Prenatal Contraceptive Education for Close Pregnancy Spacing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee Graduate School of Medicine

Disqualifiers: Cognitive impairment, Psychiatric condition, High-risk condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Planning Together, designed to help couples learn about and plan for effective contraceptive use, aiming to improve communication and decision-making around family planning. The study will assess whether couples find the program helpful and easy to follow, focusing on boosting contraceptive knowledge and satisfaction. It seeks pregnant participants who are at least 20 weeks along, in a safe relationship, and living with a romantic partner who can communicate in English. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance family planning resources for many couples.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on contraceptive education and does not mention medication changes.

What prior data suggests that the Planning Together protocol is safe?

Research has shown that educational programs like "Planning Together" are generally well-received by participants. Studies have found that these programs enhance understanding and use of contraception, improving family planning. These sessions focus on educating couples, and no reports of physical side effects exist.

Since this trial involves educational sessions rather than medications or medical procedures, safety concerns are minimal. Participants in similar programs have reported satisfaction, and no negative effects from the learning activities are known.

This approach provides individuals with important information and support during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to educate couples about contraceptive options and improve communication to space pregnancies more effectively. Unlike traditional methods that focus solely on individual education, this trial emphasizes a couple-based approach, offering both a comprehensive workbook and a personalized consultation. These methods are designed to fit seamlessly into a couple's schedule, with the flexibility of in-person or telehealth sessions. This approach aims to empower couples with the knowledge and communication tools needed to make informed decisions, enhancing their ability to manage family planning proactively.

What evidence suggests that the Planning Together protocol is effective for improving contraceptive knowledge and communication?

Studies have shown that better prenatal care can lead to improved planning for birth control after a baby is born, increasing the likelihood that mothers will use birth control correctly. Research indicates that when couples receive quality education about relationships and birth control, they often opt for long-lasting birth control methods after childbirth. One study found that family planning programs reduce health risks for mothers by improving access to birth control and other health services. This trial will evaluate the Planning Together program, which includes approaches such as the Communication and Contraceptive Education Workbook and Couple Contraceptive Consultation, to help couples make informed decisions and enhance their use of birth control after having a baby. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for economically marginalized couples who are expecting a child and want to learn about family planning. They should be interested in improving communication with their partner and willing to engage in educational activities together.

Inclusion Criteria

Patient Inclusion Criteria:

The pregnant person reports being in a sexually, psychologically and physically safe relationship

Must be English-speaking

Exclusion Criteria

Patient Exclusion Criteria:

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey including demographics and validated measures related to contraceptive knowledge, couple communication, reproductive autonomy, and psychological well-being.

1 week

1 visit (in-person or virtual)

Intervention

Participants engage in a 4-session intervention including a Communication and Contraceptive Education Workbook and Couple Contraceptive Consultation.

12 weeks

4 sessions (in-person or virtual)

Booster Check-ins

Participants have booster check-ins at 6 weeks and 12 weeks postpartum to reinforce the intervention.

6 weeks

2 visits (in-person or virtual)

Follow-up

Participants are monitored for outcomes such as contraceptive knowledge, communication quality, and community referral utilization.

12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Planning Together

Trial Overview The 'Planning Together' program includes couple consultations, check-ins, and education on contraception and communication. The study aims to see if this approach helps couples plan pregnancies better and supports partner engagement.

How Is the Trial Designed?

Group I: Couple Contraceptive Consultation (60-90 minutes) Experimental Treatment 1 Intervention

In-person at OBGYN appt or telehealth (couple preference). \~ 32 weeks gestation Follow-up survey at the end of session

Group II: Communication and Contraceptive Education Workbook (60-90 minutes) Experimental Treatment 1 Intervention

Asynchronous (during times convenient to the couple) (21-30 weeks gestation) Follow-up survey at the end of session

Group III: Booster Check-ins (~30 minutes.) Experimental Treatment 1 Intervention

Telehealth/in-person (couple preference), \~12 weeks postpartum Follow-up surveys at the end of session

Group IV: Booster Check-ins (~30 minutes) Experimental Treatment 1 Intervention

Telehealth/in-person (couple preference), \~6 weeks postpartum Follow-up survey at the end of sessions

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials

17

Recruited

1,400+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10061321/

Impact of Prenatal Group Healthy Relationship Education on ... We aimed to evaluate the impact of an antenatal group healthy relationship education program on the postpartum use of long-acting reversible contraception ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155310/

Association of quality of prenatal care with contraceptive ... This study looks to examine the association of the quality of prenatal care with planned postpartum contraception.

3. pdfs.semanticscholar.org pdfs.semanticscholar.org/a853/2baa1b1340a075c5680e3ffd6d5682fbc174.pdf

Effectiveness of Family Planning Programs in Reducing ... The findings show that the Family Planning Program is effective in reducing maternal mortality through increasing access to reproductive health services, health.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782420304364

Factors influencing women's decisions about pregnancy ... The objective of this study was to improve understanding of women's motivations regarding pregnancy spacing.

5. ajog.org ajog.org/article/S0002-9378%2813%2902209-6/fulltext

Interpregnancy intervals: impact of postpartum ... We explored the effect of contraceptive method provision on the odds of having an optimal interpregnancy interval and controlled for covariates. Results. The ...

6. communitysolutions.com communitysolutions.com/resources/march-dimes-make-space-project

March of Dimes birth spacing project The goal of the project, was to improve birth spacing by better informing women about LARC, and improving provider confidence in counseling patients and ...

7. astho.org astho.org/4a4b54/globalassets/toolkit/advancing-contraceptive-care-to-improve-maternal-health-outcomes.pdf

advancing-contraceptive-care-to-improve-maternal-health- ... This targeted approach reduces unintended pregnancies, empowering people to make informed choices about family planning during a period of ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146000515000531

Impact of family planning programs in reducing high-risk ... Family planning programs are widely viewed as having contributed to substantial maternal and neonatal mortality decline through contraceptive use.

9. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.15127

Family planning saves maternal and newborn lives: Why ... We highlight why integrating contraceptive services within maternal and newborn health programs is essential for improving outcomes.