Post Partum ContraceptionNCT03118726
Evaluation of Immediate Postpartum LARC Implementation Programs
An observational study of Post Partum Contraception, run by University of New Mexico at 1 site in United States.
Trial summary
This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post Partum Contraception
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 31 May 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design, with components being introduced to each hospital one at a time.
Who may be able to join
- Hospital staff: Important individuals at New Mexico hospitals planning to implement immediate postpartum LARC programs, with an emphasis on diversity of administrative perspectives.
- If more than 4 potential participants are identified at one institution, additional participants may be included if their participation in the study is likely to contribute additional information (e.g. job title or background is different from other study participants)
Who cannot join
- Inability to speak and read English proficiently
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design,with components being introduced to each hospital one at a time
- Conditions
- Post Partum Contraception
- Keywords
- LARC, New Mexico, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NM Perinatal Collaborative | Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline immediate postpartum LARC Implementation
To determine baseline immediate postpartum LARC implementation in various rural New Mexico hospitals.
Measured: April 2017-December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start13 Apr 2017
- Primary completion31 May 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum ContraceptionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hofler, University of New Mexico
- Investigators
- Lisa Hofler, MD, MBA, MPH, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118726
- Sponsor's protocol ID
- 17-051
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediate Postpartum LARC Implementation Programs
- ClinicalTrials.gov ID
- NCT03118726
- Acronym / sponsor ID
- 17-051
- Conditions
- Post Partum Contraception
- Keywords
- LARC, New Mexico, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 18 Apr 2017 (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.
This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design,with components being introduced to each hospital one at a time
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NM Perinatal Collaborative | – | –Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design, with components being introduced to each hospital one at a time.
Key inclusion criteria (2 listed)
- Hospital staff: Important individuals at New Mexico hospitals planning to implement immediate postpartum LARC programs, with an emphasis on diversity of administrative perspectives.
- If more than 4 potential participants are identified at one institution, additional participants may be included if their participation in the study is likely to contribute additional information (e.g. job title or background is different from other study participants)
Key exclusion criteria (1 listed)
- Inability to speak and read English proficiently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline immediate postpartum LARC Implementation
Time frame: April 2017-December 2018
To determine baseline immediate postpartum LARC implementation in various rural New Mexico hospitals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Post Partum Contraception
Active, not recruiting
Postpartum Family Planning Program in Rwanda
Family Planning
Recruiting
Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare
Family Dynamics, Trust in Healthcare System
Active, not recruitingObservational study
Women's Knowledge of Contraception During the Postpartum Period
Contraception
Recruiting
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
Substance Use Disorders, Pregnancy Related
Recruiting
Structured Contraceptive Counseling During Pregnancy
Contraception, Intrauterine Device
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.
Lisa Hofler, MD, MBA, MPH principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Contraception, run by University of New Mexico 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 1 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Baseline immediate postpartum LARC Implementation (time frame: April 2017-December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.