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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05859087
• Other study ID #: Family14_SIMR_Spielvogel
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: May 27, 2021

Study information

• Verified date: May 2023
• Source: Sutter Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Sutter Medical Center Sacramento	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Sutter Health

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraception use - 3 months	Number of patients using contraception 3 months post discharge as ascertained by telephone interview.	3 months
Primary	Pregnancy - 3 months	Number of pregnancies 3 months post discharge as ascertained by telephone interview.	3 months
Primary	Contraception use - 12 months	Number of patient using contraception 12 months post discharge as ascertained by telephone interview.	12 months
Primary	Pregnancy - 12 months	Number of pregnancies 12 months post discharge as ascertained by telephone interview.	12 months
Secondary	General contraception usage	Percent of study population using contraception at time of screening	up to 5 minutes
Secondary	EHR accuracy	Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage	up to 5 minutes
Secondary	Contraception initiation	Number of patients in the counseling arm who initiated contraception immediately after study intervention	up to 1 hour