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Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204139
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Johannesburg
  Purpose
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.

Condition Intervention Phase
Fetal Congenital Abnormalities Prolonged Pregnancy Multiple Pregnancy Procedure: Routine midtrimester pregnany ultrasound scan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Johannesburg:

Primary Outcome Measures:
  • Detection of congenital abnormalities
  • Postterm pregnancy inductions

Secondary Outcome Measures:
  • Detection of multiple pregnancies
  • Stillbirths
  • Neonatal morbidity
  • Neonatal mortality

Estimated Enrollment: 900
Study Start Date: June 2002
Estimated Study Completion Date: May 2004
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 ultrasound,detection of multiple pregnancy, detection of congenital abnormalities, postterm pregnancy induction, still birth,and neonatal morbidity and mortality.

Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done, using standard statistical methods.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnancy, 24 weeks pregnant or less, willing to participate

Exclusion Criteria:

  • High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204139


Locations
South Africa
University of Johannesburg
Johannesburg, Gauteng, South Africa, 2000
Sponsors and Collaborators
University of Johannesburg
Investigators
Study Chair: Eckhart J Buchmann, MBBCh University of the Witwatersrand, Johannesburg
  More Information

ClinicalTrials.gov Identifier: NCT00204139     History of Changes
Other Study ID Numbers: BvanDyk USS
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2004

Additional relevant MeSH terms:
Congenital Abnormalities
Pregnancy, Prolonged
Pregnancy Complications