Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Perceptions of Provider Communication
Study Overview
Brief Summary
The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Black birthing people
- •Received care and plan to delivery at the University of Kansas Medical Center
- •Scored positive to social determinants of health screener
- •Gestational age between 14-27.6 weeks at enrollment
Exclusion Criteria
- •Pregnancy not viable or pregnancy not intrauterine on ultrasound
- •Patients who are not willing to be randomized into not receiving doula enhanced
- •Patients who do not plan to delivery at the University of Kansas Health System
- •Non-Black birthing people.
- •Planned cesarean section
- •Patients with a known major fetal anomaly
- •Non-English speaking
Arms & Interventions
Doula-Enhanced Care Group
This group received doula-enhanced care along with routine pregnancy care.
Intervention: Doula Care (Behavioral)
Routine Pregnancy Care Group
This group received routine pregnancy care.
Outcomes
Primary Outcomes
Perceptions of Provider Communication
Time Frame: Study enrollment through 6-weeks postpartum
Assess patient's perception of their quality of communication with their provider using a Likert scale survey (ie. did the patient feel comfortable asking their prenatal provider questions regarding their health, did the patient feel listened to by their provider. Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediate postdelivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.
Perceptions of Maternal Care
Time Frame: Study enrollment through 6-weeks postpartum
Assess patient's perceptions of maternal care using a Likert scale survey (i.e. their physician spending time with the patient talking to them about their labor and delivery expectations) Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediately post-delivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.
Secondary Outcomes
- Neonatal Morbidity(Birth through 6-weeks postpartum)
- Perinatal Outcome - Gestational Age (GA) at Delivery(14-28 weeks GA through delivery)
- Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births(14-28 weeks GA through delivery)
- Perinatal Outcome - Number of Participants With Cesarean Sections(14-28 weeks GA through delivery)
- Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia(14-28 weeks GA through delivery)
- Neonatal Morbidity(Birth/delivery)
- Antepartum Depression(Study enrollment through delivery)
- Postpartum Depression(Birth (delivery) through 6-weeks postpartum)
- Maternal Pain Management(Delivery through hospital discharge)
- Lactation Status - Number of Participants Lactating and Breastfeeding(Birth)
- Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge(Birth through 6-weeks postpartum)