ContraceptionNCT05550064
Structured Contraceptive Counseling During Pregnancy
A study testing Structured contraceptive counseling in people with Contraception and Intrauterine Device, run by Dalarna University at 4 sites in Sweden.
Trial summary
Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Intrauterine Device, Contraceptive Implant
- What is being tested?
- Structured contraceptive counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesSweden
- Study dates
- 19 Nov 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, gestational week 30 or more, need for contraception 6 months or more after delivery
Who cannot join
- Language barrier that affects participation when an interpreter is not available, assisted fertilization, planned sterilization of partner, use of contraception for other purposes than pregnancy prevention.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Health Care Region Dalarna
Falun
Sara Hogmark, MD
- Recruiting
Health Care Region Värmland
Karlstad
Karin Ängeby, PhD
- Recruiting
Health Care Region Örebro Län
Örebro
Yvonne Skogsdal, PhD
- Recruiting
Health Care Region Uppsala
Uppsala
Lena Axén, RNM
About this study
Official title: Evaluating Effects of Prepartum Structured Contraceptive Counseling to Increase Postpartum Use of Long-acting Reversible Contraception
Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth.
This is a prospective observational intervention study, aiming to evaluate the effects of structured contraceptive counseling during pregnancy on uptake of contraception postpartum and more specifically on long-acting reversible contraceptive methods, and to identify and explore the provider's and patient's experiences of structured contraceptive counseling during pregnancy.
- Conditions
- Contraception, Intrauterine Device, Contraceptive Implant, Long-acting Reversible Contraception, Counseling
- Being tested
- Structured contraceptive counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured contraceptive counselingOther
- Educational video - healthcare providers (Medical doctors and nurse-midwives)present available contraceptives that could be used after delivery, with emphasis on effectiveness, how they should be used, mechanism of action and health benefits.
- The four key questions are to be asked to all pregnant women to make them reflect on factors that highly affects choice of contraceptives.
- A tiered effectiveness chart will be used to visualize the effectiveness of different contraceptives, and guide the prospective user in her choice depending on the answers to the key questions
- The box of contraceptive models are used for the prospective user to inspect, hold, feel the different contraceptives, as this has been shown to decrease fear regarding specific methods.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Evidence-based intervention for SCC, previously evaluated in a cluster randomized trial (doi:10.1111/1471-0528.16754) The intervention for prepartum SCC will consist of four different parts, adjusted to suit pregnant women with emphasis on immediate start when applicable:
1. An educational video presenting available contraceptive methods
2. 4 Key questions concerning how to deal with a new pregnancy, reproductive life plan, and additional health benefits from using contraception.
3. A tiered effectiveness chart of available contraceptives
4. A box of contraceptive models Receives: Other: Structured contraceptive counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy.
Percentage
Measured: 6 months post partum
Secondary outcomes (2)
New pregnancy
Categorical (yes/no)
Measured: 6, 12, 18, and 24 months postpartum
Outcome of new pregnancy
Categorical (yes/no) for planing to keep; kept; misscarriage; ectopic pregnancy; planning abortion; had an abotion
Measured: 6, 12, 18, nd 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start19 Nov 2022
- Primary completion19 Jun 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pregnant women will receive an intervention for structured contraceptive counseling from participating clinics. Follow-up will be through e-surveys at 6, 12, 18, and 24 months postpartum
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Envall, Dalarna University
- Investigators
- Niklas Envall, PhD, Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550064
- Sponsor's protocol ID
- SPR1
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, de-identified data might be shared with other researchers that share the purpose of this trial
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effects of Prepartum Structured Contraceptive Counseling to Increase Postpartum Use of Long-acting Reversible Contraception
- ClinicalTrials.gov ID
- NCT05550064
- Acronym / sponsor ID
- SPR1
- Conditions
- Contraception, Intrauterine Device, Contraceptive Implant, Long-acting Reversible Contraception, Counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Sep 2022 (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.
Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth.
This is a prospective observational intervention study, aiming to evaluate the effects of structured contraceptive counseling during pregnancy on uptake of contraception postpartum and more specifically on long-acting reversible contraceptive methods, and to identify and explore the provider's and patient's experiences of structured contraceptive counseling during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant women will receive an intervention for structured contraceptive counseling from participating clinics. Follow-up will be through e-surveys at 6, 12, 18, and 24 months postpartum
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Structured contraceptive counselingEvidence-based intervention for SCC, previously evaluated in a cluster randomized trial (doi:10.1111/1471-0528.16754) The intervention for prepartum SCC will consist of four different parts, adjusted to suit pregnant women with emphasis on immediate start when applicable: 1. An educational video presenting available contraceptive methods 2. 4 Key questions concerning how to deal with a new pregnancy, reproductive life plan, and additional health benefits from using contraception. 3. A tiered effectiveness chart of available contraceptives 4. A box of contraceptive models |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, gestational week 30 or more, need for contraception 6 months or more after delivery
Key exclusion criteria (1 listed)
- Language barrier that affects participation when an interpreter is not available, assisted fertilization, planned sterilization of partner, use of contraception for other purposes than pregnancy prevention.
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 |
|---|---|---|
| Structured contraceptive counseling1. Educational video - healthcare providers (Medical doctors and nurse-midwives)present available contraceptives that could be used after delivery, with emphasis on effectiveness, how they should be used, mechanism of action and health benefits. 2. The four key questions are to be asked to all pregnant women to make them reflect on factors that highly affects choice of contraceptives. 3. A tiered effectiveness chart will be used to visualize the effectiveness of different contraceptives, and guide the prospective user in her choice depending on the answers to the key questions 4. The box of contraceptive models are used for the prospective user to inspect, hold, feel the different contraceptives, as this has been shown to decrease fear regarding specific methods. | Other | Intervention arm |
Primary outcome
Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy.
Time frame: 6 months post partum
Percentage
2 secondary outcomes
New pregnancy
Time frame: 6, 12, 18, and 24 months postpartum
Outcome of new pregnancy
Time frame: 6, 12, 18, nd 24 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. Upon request, de-identified data might be shared with other researchers that share the purpose of this trial
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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.
Niklas Envall, PhD principal investigator
Dalarna University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured contraceptive counseling in people with Contraception and Intrauterine Device, run by Dalarna University at 4 sites in Sweden.
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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niklas Envall, PhD (+46704090925, nen@du.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy. (time frame: 6 months post partum). 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 10 Sep 2025.