Preconception Reproductive Knowledge Promotion (PREKNOP)

Not Applicable

• Conditions: Pregnancy
• Interventions: Other: Knowing your body; Behavioral: Healthy Lifestyle

• Registration Number: NCT01849900
• Lead Sponsor: Calvin College

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11
• Primary Completion: 2017-04-30
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• low-income women of childbearing age

Exclusion Criteria

• Menopause
• Hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knowing your body	Knowing your body	60 women randomly assigned to intervention group
Healthy Lifestyle	Healthy Lifestyle	60 women randomly assigned to the control group
Knowing your body	Healthy Lifestyle	60 women randomly assigned to intervention group

Primary Outcome Measures

Name	Time	Method
Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.	Baseline, 3, 6, 12, 18 and 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline number of unplanned pregnancies	Baseline, 3 months, 6 months, 12 months, 18months, 24 months	The investigators will measure if there is a change in the number of unplanned pregnancies among the intervention group compared to the control group.

Trial Locations

Locations (1)

Calvin College Nursing Department Community sites; 🇺🇸 Grand Rapids, Michigan, United States