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The Effectiveness of self-care package on glycemic control and self efficacy in pregnant diabetic Women

Assessment of effectiveness of self-care package in pregnant diabetic women

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015102824753N1
Enrollment
280
Registered
2016-01-09
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Diabetes. Pre-existing diabetes mellitus, insulin-dependent, Pre-existing diabetes mellitus, non-insulin-dependent, Diabetes mellitus arising in pregnancy

Interventions

Intervention 1: Intervention group will be trained based on an approved schedule and curriculum which is the result of a qualitative study with nominal group. Intervention can be as follows: education
Behavior
Intervention group will be trained based on an approved schedule and curriculum which is the result of a qualitative study with nominal group. Intervention can be as follows: educational program is de
The Control group will be received routine care of Clinic.

Sponsors

Vice chancellor for research, Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to 49 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: being pregnant; having diabetes (gestational or overt) confirmed by reliable tests according to the Health Ministry guideline; being able to read and write in Persian; being able to answer the questionnaire independently and sign the consent letter; having no visual or hearing impairment or mental illnesses which needs medication or psychiatrist continuous care; and having no previous experience of participation in any diabetes self care training programs; not being addicted to alcohol; cigarette or drugs; gestational diabetes has been diagnosed not more than a month; gestational age should not be more than 28 weeks; the patient should not experience any intensive stressful events during the study. Exclusion criteria: refusing from cooperation in the study; being absent for two or more educational sessions; occurrence of high-risk pregnancy complications such as vaginal bleeding; preeclampsia; preterm labor; admission in hospital due to any reason; multiple pregnancy; the patient should not be a member of medical and paramedical staff.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Self-efficacy. Timepoint: baseline (pre-intervention) and one month after intervention. Method of measurement: by use of self-efficacy questionare of Stanford University.;Blood sugar. Timepoint: baseline (pre-intervention) and one month after intervention. Method of measurement: level of fast blood sugar,and 2 hour post prandial.

Secondary

MeasureTime frame
Maternal and neonatal results. Timepoint: in and after delivery. Method of measurement: Determining Apgar score, neonatal birth weight, method of delivery and neonatal admission.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMitra Kolivand

Shahroud University of Medical Sciences

mkolivand@shmu.ac.ir; mitrakolivand@kums.ac.ir; mitrakolivand@gmail.com+98 232332394063

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026