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临床试验/NCT07214012
NCT07214012招募中不适用

Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families

University of Tennessee Graduate School of Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Feasibility of Study Procedures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Inclusion Criteria:
  • > 20 weeks pregnant, age 18+
  • 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
  • separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship
  • English-speaking
  • Romantic Partner Inclusion Criteria:
  • 18 years of age and older
  • Cohabiting with the patient; in a romantic relationship with patient
  • Capable of getting the patient pregnant after delivery
  • Does not need to be the biological father of the current pregnancy
  • English-speaking (in order to take part in the interview as the interviewer does not speak Spanish)

排除标准

  • Patient Exclusion Criteria:
  • Participant is under the age of 18
  • Documented cognitive impairment or psychiatric condition in pregnant person's medical record (e.g., severe learning disability, dementia, current psychotic disorder, suicidality)
  • Participation in a concurrent contraceptive education intervention
  • The pregnant person has a high-risk medical condition
  • Romantic Partner Exclusion Criteria:
  • Less than 18 years of age
  • Are not cohabiting with the patient; not in a romantic relationship with patient
  • Not capable of getting the patient pregnant after delivery

研究组 & 干预措施

Communication and Contraceptive Education Workbook (60-90 minutes)

Other

Asynchronous (during times convenient to the couple) (21-30 weeks gestation)

Follow-up survey at the end of session

干预措施: Joint contraceptive and couple communication education (Other)

Couple Contraceptive Consultation (60-90 minutes)

Other

In-person at OBGYN appt or telehealth (couple preference). ~ 32 weeks gestation

Follow-up survey at the end of session

干预措施: Couple communication consultation with Interventionist to increase partner engagement and improve communication (Other)

Booster Check-ins (~30 minutes)

Other

Telehealth/in-person (couple preference), ~6 weeks postpartum

Follow-up survey at the end of sessions

干预措施: Check-ins to support continued partner support & communication (Other)

Booster Check-ins (~30 minutes.)

Other

Telehealth/in-person (couple preference), ~12 weeks postpartum

Follow-up surveys at the end of session

干预措施: Check-ins to support continued partner support & communication (Other)

结局指标

主要结局

Feasibility of Study Procedures

时间窗: 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)

Acceptability of the Intervention

时间窗: 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

时间窗: 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

时间窗: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

Assessed with the Communication Problems Questionnaire (CPQ)

Community Referral Utilization

时间窗: 32 weeks gestation to 12 weeks postpartum

Community Referral Utilization and Satisfaction Questionnaire Scale (4 items validated by Dr. Roberson with economically marginalized couples

次要结局

  • Consistent Contraceptive Usage(6-week postpartum and 12-week postpartum)
  • Satisfaction with Agreed Contraceptive Method(6-week postpartum and 12-week postpartum)
  • Relationship Satisfaction(Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum)
  • Psychological Distress - Anxiety(Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum)
  • Psychological Distress - Depression(Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum)
  • Relationship Aggression(Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum)

研究者

发起方
University of Tennessee Graduate School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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