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Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas

University of Kansas logo

University of Kansas

Status

Completed

Conditions

Prenatal Care
Doula Care
Pregnancy Related
Black Maternal and Infant Health

Treatments

Behavioral: Doula Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07157059
IRB STUDY00149318 (Other Identifier)
FP00000002 (Other Grant/Funding Number)
STUDY00161314

Details and patient eligibility

About

The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.

Enrollment

30 patients

Sex

Female

Ages

16 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Doula-Enhanced Care Group
Experimental group
Description:
This group received doula-enhanced care along with routine pregnancy care.
Treatment:
Behavioral: Doula Care
Routine Pregnancy Care Group
No Intervention group
Description:
This group received routine pregnancy care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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