Home » Trials » SLCTR/2020/017

Efficacy of education about labour process in changing clinical birth outcomes


SLCTR Registration Number


Date of Registration

04 Aug 2020

The date of last modification

Sep 10, 2020

Application Summary

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


Scientific Acronym


Public Acronym


Brief title

Efficacy of an education program on the mode of delivery and pregnancy outcome

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

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


Study design


Non-randomized controlled trial


Masking not used


Standard therapy/practice




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

  • Mothers having any medical disorders complicating pregnancy
  • Mothers carrying fetuses who are small for gestational age (estimated fetal weight(EFW) less than 10th centile) or large for gestational age (EFW more than 90th centile) or with umbilical artery Doppler resistance index above 95th centile or diagnosed with oligohydramniosis (measured as deepest vertical pool less than 2cm )
  • Mothers with placenta previa

Primary outcome(s)


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) 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


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Self funded

Regulatory approvals


State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee, Kelaniya
Institutional Address:Faculty of Medicine, University of Kelaniya
Email: erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

P.L.D. De silva
Registrar in Gyn and Obs
Colombo North Teaching Hospital, Ragama


Contact Person for Public Queries

Dr. Pradeep De Silva Consultant
Gyneacologist and Obstetrician,
Colombo North Teaching Hospital, Ragama


Primary study sponsor/organization

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results