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Third Trimester Modified Biophysical Profile Scan for Predicting Fetal Outcome.

NCT03729089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-04-04

No results posted yet for this study

Summary

Study topic:

Predicting fetal outcome using third trimester modified biophysical profile (BPP) scan compared with standard of care; a randomized clinical trial at St. Francis Hospital, Nsambya.

This is an open label randomized clinical trial comparing the third trimester modified biophysical profile done between 34 to 40 weeks with the current standard of care in reducing perinatal mortality at St. Francis Hospital, Nsambya

Objectives of the study:

Broad study objectives:

To evaluate the role of third trimester modified biophysical profile scan in predicting fetal outcome among pregnant mothers at St. Francis Hospital, Nsambya.

Specific study objectives:

* To determine the percentage decline in perinatal mortality following use of third trimester biophysical profile from 34 to 40 weeks at St. Francis Hospital, Nsambya.
* To determine if use of third trimester BPP scan improves prediction of perinatal outcome more than the current standard of care at St. Francis Hospital, Nsambya.
* To determine the fetal outcome of pregnancies done modified BPP and those who received current standard of care at St. Francis Hospital, Nsambya.

Hypothesis:

The hypothesis of the study is that performing third trimester modified biophysical profile scan between 34 and 40 weeks compared to standard of care is associated with a 16 percent reduction

Conditions

  • Perinatal Death
  • Third Trimester Modified Biophysical Profile Scan

Interventions

OTHER

Modified Biophysical Profile scan

Modified biophysical profile scan to be done in third trimester for eligible pregnant mothers

Sponsors & Collaborators

  • Uganda Martyrs University, St. Francis Hospital Nsambya, Jerusalem IHS and Andrew Abaasa (Study statistician)

    collaborator UNKNOWN

  • Dr Andrew Odur

    lead OTHER

Principal Investigators

  • Andrew Odur, MBChB, DPPM · St. Francis Hospital Nsambya

  • Romano Byaruhanga, MMed, PhD · St. Francis Hospital Nsambya

  • Rita Nassanga, MMed · St. Francis Hospital Nsambya

  • Gilbert Tumwine, MMed, MPH · St. Francis Hospital Nsambya

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-03-01
Completion
2019-03-29

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729089 on ClinicalTrials.gov