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Third Trimester Modified Biophysical Profile Scan for Predicting Fetal Outcome.

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.
 
ClinicalTrials.gov Identifier: NCT03729089
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Uganda Martyrs University, St. Francis Hospital Nsambya, Jerusalem IHS and Andrew Abaasa (Study statistician)
Information provided by (Responsible Party):
Dr Andrew Odur, St. Francis Hospital Nsambya

Brief 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


Condition or disease Intervention/treatment Phase
Perinatal Death Third Trimester Modified Biophysical Profile Scan Other: Modified Biophysical Profile scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Viable singleton pregnancy
  • Gestational age between 34 to 40 weeks based on reliable date of onset of last normal menstrual period or earliest dating by ultrasonography.
  • Willing to be followed up

Exclusion Criteria:

  • Mother with diagnosed fetal malformations
  • High-risk pregnancies (Hypertensive disorders of pregnancy, Diabetes mellitus, multiple pregnancies, Sickle cell disease, Heart disease).
  • Inability to consent (e.g. psychiatric conditions or very ill requiring hospitalization).
  • Intrauterine fetal death in the current pregnancy
  • Presently ill with a medical condition requiring admission to hospital

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): NCT03729089


Locations
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Uganda
St. Francis Hospital Nsambya
Kampala, Uganda, +256
Sponsors and Collaborators
Dr Andrew Odur
Uganda Martyrs University, St. Francis Hospital Nsambya, Jerusalem IHS and Andrew Abaasa (Study statistician)
Investigators
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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

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Responsible Party: Dr Andrew Odur, Resident (MMED) in Obstetrics and Gynecology, St. Francis Hospital Nsambya
ClinicalTrials.gov Identifier: NCT03729089    
Other Study ID Numbers: BPP-NSA-001
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only data necessary for publication will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year after publication
Access Criteria: Data will be accessed for now on request from the Principle investigator and shared through email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Perinatal Death
Pregnancy Complications
Death
Pathologic Processes