Pregnancy, High RiskSUSTAINNCT04291040
Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies
A study testing Decision Aid and Routine Care in people with Pregnancy, High Risk and Contraception, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Pregnancy, High Risk, Contraception
- What is being tested?
- Decision Aid and Routine Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 13-50 years old
- High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Pregnancy, High Risk, Contraception
- Being tested
- Decision Aid, Routine Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
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 CareBehavioural
The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | Not described Receives: Behavioral: Decision Aid |
| Routine Care | Active comparator | Not described Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of initial LARC utilization
Number of subjects who elect to have LARC procedure between the 2 arms
Measured: 12 weeks postpartum (12 weeks)
Secondary outcomes (3)
Number of patients who keep the LARC after placement
Measured: 12 months
Number of patients who keep the LARC after placement
Measured: 24 months
rates of short interval pregnancy
Number of patients who become pregnant after enrollment pregnancy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start9 Jul 2020
- Primary completion26 May 2021
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Emma Jean Qureshey, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291040
- Sponsor's protocol ID
- HSC-MS-20-0022
- Acronym
- SUSTAIN
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37141601Qureshey 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.
PubMed 35594122
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04291040
- Acronym / sponsor ID
- SUSTAIN / HSC-MS-20-0022
- Conditions
- Pregnancy, High Risk, Contraception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Behavioral: Decision Aid |
| Routine Care | Active comparator | Behavioral: Routine Care |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Aged 13-50 years old
- High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidFollowing 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. | Behavioural | Decision Aid |
| Routine CareThe control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options. | Behavioural | Routine Care |
Primary outcome
Rate of initial LARC utilization
Time frame: 12 weeks postpartum (12 weeks)
Number of subjects who elect to have LARC procedure between the 2 arms
3 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
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 37141601Qureshey 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.
- Derived from this study: PubMed 35594122Qureshey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid and Routine Care in people with Pregnancy, High Risk and Contraception, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of initial LARC utilization (time frame: 12 weeks postpartum (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291040, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.