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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Perinatal death
研究概览
简要总结
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
详细描述
Randomization:
Eligible participants will be randomly allocated to one of the two study groups (modified biophysical profile scan arm or current standard of care arm) by an independent statistician who will not be involved in data analysis. The independent statistician will generate a randomization register consisting of the sequential study numbers but without the allocated study group. The register will be held at the enrollment clinic and patients who will be eligible for enrollment will be assigned the next available number on the register until the required sample size is reached. The principal investigator will identify a secure room from where opaque envelopes containing the different study arms will be kept. Participants will pick envelopes randomly from the pool of envelopes to obtain the study arm to which they automatically belong.
Blinding:
The study will be open label but only blinding the allocation at study entry.
Randomization concealment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Modified Biophysical Profile scan (Other)
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.
结局指标
主要结局
Perinatal death
时间窗: 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
次要结局
- Neonatal intensive care unit (NICU) admission(Immediately after birth)
- Cesarean section due to fetal condition(At delivery)
- APGAR score(at birth)
研究者
Dr Andrew Odur
Resident (MMED) in Obstetrics and Gynecology
St. Francis Hospital Nsambya