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

ISRCTN ISRCTN87231556
DOI https://doi.org/10.1186/ISRCTN87231556
Secondary identifying numbers MEC Ref: No: 818.5
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

Study designRandomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePowder vs gel for external cephalic version: a randomised trial
Study objectivesIs 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) studiedClinical obstetrics: in the management of breech presentations
InterventionAbdominal application of talcum powder versus aqueous gel to aid in performing external cephalic
version
Intervention typeOther
Primary outcome measureCurrent 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 measures1. 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 study start date01/01/2011
Completion date01/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2011
Date of final enrolment01/12/2012

Locations

Countries of recruitment

  • Malaysia

Study participating centre

University Malaya
Klang
41100
Malaysia

Sponsor information

University Malaya (Malaysia)
University/education

Institut Pengurusan dan Pemantauan Penyelidikan
Blok C, Aras 3, Bangunan Institut Pengajian Siswazah (IPS)
Kuala Lumpur
50603
Malaysia

Website http://www.ippp.um.edu.my
ROR logo "ROR" https://ror.org/00rzspn62

Funders

Funder type

University/education

University Malaya (Malaysia) ref: RG370/11 HTM

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

13/09/2016: Plain English summary added.