Induced; Birth
Conditions
Brief summary
This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians regarding induction methods.
Detailed description
This is a multi-phased study of patients undergoing IOL. Only the second phase of the study will be detailed in this protocol, as this will be the RCT portion of the study's design. We will test the efficacy of the visual aid by conducting a randomized trial of routine counseling versus counseling with the use of a visual aid (informed by patient interviews in the first phase) at the time of admission for IOL and studying the effect of the visual aid on patient knowledge, trust in providers, and satisfaction.
Interventions
OTHERVisual aid
Handout and video describing different types of induction of labor
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Using a web-based randomization sequence on REDCap, patients will be randomized in 1:1 ratio to standard counseling or counseling with a visual aid immediately prior to initiation of their IOL.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language.
Exclusion criteria
* Patients undergoing induction termination or with a history of prior cesarean section, major fetal anomaly, known chromosomal anomaly, or fetal growth restriction with doppler abnormalities. Patients whose induction has already commenced will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction of Labor Knowledge | After receiving intervention | Percentage of correct answers on survey measure of IOL knowledge adapted from Rahman et al (2022) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With IOL Counseling | After receiving intervention | 0-10 scale; higher scores indicate higher satisfaction |
| Patient Trust in Providers Survey | 10 minutes (during completion of survey) | Patients' self-reported trust in providers using a 10-item survey |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNandini Raghuraman, MD, MS
WashU Medicine
Participant flow
Pre-assignment details
Enrolled participant not randomized due to randomization goal being reached, n=1
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 5 |
| Currently Employed No | 24 Participants |
| Currently Employed Yes | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Gestational age at induction | 39.1 weeks |
| Indication for Induction Chronic hypertension | 3 Participants |
| Indication for Induction Fetal decelerations | 1 Participants |
| Indication for Induction Fetal growth restriction | 2 Participants |
| Indication for Induction Gestational hypertension | 5 Participants |
| Indication for Induction Other | 2 Participants |
| Indication for Induction Pre-eclampsia | 2 Participants |
| Indication for Induction Risk reducing | 53 Participants |
| Indication for Induction Type I or Type II Diabetes | 0 Participants |
| Insurance Type Commercial | 30 Participants |
| Insurance Type Public | 24 Participants |
| Level of Education 4+ Year Degree | 49 Participants |
| Level of Education Less than or equal to High School/GED | 18 Participants |
| Level of Education Some college/Associate's degree | 17 Participants |
| Marital Status Married/Partnered | 58 Participants |
| Marital Status Single | 24 Participants |
| Maternal BMI | 28.3 kg/m^2 |
| Medical Comorbidities Chronic Hypertension | 5 Participants |
| Medical Comorbidities Gestational Diabetes | 3 Participants |
| Medical Comorbidities Hypertensive disorders of pregnancy | 13 Participants |
| Nulliparous | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 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 | 26 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
| Substance Use Alcohol | 1 Participants |
| Substance Use Other Substance | 1 Participants |
| Substance Use Tobacco | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
None listed