Abdominal application of talcum powder or aqueous gel to aid external cephalic version

ISRCTN	ISRCTN87231556
DOI	https://doi.org/10.1186/ISRCTN87231556
Protocol serial number	MEC Ref: No: 818.5
Sponsor	University Malaya (Malaysia)
Funder	University Malaya (Malaysia) ref: RG370/11 HTM

Submission date: 23/11/2012
Registration date: 11/12/2012
Last edited: 13/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Vallikkannu Narayanan
Scientific

University Malaya
34, Lorong Pokok Sakat
41100, Klang
Selangor
Klang
41100
Malaysia

Study information

Primary study design	Interventional
Study design	Randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Powder vs gel for external cephalic version: a randomised trial
Study objectives	Is abdominal application of talcum powder better than aqueous gel for external cephalic version.
Ethics approval(s)	Medical Ethics Committee University Malaya Medical Centre, 20/10/2010, ref: 818.5
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key 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)
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	01/12/2012

Locations

Countries of recruitment

Malaysia

Study participating centre

University Malaya

Klang
41100
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/01/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/09/2016: Plain English summary added.