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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental |
| |
| Routine Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of initial LARC utilization | Number of subjects who elect to have LARC procedure between the 2 arms | 12 weeks postpartum (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37141601 | Derived | 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. | |
| 35594122 | 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. |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Routine Care | Behavioral | The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options. |
|
Number of patients who become pregnant after enrollment pregnancy |
| 24 months |