Condition category
Pregnancy and Childbirth
Date applied
23/11/2012
Date assigned
11/12/2012
Last edited
13/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Vallikkannu Narayanan

ORCID ID

Contact details

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

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 measures

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

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

http://www.ippp.um.edu.my

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24468078

Publication citations

  1. 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.

Additional files

Editorial Notes

13/09/2016: Plain English summary added.