NCT02929875

Brief Summary

In an experimental research, 100 nulliparous pregnant women who had referred to health care centers in Kermanshah were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. instruction based on TPB was provided just for the case group. Afterwards, post-test was taken by both groups and the results were analyzed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 8, 2016

Last Update Submit

October 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of child birth by Vaginal/Natural Delivery method.

    such data are registered officially in hospitals and health centers. we collect the data through seeing the documents

    3 Months

Study Arms (2)

Case (Educational based on TPB)

EXPERIMENTAL

Educational intervention delivered to subjects. The content of education includes: Three training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions.

Behavioral: Education based on TPB

Control (No intervention)

NO INTERVENTION

No educational intervention provided to subjects in control group

Interventions

Three Training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions.

Case (Educational based on TPB)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, informed consent of the mother and her husband, and no contraindications for normal childbirth.

You may not qualify if:

  • Included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic member

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 11, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share