NCT04291040

Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies

Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 13 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pregnancy, High Risk
• Contraception

Interventions

Type	Name	Description
BEHAVIORAL	Decision Aid	Following randomization, participants will independently view the multimedia based decision aid on a provided tablet. They will also receive provider counseling. For the remainder of the pregnancy, they will receive a text message with a link to the multimedia based presentation. This will occur every 4 weeks until 12 weeks postpartum.
BEHAVIORAL	Routine Care	The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.

Timeline

• Start date: 2020-07-09
• Primary completion: 2021-05-26
• Completion: 2023-01-30
• First posted: 2020-03-02
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States