Third Trimester Modified Biophysical Profile Scan for Predicting Fetal Outcome.

NCT03729089 | Completed DMC

• 1 other identifier: BPP-NSA-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Conditions

Perinatal Death; Third Trimester Modified Biophysical Profile Scan

Outcome Measures

Primary Outcomes (1)

• Perinatal death

  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

  At delivery of the newborn

Secondary Outcomes (3)

• APGAR score

  at birth

• Neonatal intensive care unit (NICU) admission

  Immediately after birth

• Cesarean section due to fetal condition

  At delivery

Study Arms (2)

Modified Biophysical Profile scan

EXPERIMENTAL

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

Current standard of care

NO INTERVENTION

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.

Interventions

Modified Biophysical Profile scan OTHER

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

Modified Biophysical Profile scan

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Andrew Odur: lead
• Uganda Martyrs University, St. Francis Hospital Nsambya, Jerusalem IHS and Andrew Abaasa (Study statistician): collaborator

Study Sites (1)

St. Francis Hospital Nsambya

Kampala, +256, Uganda

Location

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Odur, MBChB, DPPM

  St. Francis Hospital Nsambya

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident (MMED) in Obstetrics and Gynecology

Model Details: 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

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 29, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

UG (1)