, how many OB drills (In Situ and/or Sim Lab) were performed on your unit for any maternal safety topic? P1b: In this quarter, what topics were covered in the OB drills?

    Measured: Monthly up to 6 months

  21. Process Measure for Severe Hypertension/Preeclampsia - Provider Education

    Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of delivering physicians and midwives has completed within the last two years an education program on Severe Hypertension/Preeclampsia that includes the unit-standard protocols and measures?

    Measured: Monthly up to 6 months

  22. Process Measure for Severe Hypertension/Preeclampsia - Nursing Education

    Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of OB nurses (including L\&D and postpartum) has completed within the last two years an education program on Severe Hypertension/Preeclampsia that includes the unit-standard protocols and measures?

    Measured: Monthly up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2021
  2. Study start1 Oct 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Hybrid type 1 implementation
Masking
None (open label)
Enrolment
1,538 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04879797
Sponsor's protocol ID
M530001 NIH172
Other IDs
1R01MD016026-01
Status last verified
Sep 2023
First submitted
17 Mar 2021
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fernandes KG, Sousa MH, Cecatti JG. Skin Color and Maternal Near Miss: Exploring a Demographic and Health Survey in Brazil. Rev Bras Ginecol Obstet. 2017 May;39(5):209-216. doi: 10.1055/s-0037-1603498. Epub 2017 May 22.

    PubMed 28561138

  • Thomas MP, Ammann G, Brazier E, Noyes P, Maybank A. Doula Services Within a Healthy Start Program: Increasing Access for an Underserved Population. Matern Child Health J. 2017 Dec;21(Suppl 1):59-64. doi: 10.1007/s10995-017-2402-0.

    PubMed 29198051

  • Burns JJ, Livingston R, Amin R. The Proximity of Spatial Clusters of Low Birth Weight and Risk Factors: Defining a Neighborhood for Focused Interventions. Matern Child Health J. 2020 Aug;24(8):1065-1072. doi: 10.1007/s10995-020-02946-y.

    PubMed 32350727

  • Elkafrawi D, Sisti G, Araji S, Khoury A, Miller J, Rodriguez Echevarria B. Risk Factors for Neonatal/Maternal Morbidity and Mortality in African American Women with Placental Abruption. Medicina (Kaunas). 2020 Apr 13;56(4):174. doi: 10.3390/medicina56040174.

    PubMed 32295061

  • Ferranti EP, Frediani JK, Mitchell R, Fernandes J, Li S, Jones DP, Corwin E, Dunlop AL. Early Pregnancy Serum Metabolite Profiles Associated with Hypertensive Disorders of Pregnancy in African American Women: A Pilot Study. J Pregnancy. 2020 Feb 19;2020:1515321. doi: 10.1155/2020/1515321. eCollection 2020.

    PubMed 32148965

  • Gyamfi-Bannerman C, Srinivas SK, Wright JD, Goffman D, Siddiq Z, D'Alton ME, Friedman AM. Postpartum hemorrhage outcomes and race. Am J Obstet Gynecol. 2018 Aug;219(2):185.e1-185.e10. doi: 10.1016/j.ajog.2018.04.052. Epub 2018 May 9.

    PubMed 29752934

  • Wallace ME, Crear-Perry J, Green C, Felker-Kantor E, Theall K. Privilege and deprivation in Detroit: infant mortality and the Index of Concentration at the Extremes. Int J Epidemiol. 2019 Feb 1;48(1):207-216. doi: 10.1093/ije/dyy149.

    PubMed 30052993

  • Ratnasiri AWG, Parry SS, Arief VN, DeLacy IH, Lakshminrusimha S, Halliday LA, DiLibero RJ, Basford KE. Temporal trends, patterns, and predictors of preterm birth in California from 2007 to 2016, based on the obstetric estimate of gestational age. Matern Health Neonatol Perinatol. 2018 Dec 12;4:25. doi: 10.1186/s40748-018-0094-0. eCollection 2018.

    PubMed 30564431

  • Howell EA, Egorova NN, Balbierz A, Zeitlin J, Hebert PL. Site of delivery contribution to black-white severe maternal morbidity disparity. Am J Obstet Gynecol. 2016 Aug;215(2):143-52. doi: 10.1016/j.ajog.2016.05.007. Epub 2016 May 12.

    PubMed 27179441

  • Gillespie SL, Christian LM, Alston AD, Salsberry PJ. Childhood stress and birth timing among African American women: Cortisol as biological mediator. Psychoneuroendocrinology. 2017 Oct;84:32-41. doi: 10.1016/j.psyneuen.2017.06.009. Epub 2017 Jun 15.

    PubMed 28651102

  • Small MJ, James AH, Kershaw T, Thames B, Gunatilake R, Brown H. Near-miss maternal mortality: cardiac dysfunction as the principal cause of obstetric intensive care unit admissions. Obstet Gynecol. 2012 Feb;119(2 Pt 1):250-5. doi: 10.1097/AOG.0b013e31824265c7.

    PubMed 22270275

  • Hans SL, Edwards RC, Zhang Y. Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):105-113. doi: 10.1007/s10995-018-2537-7.

    PubMed 29855838

  • Poon LC, Kametas NA, Chelemen T, Leal A, Nicolaides KH. Maternal risk factors for hypertensive disorders in pregnancy: a multivariate approach. J Hum Hypertens. 2010 Feb;24(2):104-10. doi: 10.1038/jhh.2009.45. Epub 2009 Jun 11.

    PubMed 19516271

  • Mehta PK, Kieltyka L, Bachhuber MA, Smiles D, Wallace M, Zapata A, Gee RE. Racial Inequities in Preventable Pregnancy-Related Deaths in Louisiana, 2011-2016. Obstet Gynecol. 2020 Feb;135(2):276-283. doi: 10.1097/AOG.0000000000003591.

    PubMed 31923055

  • Bernet P, Gumus G, Vishwasrao S. Maternal Mortality and Public Health Programs: Evidence from Florida. Milbank Q. 2020 Mar;98(1):150-171. doi: 10.1111/1468-0009.12442. Epub 2020 Jan 14.

    PubMed 31943403

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of Maternal Safety Bundles and Doula Services in people with Maternal Death, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ndidiamaka Amutah Onukagha, PhD ((617) 636-3809, ndidiamaka.amutah_onukagha@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient experience - Respect (time frame: 6 -12 weeks postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04879797, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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