Plain English Summary
Background and study aims
During pregnancy, babies often twist and turn. By the time labour begins, most babies settle into a position that allows them to be born headfirst through the birth canal. That doesn't always happen, though. If the baby is lying feet first with their bottom downwards, they are in the breech position. This makes care more complicated. Patients are usually offered the option of an external cephalic version (ECV). This is when an obstetrician tries to turn the baby into a head-down position by applying pressure on the mother’s abdomen. The aim of this study is to test whether applying talcum powder or gel to the mother’s abdomen improves the success rate of ECV.
Who can participate?
Women from 36 weeks of pregnancy onwards with a baby in the breech position who are about to undergo ECV
What does the study involve?
Participants are randomly allocated to have either talcum powder or gel applied during ECV. ECV is performed in the standard way and participants receive standard antenatal care. The success rate of ECV and participants’ satisfaction with the procedure are measured. If ECV fails and the baby stays in the breech position, then the participant undergoes Caesarean delivery at 38–39 weeks of pregnancy.
What are the possible benefits and risks of participating?
The results of this study will help guide the choice of lubricant for ECV. There are no possible risks for the patient on participating in this study.
Where is the study run from?
University Malaya Medical Centre (UMMC) (Malaysia)
When is the study starting and how long is it expected to run for?
January 2011 to December 2012
Who is funding the study?
University Malaya (Malaysia)
Who is the main contact?
1. Dr Vallikkannu Narayanan
2. Prof. Tan Peng Chiong
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC Ref: No: 818.5
Study information
Scientific title
Powder vs gel for external cephalic version: a randomised trial
Acronym
Study hypothesis
Is abdominal application of talcum powder better than aqueous gel for external cephalic
version.
Ethics approval
Medical Ethics Committee University Malaya Medical Centre, 20/10/2010, ref: 818.5
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Clinical obstetrics: in the management of breech presentations
Intervention
Abdominal application of talcum powder versus aqueous gel to aid in performing external cephalic
version
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Current primary outcome measures as of 03/01/2013:
1. Procedure satisfaction score by Visual Numerical Rating Scale (VNRS)
2. Success rate of external cephalic version
Previous primary outcome measures until 03/01/2013:
1. Procedure pain score by Visual Numerical Rating Scale (VNRS)
2. Success rate of external cephalic version
Secondary outcome measures
1. Provider's satisfaction with powder or gel using VNRS.
2. Post ECV CTG anomalies
3. Cephalic presentation at Birth
4. Caesarean delivery rate
5. Neonatal Outcome (SCN admission, Apgar score, cord pH)
6. Mode of delivery
Overall trial start date
01/01/2011
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women from 36 weeks and beyond about to undergo external cephalic version
2. Viable Singleton with breech presentation
3. Gestation ≥ 36 weeks ( check for early confirmation of Gestational Age)
4. Intact membranes
5. Not in established labour ( contractions and cervix ≤ 3cm dilated)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Known gross fetal anomaly
2. Severe hypertension ( ≥ 160/110 mmHg or confirmed per-eclampsia)
3. IUGR ( EFW < 2 kg or US AC < 10th centile on our chart)
4. Oligohydramnios ( AFI <5)
5. Antepartum haemorrhage within last seven days.
6. Uterine scar from any source
7. Known Allergy to powder or gel
8. Other potential obstetric indication for caesarean delivery
8.1. Placenta praevia
8.2. Suspected macrosomia >4 kg
8.3. Uterine anomaly (small fibroids not causing obstruction are acceptable)
8.4. Obstructive pelvic tumour
Recruitment start date
01/01/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Malaysia
Trial participating centre
University Malaya
Klang
41100
Malaysia
Sponsor information
Organisation
University Malaya (Malaysia)
Sponsor details
Institut Pengurusan dan Pemantauan Penyelidikan
Blok C
Aras 3
Bangunan Institut Pengajian Siswazah (IPS)
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Malaya (Malaysia) ref: RG370/11 HTM
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24468078
Publication citations
-
Results
Vallikkannu N, Nadzratulaiman WN, Omar SZ, Si Lay K, Tan PC, Talcum powder or aqueous gel to aid external cephalic version: a randomised controlled trial., BMC Pregnancy Childbirth, 2014, 14, 49, doi: 10.1186/1471-2393-14-49.