Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
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 252052 0
Condition category
Condition code
Reproductive Health and Childbirth 252246 252246 0 0
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] 241450 0
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] 253120 0
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] 253120 0
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] 257991 0
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] 257991 0
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] 2293 0
Nigeria
State/province [1] 2293 0
Oyo state

Funding & Sponsors
Funding source category [1] 243923 0
University
Name [1] 243923 0
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
Country [1] 243923 0
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] 251279 0
None
Name [1] 251279 0
Address [1] 251279 0
Country [1] 251279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244034 0
University of Ibadan/University College Hospital,institutional review committee
Ethics committee address [1] 244034 0
Ethics committee country [1] 244034 0
Nigeria
Date submitted for ethics approval [1] 244034 0
04/08/2006
Approval date [1] 244034 0
16/01/2007
Ethics approval number [1] 244034 0
UI/IRC/06/0097

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30414 0
Address 30414 0
Country 30414 0
Phone 30414 0
Fax 30414 0
Email 30414 0
Contact person for public queries
Name 13661 0
Dr. Imran O. Morhason-Bello
Address 13661 0
Department of Obstetrics and Gynaecology
University College Hospital,
Ibadan,
Oyo State
Country 13661 0
Nigeria
Phone 13661 0
+2348034784402
Fax 13661 0
Email 13661 0
[email protected]
Contact person for scientific queries
Name 4589 0
Imran O. Morhason-Bello
Address 4589 0
Department of Obstetrics and Gynaecology
University College Hospital,
Ibadan
Oyo State
Country 4589 0
Nigeria
Phone 4589 0
+2348034784402
Fax 4589 0
Email 4589 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AISocial support during childbirth as a catalyst for early breastfeeding initiation for first-time Nigerian mothers2009https://doi.org/10.1186/1746-4358-4-16
N.B. These documents automatically identified may not have been verified by the study sponsor.