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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04291040
Other study ID # HSC-MS-20-0022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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