NCT04525430

Brief Summary

The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

August 9, 2020

Last Update Submit

January 9, 2022

Conditions

Pregnancy RelatedSelf Efficacy

Keywords

pregnancychildbirth educationbirth planself efficacymidwifery

Outcome Measures

Primary Outcomes (1)

  • Change in birth self-efficacy level at 2 weeks (after intervention).

    Childbirth Self-Efficacy was measured with Childbirth Self-Efficacy Inventory (CBSEI) Short Version. The scale consisted of two sub-dimensions, self-efficacy expectancy and outcome expectancy. The highest score to be taken from the sub-dimensions was 160, and the lowest score was 16. Pregnant women's having a high score on this scale meant that the level of their childbirth self-efficacy was high.

    CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.

Study Arms (3)

Group 1

EXPERIMENTAL

only childbirth education group

Other: childbirth education

Group 2

EXPERIMENTAL

childbirth education and was subjected to a birth plan group

Other: childbirth education and was subjected to a birth plan

Group 3

NO INTERVENTION

standard care group

Interventions

childbirth educationOTHER

The 1st Session: General information about labor: Factors affecting labor, early signs of labor, signs of the start of labor, steps of labor, and procedures applied during labor. The 2nd Session: Methods of coping with birth contractions: Breathing exercises, relaxation exercises, massage, changing position, music, cold/warm application, focus, and walking.

Also known as: group-ED
Group 1
childbirth education and was subjected to a birth planOTHER

In the birth plan created by the researchers, the pregnant women considered the process from the start of labor to the end of labor and marked the expectation from and preferences about this process on the birth plan.

Also known as: Group-ED&P
Group 2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women who was in the third trimester (28-40 gestational weeks),
  • who was literate or had a relative/helper who would write a birth plan to be prepared,
  • who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy)
  • who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation).

You may not qualify if:

  • who had previous cesarean section were not included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnönü University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • Aragon M, Chhoa E, Dayan R, Kluftinger A, Lohn Z, Buhler K. Perspectives of expectant women and health care providers on birth plans. J Obstet Gynaecol Can. 2013 Nov;35(11):979-985. doi: 10.1016/S1701-2163(15)30785-4.

    PMID: 24246397RESULT

Related Links

MeSH Terms

Interventions

Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • zeliha sunay, Msc

    munzur üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 25, 2020

Study Start

April 1, 2017

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

we don't share individual participant data with other researchers

Locations

TU(1)