Black Maternal and Infant Health, Doula Care, Pregnancy Related, Prenatal Care
Conditions
Brief summary
The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.
Interventions
BEHAVIORALDoula Care
Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
Sponsors
University of Kansas Medical Center
BioNexus KC
Blue KC (Blue Cross Blue Shield)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceptions of Provider Communication | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Perinatal Outcome - Gestational Age (GA) at Delivery | 14-28 weeks GA through delivery | Assess gestational age (GA) at delivery by collecting data from their patient surveys and chart. GA at delivery (write number with one decimal place - "weeks.days". For example, 23 weeks and 4 days = 23.4) |
| Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births | 14-28 weeks GA through delivery | Assess preterm \<37 weeks births by collecting data from their patient surveys and chart. |
| Perinatal Outcome - Number of Participants With Cesarean Sections | 14-28 weeks GA through delivery | Assess cesarean sections by collecting data from their patient surveys and chart. |
| Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia | 14-28 weeks GA through delivery | Assess gestational hypertension/preeclampsia diagnosis by collecting data from their patient surveys and chart. |
| Neonatal Morbidity | Birth/delivery | Assess neonatal morbidity by collecting neonatal 5-min Appearance, Pulse, Grimace, Activity, Respiration (APAGAR) score \<7. Each of the five criteria can be scored 0-2 with a possible total test score ranging from 0-10 with three subcategories; reassuring: score 7-10, moderately abnormal: 4-6 and low: 0-3. A higher score indicates better neonatal outcomes. |
| Antepartum Depression | Study enrollment through delivery | Assess antepartum depression using Edinburgh depression screening tool. Edinburgh score scale range is from 0 to 30, a lower score is better as it indicates a participant is less likely to experience depression; the test denotes the following scoring interpretations for total scores: 0-6: minimal depression, 7-13: mild depression, 14-19: moderate depression, 19-30: severe depression. Reporting mean score for the antepartum phase of the study; participants were 14-28 weeks gestation at their study enrollment visit and mean gestational age at delivery for the doula-enhanced group was 37 weeks 5days and 38 weeks 1day for the routine care group. |
| Postpartum Depression | Birth (delivery) through 6-weeks postpartum | Assess postpartum depression using Edinburgh depression screening tool. Edinburgh score scale range is from 0 to 30, a lower score is better as it indicates a participant is less likely to experience depression; the test denotes the following scoring interpretations for total scores: 0-6: minimal depression, 7-13: mild depression, 14-19: moderate depression, 19-30: severe depression. Reporting mean score for the postpartum phase in study participation starting post-delivery during their hospital admission until 6-weeks postpartum. |
| Maternal Pain Management | Delivery through hospital discharge | Assess pain management by using the Numerical Rating Scale (NRS) was used for patient's perception of postpartum pain. Zero (0) is the minimum score, which represents the patient reporting no pain, 10 is the maximum score which represents the patient reporting the most intense pain possible. Lower scores are associated with lower postpartum pain perception (better outcome) and higher scores are associated with higher postpartum pain perception (worse outcome) from delivery (mean gestational age at delivery for the doula-enhanced group was 37 weeks 5days and 38 weeks 1day for the routine care group) until hospital discharge. |
| Lactation Status - Number of Participants Lactating and Breastfeeding | Birth | Assess lactation status by asking and recording participants response about initiating lactation and breastfeeding during their labor and delivery admission. |
| Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge | Birth through 6-weeks postpartum | Assess lactation status from birth after labor and delivery discharge to 6-week postpartum, by asking and recording participants' responses about their lactation and breastfeed state during their postpartum visits. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngela Martin, MD
University of Kansas Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Advanced Maternal Age (AMA) | 1 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 29 years |
| History of Cesarean Section | 3 Participants |
| Nulliparous | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
None listed