ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616001545459

Ethics application status

Approved

Date submitted

14/10/2016

Date registered

9/11/2016

Date last updated

9/11/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Skills-based childbirth and coaching preparation: self-efficacy and other psychological birth outcomes for first births.

Scientific title

Skills-based childbirth and coaching preparation: self-efficacy and other psychological birth outcomes for first births.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1188-6956

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

childbirth

mental health

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A skills based interventional package is posted to women, they complete it at home in their own time. The intervention is a anonymised version of "The Pink Kit for Birthing Better". The kit is sent out to women and contains 4 e-books, two audio CDs and a DVD. Women can choose when to read or listen to any of the content from 24 weeks gestation until full term. It is not personalised and participants will be asked what percentage of the course they think they used after the birth of their child.
Contents of the PInk Kit:
4 e-books:
1. Breath, language and
touch skills
2. Teamwork and managing
skills
3. Rationalization for basic
skills applicable for every
birth
4. Extra skills for
specific situations
1 DVD and contents
Skills to manage birth
process, eg:
Directed breathing
Map your pelvis
Teamwork
Skills to keep the body’s structure relaxed and open, for example:
Deep touch relaxation
Cervical relaxation
Hip lift
Sit bone spread
Pelvic clock
Kate’s cat

2 CDs and contents
How to prepare the
birth passage, eg:
internal work
Skills for each phase of a contraction

The second intervention is a collection of birth stories put together by the researchers to act as an active control.

Intervention code [1]

Behaviour

Comparator / control treatment

There are two control groups. Participants randomised to the Active control condition are sent a book of birth stories. These were stories collated by the researchers which represent first person accounts of births, both simple and complicated.
There is also a treatment as usual control group. This group filled in the questionnaires at the same time points but were not given any intervention or provided with any treatment. The intervention provides no treatment, intervention or information for this group.
Both groups continue with their planned childbirth preparation on their own.

Control group

Active

Outcomes

Primary outcome [1]

The Mackey Birth Satisfaction survey will be used to assess whether the intervention group had greater birth satisfaction than the active and TAU control groups. This is a simple ANOVA analysis.

Timepoint [1]

Within two weeks of childbirth

Primary outcome [2]

A comparison of scores on Childbirth self-efficacy scale between groups will be conducted using ANOVA.

Timepoint [2]

At 36 weeks pregnant

Secondary outcome [1]

Post-natal depression is measured using the Edinburgh Post-natal Depression Scale, no cut off is used a between group analysis is conducted.

Timepoint [1]

6 months after childbirth

Secondary outcome [2]

Family Life satisfaction was measured using the self-reported Family Life Satisfaction Scale. Groups are compared.

Timepoint [2]

6 months post-birth

Secondary outcome [3]

Midwives ratings. These were made for the purposes of the study.
Comparative work-related stress was measured on a visual analogue scale (VAS: 0 [much lower level of stress] -100 [much higher level of stress]) in response to the following questions. The questions were:

Comparative work related stress: Please use the following scale to rate how much less stress or how much more stress you experienced when caring for this client/patient and her partner compared to that you usually experience when caring for a client/patient and her partner by putting a stroke through the line.

Complications: Was there any expected physical issue (for example, breech position) or any other unexpected physical issue (only physical) which accounted for the stress you experienced?

Provision was also made for midwives to make comments.

Timepoint [3]

These surveys were posted to midwives after they had stopped caring for the women in the trial ie. at least 6 weeks post-birth.

Eligibility

Key inclusion criteria

Must be pregnant and expecting a first child. Must have a partner. Must be less than 24 weeks pregnant. The partners of women who volunteered for the study were also invited to participate, there were no inclusion/exclusion criteria for partners. Midwives were sent a questionnaire at the conclusion of the study as informants rather than participants

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Unable to speak english or understand questionnaires. No home address.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

none

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size was calculated to be 60 per group.
Quantitaive and qualitative analysis was used. ANOVAs and post-hoc regression analysis.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/08/2011

Date of last participant enrolment

Anticipated

Actual

31/10/2013

Date of last data collection

Anticipated

Actual

31/10/2014

Sample size

Target

180

Accrual to date

Final

182

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO box 56
Dunedin 9016

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56
Dunedin 9016

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern HDEC

Ethics committee address [1]

Ministry of Health, PO Box 5013 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/02/2011

Approval date [1]

17/03/2011

Ethics approval number [1]

LRS/10/11/052

Summary

Brief summary

A randomised controlled trial examined a skills-based self-teach childbirth/childbirth coaching preparation programme. The trial examined whether there was an effect on birth satisfaction, and parenting self-efficacy, family life satisfaction, and postpartum depression at six months postpartum. A post hoc analysis treating data as a prospective observational study sought to determine which covariates were linked to birth satisfaction, and the three six months measures. Comments collected with the post birth questionnaire twere also analysed to deepen our understanding of the birth experience of both parents. Lastly, this research project examined whether the midwife benefited when clients undertook the skills-based preparation.
 A sample of 182 first time mothers and their partners was recruited from throughout New Zealand. Participants completed four questionnaires composed of established survey instruments between 24 weeks gestation and six months postpartum. One hundred and four midwives elected to complete a survey.
 A 3X2 repeated measures ANOVA revealed that the self-taught skills (Intervention) group changed differently over time, reporting a higher increase in childbirth self-efficacy and higher decrease in family life satisfaction for mothers compared to the Active and Passive Control Groups. An ANOVA analysis revealed that mothers and fathers in the Intervention and Active Control Groups reported higher birth satisfaction compared to the Passive Control Group.
A post-hoc regression analysis found there were many significant associations with the outcomes of birth satisfaction, parenting self-efficacy, family life satisfaction and postpartum depression. 
For mothers three major themes emerged from the phenomenological thematic analysis of the data. When she felt she owned her process, had good care/carers and support/supporters, and had a safe delivery, the mother reported higher birth satisfaction. For fathers four major themes emerged. When he felt confident of the safety of mother and baby throughout the process, that he was included and involved, that the mother coped well with childbirth, and that the birth and after met his expectations, the father reported higher birth satisfaction.
An ANCOVA determined that midwives in the Intervention Group experienced less stress than they generally experienced compared to the midwives working with the other two groups.
The skills-based preparation advocated in The Pink Kit Method for was effective in increasing mothers’ childbirth self-efficacy.

Trial website

https://www.facebook.com/FirstTimeBirths/
www.firsttimebith.co.nz

Trial related presentations / publications

none

Public notes

none

Contacts

Principal investigator

Name

Ms Anne Howarth

Address

Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016

Country

New Zealand

Phone

+64 3 470 9451

Fax

anne@theunfocused.net

Contact person for public queries

Name

Nicola Swain

Address

Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016

Country

New Zealand

Phone

+64 3 470 9451

Fax

nicola.swain@otago.ac.nz

Contact person for scientific queries

Name

Nicola Swain

Address

Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016

Country

New Zealand

Phone

+64 3 470 9451

Fax

nicola.swain@otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically