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

Not Applicable

Active, not recruiting

• Conditions: Pregnancy, High Risk; Contraception
• Interventions: Behavioral: Decision Aid; Behavioral: Routine Care

• Registration Number: NCT04291040
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

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 Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Start: 2020-07-09
• Primary Completion: 2021-05-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Aid	Decision Aid	-
Routine Care	Routine Care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
rates of short interval pregnancy	24 months	Number of patients who become pregnant after enrollment pregnancy
Number of patients who keep the LARC after placement	24 months

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States