Third Trimester Modified Biophysical Profile Scan for Predicting Fetal Outcome.
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|ClinicalTrials.gov Identifier: NCT03729089|
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : April 4, 2019
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.
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
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Death Third Trimester Modified Biophysical Profile Scan||Other: Modified Biophysical Profile scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible pregnant women at 34 to 40 weeks gestation will be randomized to interventional group (Biophysical profile scanning) or to a control group receiving the current standard of care|
|Masking:||None (Open Label)|
|Official Title:||Predicting Fetal Outcome Using Third Trimester Modified Biophysical Profile Scan Compared to Standard of Care; an Open Label Randomized Controlled Trial at St. Francis Hospital Nsambya.|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 29, 2019|
Experimental: Modified Biophysical Profile scan
Participants randomized to intervention group (modified biophysical profile scanning) will receive scans starting from 34 weeks at enrollment then every 3 weeks thereafter until 40 weeks of amenorrhea.
Other: Modified Biophysical Profile scan
Modified biophysical profile scan to be done in third trimester for eligible pregnant mothers
No Intervention: Current standard of care
The participants randomized to this control group will receive the current standard of care recommended by World Health Organization implemented by the attending Doctor. they may receive the modified biophysical profile scanning or not but at non specified time during their pregnancy.
- Perinatal death [ Time Frame: At delivery of the newborn ]Reduction in the proportion of perinatal death will be measured for the two arms of the study to ascertain whether modified biophysical profile can predict perinatal mortality. Perinatal mortality will be measured as death of the new born within the first 7 days of life. The gestational age considered is after 28 weeks of amenorrhea consistent with the health system capacity of the host country and the study hospital
- APGAR score [ Time Frame: at birth ]The APGAR score is a clinical score used to assess well being of all newborns. The clinical features of newborn colour, Respiration, Heart rate, muscle tone and reflex stability depends on the aetiology, intensity and duration of oxygen lack, plasma carbondioxide excess and subsequent acidosis. The score will be taken at 1 minute and at 5 minutes after birth and documented in the case report form. Minimum score is 0/10 while the maximum is 10/10. A score of less than 3/10 at 5 minutes indicates severe birth asphyxia; a score of 4/10 to 6/10 signifies moderate asphyxia and 7/10 to 10/10 is a normal new born. The higher the score, the better the neonatal outcome.
- Neonatal intensive care unit (NICU) admission [ Time Frame: Immediately after birth ]The neonatal intensive care (NICU) admission of the newborn will be documented as yes or no at birth. This will be assessed by documenting the post delivery decision of the attending health worker on whether the baby needs NICU admission or not
- Cesarean section due to fetal condition [ Time Frame: At delivery ]Cesarean section (C/S) performed for fetal conditions will be assessed by the study team by looking out for the indication of C/S and document if it was done due to fetal conditions like non reassuring fetal status, meconium stained liquor, severe oligohydramnios, cord accidents and abnormal fetal heart pattern.
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): NCT03729089
|St. Francis Hospital Nsambya|
|Kampala, Uganda, +256|
|Principal Investigator:||Andrew Odur, MBChB, DPPM||St. Francis Hospital Nsambya|
|Study Chair:||Romano Byaruhanga, MMed, PhD||St. Francis Hospital Nsambya|
|Study Chair:||Rita Nassanga, MMed||St. Francis Hospital Nsambya|
|Study Chair:||Gilbert Tumwine, MMed, MPH||St. Francis Hospital Nsambya|