NCT00204139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

July 1, 2004

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Fetal Congenital AbnormalitiesProlonged PregnancyMultiple Pregnancy

Outcome Measures

Primary Outcomes (2)

  • Detection of congenital abnormalities

  • Postterm pregnancy inductions

Secondary Outcomes (4)

  • Detection of multiple pregnancies

  • Stillbirths

  • Neonatal morbidity

  • Neonatal mortality

Interventions

Routine midtrimester pregnany ultrasound scanPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2000, South Africa

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eckhart J Buchmann, MBBCh

    University of the Witwatersrand, Johannesburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2002

Study Completion

May 1, 2004

Last Updated

September 20, 2005

Record last verified: 2004-07

Locations

ZA(1)