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Maternal Safety Interventions for Reducing Severe Maternal Morbidity
N/A
Recruiting
Led By Ndidiamaka Amutah Onukagha, PhD
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly up to 6 months
Awards & highlights
Study Summary
This trial will use a mixed-methods design to study the implementation of maternal safety bundles and doulas to reduce severe maternal morbidity and mortality among black women.
Who is the study for?
This trial is for Black or African American women in Massachusetts who are pregnant and will deliver at one of the four participating hospitals. It includes community doulas, obstetric care providers, and hospital staff involved with these patients. Excluded are pregnancies ending before 20 weeks or due to ectopic pregnancy not on labor units.Check my eligibility
What is being tested?
The study tests how implementing maternal safety bundles and providing doula services affect severe maternal morbidity (SMM) and mortality among Black women. It uses surveys, data analysis, and interviews with healthcare providers and doulas to develop targeted care recommendations.See study design
What are the potential side effects?
Since this trial involves service implementation rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect impacts on patient experience based on changes in care practices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cesarean Birth
Patient experience - Autonomy
Patient experience - Respect
+2 moreSecondary outcome measures
Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate
Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases
Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases
+19 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Maternal Safety Bundles ImplementationExperimental Treatment1 Intervention
The 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.
Group II: Doula ServicesExperimental Treatment1 Intervention
The 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.
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Who is running the clinical trial?
Tufts UniversityLead Sponsor
265 Previous Clinical Trials
660,365 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,214,821 Total Patients Enrolled
1 Trials studying Maternal Death
320 Patients Enrolled for Maternal Death
Baystate Medical CenterOTHER
63 Previous Clinical Trials
42,735 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pregnancy ended before 20 weeks not due to an ectopic pregnancy in the specified hospitals.My pregnancy ended before 20 weeks not due to an ectopic pregnancy in the specified hospitals.
Research Study Groups:
This trial has the following groups:- Group 1: Maternal Safety Bundles Implementation
- Group 2: Doula Services
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective of this experiment?
"Over the course of 6-12 weeks postpartum, this clinical trial will assess patient experience and respect. Secondary goals include tracking severe hypertension/preeclampsia education completions among nurses in 10% increments, as well as measuring non-transfusion related severe maternal morbidity cases (excluding those with only transfusion codes) caused by hemorrhage; additionally, obstetric hemorrhage educational completion rates must also be tracked for OB nurses within these two years."
Answered by AI
Are there any current openings for participants in this trial?
"Correct. According to clinicaltrials.gov, this trial is actively recruiting participants as of May 10th 2022 - the date it was last updated from its initial posting on October 1st 2021. 1538 individuals are required for enrolment at a single medical centre."
Answered by AI
How many participants are being monitored for this medical experiment?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical study, originally posted on October 1st 2021, is actively recruiting volunteers. 1538 participants must be enrolled from a single medical centre."
Answered by AI
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