Contraception, Pregnancy, High Risk
Conditions
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.
Interventions
BEHAVIORALDecision 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.
BEHAVIORALRoutine Care
The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.
Sponsors
Merck Sharp & Dohme LLC
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of initial LARC utilization | 12 weeks postpartum (12 weeks) | Number of subjects who elect to have LARC procedure between the 2 arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who keep the LARC after placement | 12 months | — |
| rates of short interval pregnancy | 24 months | Number of patients who become pregnant after enrollment pregnancy |
Countries
United States
Outcome results
None listed