Maternal Health Disparities, Short Interpregnancy Intervals
Conditions
Brief summary
The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol The hypothesis of this study are 1. The study will achieve feasibility, demonstrated by ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% (e.g., education workbook completion) 2. The intervention will be acceptable, with \>80% of participants reporting satisfaction with Planning Together. 3. Patterns of primary outcomes (contraceptive knowledge, communication quality, community referral utilization) and secondary outcomes (agreed contraceptive plan, consistent contraceptive usage and satisfaction, psychological distress, and Short Interpregnancy Intervals \[SII\]) will suggest benefits of the intervention.
Detailed description
This study addresses critical maternal health disparities by targeting SII, which are associated with adverse outcomes such as preterm birth, low birth weight, and preeclampsia. These risks are especially high in economically marginalized populations, particularly in the Southern U.S., where access to prenatal contraceptive education is limited. The "Planning Together" intervention is a culturally-responsive, couple-based approach that seeks to improve consistent, desired contraceptive use by addressing both social barriers (e.g., lack of partner involvement and poor communication) and structural barriers (e.g., food insecurity, housing instability). It combines flexible delivery (online and in-person options) with tailored community referrals and partner-inclusive contraceptive education. At approximately 20 weeks gestation, eligible pregnant participants will be recruited from the UT OBGYN Clinic, with their romantic partners recruited in-person or virtually. After informed consent, both participants will complete a baseline survey. This survey includes demographics and validated measures related to contraceptive knowledge, couple communication, reproductive autonomy, and psychological well-being. The visit also includes a social needs assessment using the Accountable Health Communities Screening Tool, which informs warm hand-off referrals during later sessions. The significance of this work lies in its potential to reduce maternal health disparities through a brief (4-session), sustainable intervention model. If proven feasible and acceptable, "Planning Together" could be scaled to other underserved or marginalized communities and applied to additional perinatal health issues traditionally assigned to the pregnant-capable person (e.g., infant vaccinations, breastfeeding, peripartum mood disorders), ultimately improving both infant and maternal health outcomes.
Interventions
OTHERJoint contraceptive and couple communication education
Joint Comprehensive Contraceptive Education a. Visual and written description of all currently available contraceptives with explanation of pros and cons Couple constructive communication education 1. Specific couple contraceptive conversation examples. 2. Interactive worksheet to help with joint desired contraceptive decision-making and making a consistent use plan
OTHERCouple communication consultation with Interventionist to increase partner engagement and improve communication
1. Couples will bring their completed workbook to reference during the meeting and assess fidelity 2. Reinforce couple contraceptive communication skills. Address any challenges couple has with skill implementation 3. Review desired contraceptive method \& consistent use plan 4. Use motivational interviewing techniques to help couple agree on contraceptive plan
OTHERCheck-ins to support continued partner support & communication
1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method 2. Assess factors promoting successful contraceptive use and communication skills 3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving
Sponsors
University of Tennessee Graduate School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: 1. \> 20 weeks pregnant, age 18+ 2. The pregnant person has an available romantic partner, and the couple was able to get pregnant on their own or will be able to after the delivery 3. separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship 4. English-speaking Romantic Partner Inclusion Criteria: 1. 18 years of age and older 2. Cohabiting with the patient; in a romantic relationship with patient 3. Capable of getting the patient pregnant after delivery 4. Does not need to be the biological father of the current pregnancy 5. English-speaking (in order to take part in the interview as the interviewer does not speak Spanish)
Exclusion criteria
Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Intervention | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured by survey item: \>80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire |
| Change in Contraceptive Knowledge | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured using the validated Contraceptive Knowledge tool |
| Change in Couple Communication Quality | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Assessed with the Communication Problems Questionnaire (CPQ) |
| Community Referral Utilization | 32 weeks gestation to 12 weeks postpartum | Community Referral Utilization and Satisfaction Questionnaire Scale (4 items validated by Dr. Roberson with economically marginalized couples |
| Feasibility of Study Procedures | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Defined as ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% fidelity (completion of workbook and study activities) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress - Anxiety | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured using PROMIS Anxiety short form |
| Consistent Contraceptive Usage | 6-week postpartum and 12-week postpartum | Measured by participant self-report on the Consistent Usage scale |
| Psychological Distress - Depression | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured using PROMIS Depression short form |
| Relationship Aggression | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured using the Conflict Tactic Scale (CTS) |
| Satisfaction with Agreed Contraceptive Method | 6-week postpartum and 12-week postpartum | Assessed via the validated Satisfaction of Agreed Method scale |
| Relationship Satisfaction | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum | Measured using the Couple Satisfaction Index (CSI) |
Countries
United States
Outcome results
None listed