ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000994280

Ethics application status

Approved

Date submitted

23/10/2009

Date registered

17/11/2009

Date last updated

9/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Assessment of the effect of social support in labour : a randomised controlled trial

Scientific title

Assessment of the effect of psycho-social support in labour on caesarean section rate: a randomised controlled trial

Universal Trial Number (UTN)

Trial acronym

nil

Linked study record

Health condition

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

Effect of social support on childbirth

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The woman during labour and childbirth is allowed to bring a support person in to the suite after randomisation.
The support person (companion) offer
emotional support
Spiritual support - praying
Massaging
words of encouragement
reassurance

Intervention code [1]

Treatment: Other

Comparator / control treatment

Routine treatment during labour and childbirth is offered to the woman in labour without the presence of companion

Control group

Active

Outcomes

Primary outcome [1]

Caesarean section rate: The Caesarean section rate was compared among women that participated in the trial. The information was obtained from the medical records of the patients in each arm of the study into a proforma immediately after childbirth.

Timepoint [1]

10 percentage points in caesarean section rate between the groups at 80% power. The occurrence of caesarean section is assessed immediately after childbirth

Secondary outcome [1]

Duration of active phase was recorded for each patient immediately after childbirth into a proforma designed for the study by the research assistants

Timepoint [1]

This outcome recorded immediately after childbirth in hours

Eligibility

Key inclusion criteria

Women with anticipated vaginal delivery were enrolled between 30 to 32weeks gestation

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

women with contraindication to vaginal delivery; previous caesarean; intrauterine fetal death; planned induction; multiple pregnancy; malpresentation; and chronic medical disorders. In addition, those with cervical dilatation of >6cm in labour

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Women with anticipated vaginal delivery were enrolled between 30 to 32weeks gestation after informing them in detail about the study during antenatal clinic. After, they were assured that their participation is entirely voluntary and an individual written consent was then obtained. The consented women were allocated into either experimental or control using a randomisation sequence. Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper, put into sealed opaque envelopes before they were given to study participants. Each opaque envelope had a serial number on it. Those in the experimental group were informed to bring someone of their choice to act as a companion during labour. The experimental group consisted of women that received routine care and social support while the controls received only routine care. Each study participant was monitored for clinical outcomes from the onset of established labour till two hours after childbirth.

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

The randomisation sequence was generated using a table of random numbers. Random permuted blocks were used to ensure a balanced design. The blocks are the possible permutations of a sequence of four allocations - two women each belonging to the experimental and control groups. There are 6 possible arrangements of this sequence (ABAB, ABBA, BABA, BBAA, BAAB, AABB) - where A and B represent the groups. On the table, numbers 1 to 6 were assigned to each arrangement and those outside this range were excluded. Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it.

Two trained research assistants (RAs) non-medical staff, supervised the randomisation procedure at every ANC. On each clinic day, consented women that met the inclusion criteria were given serial numbers with allotted treatment group based on their arrival time. Only the statistician and RAs had access to the list of numbers used to prevent clinicians’ influence on the randomisation.. Each subject opens the opaque envelope in the presence of the RAs, and the assigned treatment group was recorded on the woman’s medical record file.. The research protocol was closely monitored by the RAs to avoid bias and also, to ensure that all subjects were assigned to treatment groups.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/11/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

632

Accrual to date

Final

Recruitment outside Australia

Country [1]

Nigeria

State/province [1]

Oyo state

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Gates Institute, Bloomberg School of Public Health Johns Hopkins University through the Centre for Population and Reproductive Health, College of Medicine University of Ibadan, Nigeria

Address [1]

Bloomberg School of Public Health,
Johns Hopkins University,
615N Wolfe Street, Suite E1002,
Baltimore, Maryland 21205,
USA

Country [1]

United States of America

Primary sponsor type

University

Name

Centre for Population and Reproductive Health

Address

College of Medicine,
University of Ibadan, Ibadan, Oyo State

Country

Nigeria

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Ibadan/University College Hospital,institutional review committee

Ethics committee address [1]

College of Medicine,
University of Ibadan, Ibadan, Oyo State

Ethics committee country [1]

Nigeria

Date submitted for ethics approval [1]

04/08/2006

Approval date [1]

16/01/2007

Ethics approval number [1]

UI/IRC/06/0097

Summary

Brief summary

Offering social support during childbirth is not practiced in most Nigerian health facilities despite lots of benefits that have been reported elsewhere. This support service involves staying be side women in labour by either her immediate relations – husbands, sisters or mother, or trained person (doula). The support person (companion) offers words of encouragements, pray, massage the back or hands, and also assist the woman in labour to express her views/concerns to the health care providers. The reported benefit includes shorter duration of labour; reduce risk of delivering by caesarean section, better satisfying labour experience and earlier time to initiate breastfeeding. This has made many hospitals in developed countries to adopt this policy in their maternity care despite availability of adequate method of pain relief during labour and childbirth. 
In Nigeria, women mostly delivered either at home or in mission houses where there labour is supervised by unskilled birth attendants. The policy at most Nigerian health facilities do not permit family members or trained support persons to be by the side of a woman in labour. In addition, pain relief practice is not optimally offered as there is no facility (manpower and equipment) for epidural analgesia.
The study explored the possibility of reproducing the benefits of social support in our settings and also seeks to determine whether it could be promoted as a potential strategy to reducing caesarean section rate as a primary outcome. The secondary outcomes measured were duration of active phase of labour, need for pain relief during childbirth, and experience during childbirth.

Trial website

Trial related presentations / publications

Morhason-Bello IO, Adedokun BO, Ojengbede AO, Olayemi O, Fabamwo AO, Oladokun A. Assessment of the effect of psycho-social support during childbirth in Ibadan, south-west Nigeria: a randomised controlled trial. The Australian and New Zealand Journal of Obstetrics and Gynaecology 2009;49: 145 – 150

Morhason-Bello IO Adedokun BO, Ojengbede OA. Social support as a catalyst for breastfeeding initiation for time Nigerian mothers. International Breastfeeding Journal. In press

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Imran O. Morhason-Bello

Address

Department of Obstetrics and Gynaecology
University College Hospital,
Ibadan,
Oyo State

Country

Nigeria

Phone

+2348034784402

Fax

onembello@yahoo.co.uk

Contact person for scientific queries

Name

Imran O. Morhason-Bello

Address

Department of Obstetrics and Gynaecology
University College Hospital,
Ibadan
Oyo State

Country

Nigeria

Phone

+2348034784402

Fax

onembello@yahoo.co.uk

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

Source	Title	Year of Publication	DOI
Dimensions AI	Social support during childbirth as a catalyst for early breastfeeding initiation for first-time Nigerian mothers	2009	https://doi.org/10.1186/1746-4358-4-16

N.B. These documents automatically identified may not have been verified by the study sponsor.

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