Clinical trial NCT01849900: Preconception Reproductive Knowledge Promotion (PREKNOP)
Official title: Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Menstrual cycle
Ovulation time
pregnancy recognition
Community-based participatory research
Unintended pregnancy
Lead sponsor: Calvin College
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2013-05-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* low-income women of childbearing age

Exclusion Criteria:

* Menopause
* Hysterectomy

Primary outcomes:
measure: Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.
timeFrame: Baseline, 3, 6, 12, 18 and 24 months
Secondary outcomes:
measure: Change from baseline number of unplanned pregnancies
timeFrame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months
Other outcomes:
measure: Change in self-efficacy about reproductive knowledge and pregnancy planning ability
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Locations:
city: Grand Rapids
country: United States
facility: Calvin College Nursing Department Community sites
state: Michigan
Study officials:
affiliation: Calvin College
name: Adejoke B Ayoola, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayoola AB, Nettleman M, Brewer J. Reasons for unprotected intercourse in adult women. J Womens Health (Larchmt). 2007 Apr;16(3):302-10. doi: 10.1089/jwh.2007.0210.
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. doi: 10.1016/j.contraception.2007.01.011. Epub 2007 Mar 12.
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.
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.
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.
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.