Method of ContraceptionNCT01864629
Optimizing Postpartum Contraception in Women With Preterm Births
A study testing Focused contraception counseling in people with Method of Contraception and Preterm Birth Recurrence, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during… Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Method of Contraception, Preterm Birth Recurrence
- What is being tested?
- Focused contraception counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2016
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution.
Who cannot join
- Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.
The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.
- Conditions
- Method of Contraception, Preterm Birth Recurrence
- Being tested
- Focused contraception counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused contraception counselingBehavioural
This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Contraception after preterm birth | Other | Intervention name: Focused contraception counseling This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy. Receives: Behavioral: Focused contraception counseling |
| Control Group | No intervention | Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of highly effective method
Measured: Three months
Secondary outcomes (2)
Pregnancy outcomes
Measured: 12 months, 18 months, 24 months, 36 months
Use of highly effective method
Measured: 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Method of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David K Turok, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864629
- Sponsor's protocol ID
- IRB_00061119
- Status last verified
- Oct 2017
- First submitted
- 11 May 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postpartum Contraception in Women With Preterm Births
- ClinicalTrials.gov ID
- NCT01864629
- Acronym / sponsor ID
- IRB_00061119
- Conditions
- Method of Contraception, Preterm Birth Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 May 2013 (estimated)
- 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 this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.
The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraception after preterm birth | Other | Behavioral: Focused contraception counselingIntervention name: Focused contraception counseling This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy. |
| Control Group | No intervention | –Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution.
Key exclusion criteria (1 listed)
- Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.
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 |
|---|---|---|
| Focused contraception counselingThis intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy. | Behavioural | Contraception after preterm birth |
Primary outcome
Use of highly effective method
Time frame: Three months
2 secondary outcomes
Pregnancy outcomes
Time frame: 12 months, 18 months, 24 months, 36 months
Use of highly effective method
Time frame: 12 months, 24 months, 36 months
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 26 Oct 2017.
- 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.
David K Turok, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused contraception counseling in people with Method of Contraception and Preterm Birth Recurrence, run by University of Utah 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 1 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 26 Oct 2017. 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?
Use of highly effective method (time frame: Three months). 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 26 Oct 2017.