ContraceptionNCT03956030
Effect of Formal Contraception Handouts
A study testing Contraception Handout and Nutritional Handout in people with Contraception and Counseling, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The hypothesis of this study is to determine if distribution of a standardized educational handout on contraceptive options given to patients in the prenatal office setting will increase contraception use six months postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception, Counseling
- What is being tested?
- Contraception Handout and Nutritional Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are pregnant and are 24-28 weeks gestational age at the time of recruitment
- Women >18 years of age
- Women with low-risk pregnancies
Who cannot join
- Women who receive prenatal care by the Maternal Fetal Medicine department for high-risk pregnancies
- Women who are members of an at-risk population including any women who is a prisoner, cannot provide consent, or is <18 years of age
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Formal Contraception Handouts on Postpartum Birth Control Use and Methods
The hypothesis of this study is to determine if distribution of a standardized educational handout on contraceptive options given to patients in the prenatal office setting will increase contraception use six months postpartum.
Read the detailed description
Reducing unintended pregnancies and those that are conceived within 18 months of a previous livebirth is an important health concern in the United States. Both unintended and close-interval pregnancies constitute 40% and 35% of pregnancies in the United States respectively with some overlap between the two categories and are associated with adverse maternal and fetal outcomes. A national survey found that 17.8% of women using 'less-effective' methods and 23% of women using no birth control became pregnant in ≤18 months2. Access to better contraception education could potentially decrease the proportion of unintended pregnancies and close-interval pregnancies. In addition to the health concerns, 58% of women in the US would like more information about contraceptive options, and organized handouts on birth control have been shown to contribute to the choice in birth control. However, there has been conflicting evidence about which educational methods increase postpartum contraception use. Therefore, the investigators propose a randomized controlled trial (RCT) that assesses whether a handout on contraception options increases postpartum birth control use. The control group would receive a nutrition handout, and the intervention group would receive a handout on birth control options in addition to each receiving the standard of care. The researchers would also give pre- and post-natal questionnaires, covering patient satisfaction, intention to use birth control, and how often a provider discusses birth control options.
- Conditions
- Contraception, Counseling
- Being tested
- Contraception Handout, Nutritional Handout
- Keywords
- Female Contraception, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraception HandoutOther
Handout covering contraception options
Nutritional HandoutOther
Handout covering nutrition
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive educational handout on contraception. Receives: Other: Contraception Handout |
| Control | Experimental | Control group will receive educational handout on nutrition. Receives: Other: Nutritional Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraception Use
Participants were sent a survey electronically at 8 weeks which asked the question "Now that you have delivered, are you currently using birth control? (yes or no)" The data table reflects the number who answered YES and the number who answered NO to this question per group.
Measured: 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start10 Sep 2020
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Why it stopped: Insufficient research staff to recruit and complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial in which the intervention group will receive an educational handout on contraception and the control group will receive a handout on nutrition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina DeAngelis, Milton S. Hershey Medical Center
- Investigators
- Christina DeAngelis, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956030
- Sponsor's protocol ID
- STUDY00012248
- Status last verified
- Mar 2023
- First submitted
- 16 May 2019
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Formal Contraception Handouts on Postpartum Birth Control Use and Methods
- ClinicalTrials.gov ID
- NCT03956030
- Acronym / sponsor ID
- STUDY00012248
- Conditions
- Contraception, Counseling
- Keywords
- Female Contraception, Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient research staff to recruit and complete study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is to determine if distribution of a standardized educational handout on contraceptive options given to patients in the prenatal office setting will increase contraception use six months postpartum.
Detailed description
Reducing unintended pregnancies and those that are conceived within 18 months of a previous livebirth is an important health concern in the United States. Both unintended and close-interval pregnancies constitute 40% and 35% of pregnancies in the United States respectively with some overlap between the two categories and are associated with adverse maternal and fetal outcomes. A national survey found that 17.8% of women using 'less-effective' methods and 23% of women using no birth control became pregnant in ≤18 months2. Access to better contraception education could potentially decrease the proportion of unintended pregnancies and close-interval pregnancies. In addition to the health concerns, 58% of women in the US would like more information about contraceptive options, and organized handouts on birth control have been shown to contribute to the choice in birth control. However, there has been conflicting evidence about which educational methods increase postpartum contraception use. Therefore, the investigators propose a randomized controlled trial (RCT) that assesses whether a handout on contraception options increases postpartum birth control use. The control group would receive a nutrition handout, and the intervention group would receive a handout on birth control options in addition to each receiving the standard of care. The researchers would also give pre- and post-natal questionnaires, covering patient satisfaction, intention to use birth control, and how often a provider discusses birth control options.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial in which the intervention group will receive an educational handout on contraception and the control group will receive a handout on nutrition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Contraception HandoutIntervention group will receive educational handout on contraception. |
| Control | Experimental | Other: Nutritional HandoutControl group will receive educational handout on nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are pregnant and are 24-28 weeks gestational age at the time of recruitment
- Women >18 years of age
- Women with low-risk pregnancies
Key exclusion criteria (3 listed)
- Women who receive prenatal care by the Maternal Fetal Medicine department for high-risk pregnancies
- Women who are members of an at-risk population including any women who is a prisoner, cannot provide consent, or is <18 years of age
- Non-English speaking
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 |
|---|---|---|
| Contraception HandoutHandout covering contraception options | Other | Intervention |
| Nutritional HandoutHandout covering nutrition | Other | Control |
Primary outcome
Contraception Use
Time frame: 8 weeks postpartum
Participants were sent a survey electronically at 8 weeks which asked the question "Now that you have delivered, are you currently using birth control? (yes or no)" The data table reflects the number who answered YES and the number who answered NO to this question per group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Christina DeAngelis, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraception Handout and Nutritional Handout in people with Contraception and Counseling, run by Milton S. Hershey Medical Center 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Contraception Use (time frame: 8 weeks postpartum). 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 30 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.