Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN)
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Details and patient eligibility
About
The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.
Full description
This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum.
The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Aged 13-50 years old
- High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications
Exclusion criteria
- Planned cesarean hysterectomy
- Unable to provide informed consent in either English or Spanish
- Unable to provide reliable cell phone access for the study duration
- Not willing to provide follow-up for two years
Trial design
Primary purpose
Allocation
Interventional model
Masking
380 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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