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

Contraception Clinical Trial

— SUSTAIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04291040
• Other study ID #: HSC-MS-20-0022
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: November 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: January 30, 2023
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Pregnancy, High Risk

Intervention

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.
• Routine Care
The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of initial LARC utilization	Number of subjects who elect to have LARC procedure between the 2 arms	12 weeks postpartum (12 weeks)
Secondary	Number of patients who keep the LARC after placement		12 months
Secondary	Number of patients who keep the LARC after placement		24 months
Secondary	rates of short interval pregnancy	Number of patients who become pregnant after enrollment pregnancy	24 months