Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting
NCT ID: NCT05859087
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
76 participants
INTERVENTIONAL
2018-02-26
2021-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bedside Family Planning Counseling
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.
Counseling
Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.
Flyer
Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.
Flyer
Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.
Routine care
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.
No interventions assigned to this group
Interventions
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Counseling
Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.
Flyer
Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Sutter Health
OTHER
Responsible Party
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Ryan Spielvogel
Principal Investigator
Principal Investigators
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Ryan Spielvogel, MD
Role: PRINCIPAL_INVESTIGATOR
Sutter Health
Locations
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Sutter Medical Center Sacramento
Sacramento, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Family14_SIMR_Spielvogel
Identifier Type: -
Identifier Source: org_study_id
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