Preconception Reproductive Knowledge Promotion (PREKNOP)
This trial is active, not recruiting.
|Treatments||knowing your body, healthy lifestyle|
|Collaborator||Robert Wood Johnson Foundation|
|Start date||February 2013|
|End date||September 2016|
|Trial size||120 participants|
|Trial identifier||NCT01849900, 70315|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.
time frame: Baseline, 3, 6, 12, 18 and 24 months
Change from baseline number of unplanned pregnancies
time frame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months
Female participants from 18 years up to 44 years old.
Inclusion Criteria: - low-income women of childbearing age Exclusion Criteria: - Menopause - Hysterectomy
|Official title||Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention|
|Principal investigator||Adejoke B Ayoola, RN, PhD|
|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.|
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