|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Abdominal application of Talcum Powder or aqueous gel to aid external cephalic version. |
| ISRCTN | ISRCTN87231556 |
| DOI | 10.1186/ISRCTN87231556 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Abdominal application of Talcum Powder or aqueous gel to aid external cephalic version. |
| Scientific title | Powder vs Gel for external cephalic version: a randomised trial |
| Acronym | N/A |
| Serial number at source | MEC Ref: No: 818.5 |
| Study hypothesis |
Is abdominal application of talcum powder better than aqueous gel for external cephalic
version. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Medical Ethics Committee University Malaya Medical Centre, 20 October 2010, ref: 818.5 |
| Study design | Randomised trial |
| Countries of recruitment | Malaysia |
| Disease/condition/study domain | Clinical Obstetrics: In the management of Breech presentations. |
| Participants - 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) |
| Participants - 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 >4kg 8.3. Uterine anomaly ( small fibroids not causing obstruction are acceptable) 8.4. Obstructive pelvic tumour |
| Anticipated start date | 01/01/2011 |
| Anticipated end date | 01/12/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
Abdominal application of talcum powder versus aqueous gel to aid in performing external cephalic
version |
| 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 |
| 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 |
| Sources of funding | University Malaya (Malaysia) ref: RG370/11 HTM |
| Trial website | |
| Publications | |
| Contact name | Dr Vallikkannu Narayanan |
| Address |
University Malaya
34, Lorong Pokok Sakat 41100, Klang, Selangor |
| City/town | Klang |
| Zip/Postcode | 41100 |
| Country | Malaysia |
| Sponsor | University Malaya (Malaysia) |
| Address |
Institut Pengurusan dan Pemantauan Penyelidikan
Blok C, Aras 3, Bangunan Institut Pengajian Siswazah (IPS) |
| City/town | Kuala Lumpur |
| Zip/Postcode | 50603 |
| Country | Malaysia |
| Sponsor website: | http://www.ippp.um.edu.my |
| Date applied | 23/11/2012 |
| Last edited | 03/01/2013 |
| Date ISRCTN assigned | 11/12/2012 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
