NCT03893084 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

ACOG Committee on Genetics
ACOG Committee Opinion No. 442: Preconception and prenatal carrier screening for genetic diseases in individuals of Eastern European Jewish descent. Obstet Gynecol. 2009 Oct;114(4):950-3. doi: 10.1097/AOG.0b013e3181bd12f4.
Atrash HK, Johnson K, Adams M, Cordero JF, Howse J
Preconception care for improving perinatal outcomes: the time to act. Matern Child Health J. 2006 Sep;10(5 Suppl):S3-11. Epub 2006 Jun 14. Review.
Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, Sankar MJ, Blencowe H, Rizvi A, Chou VB, Walker N; Lancet Newborn Interventions Review Group; Lancet Every Newborn Study Group
Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014 Jul 26;384(9940):347-70. doi: 10.1016/S0140-6736(14)60792-3. Epub 2014 May 19. Review. Erratum in: Lancet. 2014 Jul 26;384(9940):308. Sankar, Jeeva M [corrected to Sankar, M Jeeva].
Committee on Obstetric Practice
ACOG Committee Opinion No. 521: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Obstet Gynecol. 2012 Mar;119(3):690-1. doi: 10.1097/AOG.0b013e31824e1327.
de Weerd S, Steegers EA
The past and present practices and continuing controversies of preconception care. Community Genet. 2002;5(1):50-60.
Schwarzer, R
, & Jerusalem, M. (1995). Generalized Self-Efficacy scale. J. Weinman, S. Wright, & M. Johnston (Eds.), Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37.).
Walker SN, Sechrist KR, Pender NJ
The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period: A Randomized Control Study

Details for clinical trial NCT03893084

Clinical trial NCT03893084 - References