Preconception Reproductive Knowledge Promotion (PREKNOP)

Pregnancy Clinical Trial

— PREKNOP  

Official title:

Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01849900
• Other study ID #: 70315
• Status: Active, not recruiting
• Phase: N/A
• First received: May 1, 2013
• Last updated: April 8, 2017
• Start date: February 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2017
• Source: Calvin College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the efficacy of the "Preconception Reproductive Knowledge Promotion (PREKNOP)" intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

Description:

This study is a randomized, controlled trial of the PREKNOP intervention in a sample of 120 women 18-44 years old. Teams of nursing students and community health workers will administer the 12-month intervention. In addition to 10 home visits during which women will receive information on the female reproductive system and the expected monthly cyclical changes, PREKNOP will consist of use of ovulation test kits, a 12-month menstrual calendar, a digital thermometer, and educational brochures covering: the female reproductive anatomy, hormones and menstrual cycle, how to recognize ovulation period, various methods of birth control and how they work, and early pregnancy symptoms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• low-income women of childbearing age

Exclusion Criteria:

• Menopause

• Hysterectomy

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Knowing your body
Women will receive the "Knowing your body" kit. The kit contains: 6 ovulation test strips, a 12 month menstrual log sheet/calendar, and a thermometer to help women determine their body temperature; and educational materials that contain information on female body parts involved in pregnancy, hormones and the menstrual cycle, how birth control works, body temperature changes, characteristics of cervical fluid, and adapting to pregnancy during the first trimester. Participants will receive a total of 10 visits. During the first visit, the nursing student/community health workers team will review the intervention kit and continue to discuss topics related to women's health during subsequent visits.

Behavioral:
• Healthy Lifestyle
Women will receive educational materials on healthy lifestyle such as maintaining good nutrition and the importance of folic acid for women of childbearing age during the first visit. Participants will receive a total of 10 visits. The nursing student/community health workers team will continue to discuss topics related to promoting healthy lifestyle during subsequent visits.

Locations

Country	Name	City	State
United States	Calvin College Nursing Department Community sites	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Calvin College	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ayoola AB, Nettleman M, Brewer J. Reasons for unprotected intercourse in adult women. J Womens Health (Larchmt). 2007 Apr;16(3):302-10. Review. — View Citation

Ayoola AB, Zandee GL, Johnson E, Pennings K. Contraceptive use among low-income women living in medically underserved neighborhoods. J Obstet Gynecol Neonatal Nurs. 2014 Jul-Aug;43(4):455-64. doi: 10.1111/1552-6909.12462. Epub 2014 Jun 24. — View Citation

Ayoola AB, Zandee GL. Low-income women's recommendations for promoting early pregnancy recognition. J Midwifery Womens Health. 2013 Jul-Aug;58(4):416-22. doi: 10.1111/jmwh.12078. Epub 2013 Jul 23. — View Citation

Dott M, Rasmussen SA, Hogue CJ, Reefhuis J; National Birth Defects Prevention Study.. Association between pregnancy intention and reproductive-health related behaviors before and after pregnancy recognition, National Birth Defects Prevention Study, 1997-2002. Matern Child Health J. 2010 May;14(3):373-81. doi: 10.1007/s10995-009-0458-1. Epub 2009 Feb 28. — View Citation

Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011 Nov;84(5):478-85. doi: 10.1016/j.contraception.2011.07.013. Epub 2011 Aug 24. — View Citation

Nettleman MD, Chung H, Brewer J, Ayoola A, Reed PL. Reasons for unprotected intercourse: analysis of the PRAMS survey. Contraception. 2007 May;75(5):361-6. Epub 2007 Mar 12. Erratum in: Contraception. 2007 Nov;76(5):413. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in self-efficacy about reproductive knowledge and pregnancy planning ability	The investigators will measure if there is an increase in self-efficacy score among the 120 participants in the study. The investigators will compare if there is higher increase among the 60 participants in the intervention group compared to the 60 participants in the control group.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Primary	Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.	The investigators will measure if there is an increase in reproductive knowledge of ovulation time, menstrual cycle, peak fertile times, and early signs of pregnancy among the 120 participants in the study. The investigators will compare if there is higher increase in knowledge among the intervention group compared to the 60 participants in control group.	Baseline, 3, 6, 12, 18 and 24 months
Secondary	Change from baseline number of unplanned pregnancies	The investigators will measure if there is a change in the number of unplanned pregnancies among the intervention group compared to the control group.	Baseline, 3 months, 6 months, 12 months, 18months, 24 months

External Links

•   Adejoke Ayoola, Ph.D., R.N. Selected as a 2012 Robert Wood Johnson Foundation Nurse Faculty Scholar
•   Nursing professor Joke Ayoola will work in three Calvin partner neighborhoods, increasing women's knowledge and self-efficacy about reproductive health.