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

NCT04291040 | Unknown

• 1 other identifier: HSC-MS-20-0022
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, High Risk; Contraception

Outcome Measures

Primary Outcomes (1)

• Rate of initial LARC utilization

  Number of subjects who elect to have LARC procedure between the 2 arms

  12 weeks postpartum (12 weeks)

Secondary Outcomes (3)

• 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

Study Arms (2)

Decision Aid

EXPERIMENTAL

Behavioral: Decision Aid

Routine Care

ACTIVE COMPARATOR

Behavioral: Routine Care

Interventions

Decision Aid BEHAVIORAL

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.

Decision Aid

Routine Care BEHAVIORAL

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

Routine Care

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 13-50 years old
• High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Qureshey EJ, Ibarra CJ, Wagner SM, Chen HY, Ashimi S, Ross PJ, Blackwell SC, Sibai BM, Chauhan SP. Effect of a Multimedia Educational Tool on Contraception Use 1 Year Postpartum. Obstet Gynecol. 2023 Jun 1;141(6):1206-1208. doi: 10.1097/AOG.0000000000005198. Epub 2023 May 3.

  PMID: 37141601 DERIVED

• Qureshey EJ, Chauhan SP, Wagner SM, Batiste O, Chen HY, Ashimi S, Ross PJ, Blackwell SC, Sibai BM. Educational Multimedia Tool Compared With Routine Care for the Uptake of Postpartum Long-Acting Reversible Contraception in Individuals With High-Risk Pregnancies: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):571-578. doi: 10.1097/AOG.0000000000004718. Epub 2022 Mar 10.

  PMID: 35594122 DERIVED

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical MFM Fellow

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: July 9, 2020
• Primary Completion: May 26, 2021
• Study Completion: January 30, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)