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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04291040

Collaborator

Merck Sharp & Dohme LLC (Industry)

380

Enrollment

Location

Arms

48.7

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, High Risk Contraception	Behavioral: Decision Aid Behavioral: Routine Care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 9, 2020

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision Aid	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.
Active Comparator: Routine Care	Behavioral: Routine Care The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.

Arm

Intervention/Treatment

Experimental: Decision Aid

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.

Active Comparator: Routine Care

Behavioral: Routine Care

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

Outcome Measures

Primary Outcome Measures

Rate of initial LARC utilization [12 weeks postpartum (12 weeks)]
Number of subjects who elect to have LARC procedure between the 2 arms

Secondary Outcome Measures

Number of patients who keep the LARC after placement [12 months]
Number of patients who keep the LARC after placement [24 months]
rates of short interval pregnancy [24 months]
Number of patients who become pregnant after enrollment pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emma Jean Qureshey, Clinical MFM Fellow, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04291040

Other Study ID Numbers:

HSC-MS-20-0022

First Posted:

Mar 2, 2020

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 16, 2021