Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204139
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting a Cluster Randomised Controlled Trial
Sponsor:
University of Johannesburg
Organization:
University of Johannesburg
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies Few studies have addressed this issue in poorly resourced settings This trial will attempt to determine the benefits if any of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine only selective scanning This will be done by recruiting about 900 women in South Africa and randomly allocating about half to routine scanning and half to selective scanning groups and following up their pregnancies
Detailed Description:
Routine ultrasound scanning in the second trimester of pregnancy has few substantive benefits according to the results of number of randomised trials mostly performed in industrialised countries While ultrasound did not seem to prevent fetal death it was associated with improved detection of multiple pregnancies improved detection of congenital abnormalities and reduced need for postterm labour induction Only one trial from Cape Town has investigated the benefits of a policy of routine second trimester ultrasound scanning in an under-resourced setting
This will be cluster randomised controlled trial performed in the Krugersdorp area of South Africa where most health service users are African working class and dependent on government health facilities About 900 low-risk pregnant women at less than 24 weeks gestation will be recruited and randomised in clusters to either routine scanning or no scanning with recourse to selective scanning if clinically indicated
Women will be followed up for maternal fetal and neonatal outcome and for indices of health service utilisation Important outcome measures will be need for subsequent ultrasounddetection of multiple pregnancy detection of congenital abnormalities postterm pregnancy induction still birthand neonatal morbidity and mortality
Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done using standard statistical methods
This will be cluster randomised controlled trial performed in the Krugersdorp area of South Africa where most health service users are African working class and dependent on government health facilities About 900 low-risk pregnant women at less than 24 weeks gestation will be recruited and randomised in clusters to either routine scanning or no scanning with recourse to selective scanning if clinically indicated
Women will be followed up for maternal fetal and neonatal outcome and for indices of health service utilisation Important outcome measures will be need for subsequent ultrasounddetection of multiple pregnancy detection of congenital abnormalities postterm pregnancy induction still birthand neonatal morbidity and mortality
Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done using standard statistical methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None