Home » Trials » SLCTR/2020/017
Efficacy of education about labour process in changing clinical birth outcomes
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SLCTR Registration Number
SLCTR/2020/017
Date of Registration
The date of last modification
Sep 10, 2020
Scientific Title of Trial
Efficacy of education about labour process in changing clinical birth outcomes
Public Title of Trial
A non-randomized controlled trial on the efficacy of an education program on mode of delivery and pregnancy outcomes
Disease or Health Condition(s) Studied
pregnancy
Scientific Acronym
None
Public Acronym
None
Brief title
Efficacy of an education program on the mode of delivery and pregnancy outcome
Universal Trial Number
U1111-1245-9677
Any other number(s) assigned to the trial and issuing authority
P/10/02/2020
What is the research question being addressed?
Does an education program delivered to pregnant mothers change the mode of delivery and birth outcomes?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Sequential
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Obstetric ward of the North Colombo teaching hospital, Ragama
Study design Quasi experimental study design.
Intervention: A research assistant will give a short health talk to eligible mothers in a group of 5 to 10, when they come for the growth scan at 36 weeks. The talk will last for around 15 to 20 minutes, and will focus on; 1.An introduction to labour pains 2.The role played by the staff members during the delivery 3.A brief description of what happen from admission to delivery including the purpose and frequency of per vaginal examination 4.What to do while in the ward 5.What to do/ not to do while in the labour room 6. Introduction to positioning during ‘pushing’ During the talk they will be informed that if any abnormality or threat exists to the woman or her baby during the labour process, an emergency LSCS will take place with their consent.
The control group will receive the standard antenatal care provided at the setting of the Medical Officer of Health and at the tertiary care level.
Inclusion criteria
Primigravid females between 20 to 35 years of age attending the antenatal clinic at of 36 weeks of gestation carrying a single live fetus in cephalic presentation
Exclusion criteria
Primary outcome(s)
|
1.
Mode of delivery – 1) Non assisted Vaginal delivary 2) Forceps delivery 3) Vacuum delivery 3) Elective Cesarean 4) Emergency Cesarean |
[ At post partum ward ] |
Secondary outcome(s)
|
1.
1) Onset of labour - spontaneous or induced 2) If induced - Number of prostaglandin doses used 3) Time duration from admission to labour room to delivery - to the nearest hour 4) Were analgesics used during labour - Y/N 5) If yes, type of analgesia - paracetamol/pethidine 6) Was Artificial Rupture of Membrane done - Y/N 7) Was oxytocin used to augment labour -Y/N 8) Apgar score at birth 9) Neonatal resuscitation required at birth - Y/N 10) Premature Baby Unit admission - Y/N 11) Maternal satisfaction on the birthing experience - Using a standard scale |
[ At post partum ward ] |
Target number/sample size
190 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2020-08-10
Anticipated end date
2021-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
PGIM
Status
Approved
Date of Approval
2020-06-09
Approval number
P/10/02/2020
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Kelaniya |
| Institutional Address: | Faculty of Medicine, University of Kelaniya |
| Telephone: | 0112961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
P.L.D. De silva
Registrar in Gyn and Obs
Colombo North Teaching Hospital, Ragama
0112960023
0716836189
plddesilva@gmail.com
Contact Person for Public Queries
Dr. Pradeep De Silva Consultant
Gyneacologist and Obstetrician,
Colombo North Teaching Hospital, Ragama
0112960023
0772449062
madiwela@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
