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

The University of Texas Health Science Center, Houston380 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

380

Conditions

Pregnancy, High Risk Contraception

Interventions

Decision AidBEHAVIORAL

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 CareBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Rate of initial LARC utilization

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

Time frame: 12 weeks postpartum (12 weeks)

Secondary Outcomes

Number of patients who keep the LARC after placement

Time frame: 12 months

Number of patients who keep the LARC after placement

Time frame: 24 months

rates of short interval pregnancy

Number of patients who become pregnant after enrollment pregnancy

Time frame: 24 months

Data from ClinicalTrials.gov

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