NCT01936610

Brief Summary

In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week were selected using multi-stage sampling and assigned into two groups randomly. Decision-making (before, two weeks after and at admission in maternity department) was tested by a researcher -made questionnaire. In experiment group, advantages and disadvantages of normal delivery and cesarean-section delivery were presented by role-playing in three 90-min scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean difference test, exact fisher test, independent t-test and paired t-test.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for phase_2 pregnancy

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2 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

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
Last Updated

September 6, 2013

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

September 3, 2013

Last Update Submit

September 5, 2013

Conditions

Keywords

LectureRole-playingKnowledgeAttitudeDecision makingType of delivery

Outcome Measures

Primary Outcomes (1)

  • Decision making

    Two weeks after educational course for each group (Lecture and Role play), knowledge, attitude and decision making questionnaire were completed again. They were followed at admission by phone conversation for knowing their decision.

    2 weeks

Study Arms (2)

role play

EXPERIMENTAL

In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section .

Other: role play

lecture

EXPERIMENTAL

describe the advantages and disadvantages of normal delivery and cesarian section

Other: lecture

Interventions

In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section.

role play
lectureOTHER

Describe advantages and disadvantages in one 90-min session

lecture

Eligibility Criteria

Age20 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primipara , single pregnancy , gestational age of 34-36 weeks ,age of 18-35 years old, no history of infertility, no indication for cesarean section, no passing educational course for delivery methods

You may not qualify if:

  • medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Midwifery

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

September 6, 2013

Record last verified: 2010-05