Chronic DiseaseNCT05859087

Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting

A study testing Counseling and Flyer in people with Chronic Disease, run by Sutter Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Chronic Disease
What is being tested?: Counseling and Flyer
Type of treatment: Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2018to 27 May 2021
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 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Currently admitted to the hospital
Has one or more qualifying chronic medication conditions listed in their chart (hypertension, obesity with BMI>35, diabetes, current or history of breast cancer, rheumatoid arthritis, sickle cell disease, or lupus)

Who cannot join

Currently pregnant
Using surgical or non-surgical contraception
Immediately post-partum or admitted to the gynecology service
Non-English speaking
Non-verbal or too ill to consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Sutter Medical Center Sacramento
Sacramento, California, 95816

Other trials in United States

About this study

Official title: The Feasibility of Providing Family Planning Counseling Services for Women With Chronic Medical Conditions in an Inpatient Setting

Women with chronic medical conditions have been found in multiple studies to use birth control less often compared to women without chronic medical conditions. The investigators hypothesized that approaching women with chronic medical conditions who were admitted to the hospital and having a bedside conversation about pregnancy intention and counseling regarding birth control usage along with offering to start birth control before discharge would increase the use of birth control in this population. As a separate intervention, the investigators hypothesized that having a brief conversation with the participants and then giving them a flyer that recommended talking with their doctor about birth control could also increase the use of birth control in this population.

Conditions: Chronic Disease
Being tested: Counseling, Flyer
Keywords: Contraception, Access to Contraception, Health Inequities, Acute Care Setting, Inpatient
Medical subject headings: Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CounselingBehavioural
Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.
FlyerBehavioural
Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.

Study groups in NCT05859087
Study group	Role	What they receive
Bedside Family Planning Counseling	Experimental	Patient is screened for pregnancy intention and then has a bedside family planning counseling session with the investigator taking into account pregnancy intention, medical conditions, medications, and previous contraception used. At the end of the conversation, if patient is desiring contraception, the patient is offered three contraception options (as appropriate for their medical conditions and paid for as part of the study) to be initiated prior to discharge: Etonogestrel implant, medroxyprogesterone 150 mg IM injection, or a year's supply of oral contraception pills. Receives: Behavioral: Counseling
Flyer	Experimental	Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician. Receives: Behavioral: Flyer
Routine care	No intervention	Patients receive a deception consent so as not to influence them by the consent process. Consent states that the purpose of the project is to study patterns of birth control usage of women admitted to the hospital. Patient is not given any further intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Contraception use - 3 months
Number of patients using contraception 3 months post discharge as ascertained by telephone interview.
Measured: 3 months
Pregnancy - 3 months
Number of pregnancies 3 months post discharge as ascertained by telephone interview.
Measured: 3 months
Contraception use - 12 months
Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
Measured: 12 months
Pregnancy - 12 months
Number of pregnancies 12 months post discharge as ascertained by telephone interview.
Measured: 12 months

Secondary outcomes (3)

General contraception usage
Percent of study population using contraception at time of screening
Measured: up to 5 minutes
EHR accuracy
Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage
Measured: up to 5 minutes
Contraception initiation
Number of patients in the counseling arm who initiated contraception immediately after study intervention
Measured: up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 201827 May 2021

First posted15 May 2023
Study start26 Feb 2018
Primary completion27 May 2021
Study completion27 May 2021

Why it stopped: High attrition.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Chronic DiseaseStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1:1 randomized controlled trial
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05859087
Sponsor's protocol ID: Family14_SIMR_Spielvogel
Status last verified: May 2023
First submitted: 24 Apr 2023
Last updated: 15 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
PubMed 24314113
Vahratian A, Barber JS, Lawrence JM, Kim C. Family-planning practices among women with diabetes and overweight and obese women in the 2002 National Survey For Family Growth. Diabetes Care. 2009 Jun;32(6):1026-31. doi: 10.2337/dc08-2105. Epub 2009 Mar 11.
PubMed 19279299
Kaemmerer M, Vigl M, Seifert-Klauss V, Nagdyman N, Bauer U, Schneider KT, Kaemmerer H. Counseling reproductive health issues in women with congenital heart disease. Clin Res Cardiol. 2012 Nov;101(11):901-7. doi: 10.1007/s00392-012-0474-9. Epub 2012 May 15.
PubMed 22584383
Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.
PubMed 25705843
Dominick SA, McLean MR, Whitcomb BW, Gorman JR, Mersereau JE, Bouknight JM, Su HI. Contraceptive Practices Among Female Cancer Survivors of Reproductive Age. Obstet Gynecol. 2015 Sep;126(3):498-507. doi: 10.1097/AOG.0000000000000963.
PubMed 26181090
Kendrick J, Sharma S, Holmen J, Palit S, Nuccio E, Chonchol M. Kidney disease and maternal and fetal outcomes in pregnancy. Am J Kidney Dis. 2015 Jul;66(1):55-9. doi: 10.1053/j.ajkd.2014.11.019. Epub 2015 Jan 16.
PubMed 25600490
Hink E, Bolte AC. Pregnancy outcomes in women with heart disease: Experience of a tertiary center in the Netherlands. Pregnancy Hypertens. 2015 Apr;5(2):165-70. doi: 10.1016/j.preghy.2014.12.001. Epub 2015 Jan 5.
PubMed 25943639
Ghaffari N, Srinivas SK, Durnwald CP. The multidisciplinary approach to the care of the obese parturient. Am J Obstet Gynecol. 2015 Sep;213(3):318-25. doi: 10.1016/j.ajog.2015.03.001. Epub 2015 Mar 4.
PubMed 25747546
Chuang CH, Chase GA, Bensyl DM, Weisman CS. Contraceptive use by diabetic and obese women. Womens Health Issues. 2005 Jul-Aug;15(4):167-73. doi: 10.1016/j.whi.2005.04.002.
PubMed 16051107
O'Brien SH, Klima J, Reed S, Chisolm D, Schwarz EB, Kelleher KJ. Hormonal contraception use and pregnancy in adolescents with sickle cell disease: analysis of Michigan Medicaid claims. Contraception. 2011 Feb;83(2):134-7. doi: 10.1016/j.contraception.2010.06.017.
PubMed 21237338
Lee JK, Parisi SM, Schwarz EB. Contraceptive Counseling and Use among Women with Poorer Health. J Womens Health Issues Care. 2013;2(1):103. doi: 10.4172/2325-9795.1000103.
PubMed 24971372
DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.
PubMed 24807345
Guth U, Huang DJ, Bitzer J, Moffat R. Unintended pregnancy during the first year after breast cancer diagnosis. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):290-4. doi: 10.1080/13625187.2016.1180678. Epub 2016 May 26.
PubMed 27227578
Spielvogel R, Stephens RB, Clark R, Guillen M, Hankins A, Parise C. Providing family planning counseling services for women with chronic medical conditions in an inpatient setting: A randomized feasibility trial. Contraception. 2023 Dec;128:110133. doi: 10.1016/j.contraception.2023.110133. Epub 2023 Aug 6.
PubMed 37549724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Feasibility of Providing Family Planning Counseling Services for Women With Chronic Medical Conditions in an Inpatient Setting
ClinicalTrials.gov ID: NCT05859087
Acronym / sponsor ID: Family14_SIMR_Spielvogel
Conditions: Chronic Disease
Keywords: Contraception, Access to Contraception, Health Inequities, Acute Care Setting, Inpatient
Study type: Interventional
Recruitment status: TerminatedReason stopped: High attrition.
Enrolment: 76 participants (actual)
Lead sponsor: Sutter HealthUniversity, hospital or other
Study start: 26 Feb 2018 (actual)
Primary completion: 27 May 2021 (actual)
Study completion: 27 May 2021 (actual)
First posted: 15 May 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 1:1:1 randomized controlled trial

Arm	Type	Receives
Bedside Family Planning Counseling	Experimental	Behavioral: CounselingPatient is screened for pregnancy intention and then has a bedside family planning counseling session with the investigator taking into account pregnancy intention, medical conditions, medications, and previous contraception used. At the end of the conversation, if patient is desiring contraception, the patient is offered three contraception options (as appropriate for their medical conditions and paid for as part of the study) to be initiated prior to discharge: Etonogestrel implant, medroxyprogesterone 150 mg IM injection, or a year's supply of oral contraception pills.
Flyer	Experimental	Behavioral: FlyerPatient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.
Routine care	No intervention	–Patients receive a deception consent so as not to influence them by the consent process. Consent states that the purpose of the project is to study patterns of birth control usage of women admitted to the hospital. Patient is not given any further intervention.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Currently admitted to the hospital
Has one or more qualifying chronic medication conditions listed in their chart (hypertension, obesity with BMI>35, diabetes, current or history of breast cancer, rheumatoid arthritis, sickle cell disease, or lupus)

Key exclusion criteria (5 listed)

Currently pregnant
Using surgical or non-surgical contraception
Immediately post-partum or admitted to the gynecology service
Non-English speaking
Non-verbal or too ill to consent

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
CounselingBedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.	Behavioural	Bedside Family Planning Counseling
FlyerHanding flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.	Behavioural	Flyer

Primary outcome

Contraception use - 3 months
Time frame: 3 months
Number of patients using contraception 3 months post discharge as ascertained by telephone interview.
Pregnancy - 3 months
Time frame: 3 months
Number of pregnancies 3 months post discharge as ascertained by telephone interview.
Contraception use - 12 months
Time frame: 12 months
Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
Pregnancy - 12 months
Time frame: 12 months
Number of pregnancies 12 months post discharge as ascertained by telephone interview.

3 secondary outcomes

General contraception usage
Time frame: up to 5 minutes
EHR accuracy
Time frame: up to 5 minutes
Contraception initiation
Time frame: up to 1 hour

Results and safety

The study was stopped early (reason given: High attrition.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
Background: PubMed 24314113Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
Background: PubMed 19279299Vahratian A, Barber JS, Lawrence JM, Kim C. Family-planning practices among women with diabetes and overweight and obese women in the 2002 National Survey For Family Growth. Diabetes Care. 2009 Jun;32(6):1026-31. doi: 10.2337/dc08-2105. Epub 2009 Mar 11.
Background: PubMed 22584383Kaemmerer M, Vigl M, Seifert-Klauss V, Nagdyman N, Bauer U, Schneider KT, Kaemmerer H. Counseling reproductive health issues in women with congenital heart disease. Clin Res Cardiol. 2012 Nov;101(11):901-7. doi: 10.1007/s00392-012-0474-9. Epub 2012 May 15.
Background: PubMed 25705843Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.
Background: PubMed 26181090Dominick SA, McLean MR, Whitcomb BW, Gorman JR, Mersereau JE, Bouknight JM, Su HI. Contraceptive Practices Among Female Cancer Survivors of Reproductive Age. Obstet Gynecol. 2015 Sep;126(3):498-507. doi: 10.1097/AOG.0000000000000963.
Background: PubMed 25600490Kendrick J, Sharma S, Holmen J, Palit S, Nuccio E, Chonchol M. Kidney disease and maternal and fetal outcomes in pregnancy. Am J Kidney Dis. 2015 Jul;66(1):55-9. doi: 10.1053/j.ajkd.2014.11.019. Epub 2015 Jan 16.
Background: PubMed 25943639Hink E, Bolte AC. Pregnancy outcomes in women with heart disease: Experience of a tertiary center in the Netherlands. Pregnancy Hypertens. 2015 Apr;5(2):165-70. doi: 10.1016/j.preghy.2014.12.001. Epub 2015 Jan 5.
Background: PubMed 25747546Ghaffari N, Srinivas SK, Durnwald CP. The multidisciplinary approach to the care of the obese parturient. Am J Obstet Gynecol. 2015 Sep;213(3):318-25. doi: 10.1016/j.ajog.2015.03.001. Epub 2015 Mar 4.
Background: PubMed 16051107Chuang CH, Chase GA, Bensyl DM, Weisman CS. Contraceptive use by diabetic and obese women. Womens Health Issues. 2005 Jul-Aug;15(4):167-73. doi: 10.1016/j.whi.2005.04.002.
Background: PubMed 21237338O'Brien SH, Klima J, Reed S, Chisolm D, Schwarz EB, Kelleher KJ. Hormonal contraception use and pregnancy in adolescents with sickle cell disease: analysis of Michigan Medicaid claims. Contraception. 2011 Feb;83(2):134-7. doi: 10.1016/j.contraception.2010.06.017.
Background: PubMed 24971372Lee JK, Parisi SM, Schwarz EB. Contraceptive Counseling and Use among Women with Poorer Health. J Womens Health Issues Care. 2013;2(1):103. doi: 10.4172/2325-9795.1000103.
Background: PubMed 24807345DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.
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.

Ryan Spielvogel, MD principal investigator

Sutter Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Counseling and Flyer in people with Chronic Disease, run by Sutter Health 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 5 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 15 May 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?

The study was stopped early (reason given: High attrition.). 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?

Contraception use - 3 months (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT05859087, which also lists 14 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 15 May 2023.