Birth Asphyxia in Uganda: Prevalence, Associated Factors and Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
试验速览
- 阶段
- 3 期
- 入组人数
- 1,108
- 试验地点
- 1
- 主要终点
- Normalization of the fetal heart rate
研究概览
简要总结
Introduction Birth asphyxia is one of leading causes of neonatal mortality in Uganda. It is associated with long term neuro-developmental complications among the babies that survive. Preventive measures for birth asphyxia intrauterine are not clearly understood and thus the need for this study.
The aim of the study is to assess the effect of intrapartum oxygen administration on fetal and early neonatal outcomes.
Methods A double-blind randomized clinical trial which will be conducted in Gulu regional referral and Kawempe National referral hospitals in Uganda. A total sample size of 1108 women in labour will be enrolled with 554 participants per group. The intervention will include administration of 10 L/min of 100% oxygen for 15 minutes to women in established labor who have signs of fetal distress with fetal heart rate of less than 120 or above 160 beats per minute. The control group will receive medical air (21% oxygen) using the same criteria. Women and babies will be followed up until 7 days after birth to document the outcomes. Statistical analysis to identify difference in outcomes between the control and intervention groups will be performed.
Ethical considerations Ethical approval and permission was received from relevant research and ethics committees. Informed consent will be sought from the participants. A data and safety monitoring board will be set up to review periodically the progress of the clinical trial study. Participants will be monitored for adverse events and severe adverse events; reporting will be done according to the research and ethics committee guidelines.
详细描述
Background:
Foetal distress which refers to fetal heart rate of less than 120 or more than 160 beats per minute(Pildner von Steinburg et al., 2013) during labour is one of the contributing factors to poor newborn outcomes. A proportion of these newborns will require interventions after birth such as resuscitation, oxygen therapy, antibiotics and prolonged hospital admissions. According to a retrospective study in Nigeria, 23% of foetuses diagnosed with fetal distress were born with asphyxia which is a major cause of newborn deaths(Adanikin & Awoleke, 2017). Several interventions to optimise fetal wellbeing as preparations for birth are being instituted have been suggested. These include amnio-infusion, maternal positioning, tocolysis, oxygen administration and intravenous fluid bolus(Bullens, van Runnard Heimel, van der Hout-van, & Oei, 2015; Simpson, 2007). Reviews of intrauterine resuscitation techniques have reported sufficient evidence for use of tocolysis and maternal repositioning to improve fetal pH and Apgar scores(Bullens et al., 2015; Velayudhareddy & Kirankumar, 2010). Although oxygen is used in several settings for intrauterine resuscitation(Dawood & Al-Arnous, 2002; Siriussawakul et al., 2014), its effect when used in labour for management of foetal distress remains debatable. In a Cochrane review to evaluate efficacy of oxygen administration in preventing fetal distress, only two clinical trials were found. There was evidence that the fetal arterial partial pressures of oxygen were improved by oxygen administration although there was a negative effect on pH levels. There is insufficient evidence to recommend or disprove use of oxygen for intrauterine resuscitation(Fawole & Hofmeyr, 2012). This therefore creates sufficient equipoise to undertake this study. In low resource setting where pregnant women are most likely to have anaemia, suffer from malaria and other infections, the role of oxygen for intrauterine resuscitation needs to be explored.
Aim: This study will assess the effect of administration of oxygen to women with fetal distress in the first stage of labour on fetal and early neonatal outcomes in a low resource setting.
Hypothesis: Administering 100% oxygen for 15 minutes to women with fetal distress will reduce the rate of fetal distress by 30% in the first stage of labour.
Study design: A randomised clinical trial with parallel assignment will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Similar gas tanks will be used for both the intervention and control group
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in active first stage of labor who develop fetal distress will be included
排除标准
- •Women in labor with critical conditions such as eclampsia, chronic heart disease, chronic lung disease and chronic renal failure
- •Women in preterm labor
- •Those taking Bleomycin and Amiodarone medications
研究组 & 干预措施
Intervention
This arm will receive 100% oxygen at a rate of 10L/min for 15 minutes
干预措施: 100% Oxygen (Drug)
Control
This arm will receive medical air (21% oxygen) at a rate of 10 L/min for 15 minutes
干预措施: 21% oxygen (Drug)
结局指标
主要结局
Normalization of the fetal heart rate
时间窗: 30 minutes
The fetal heart rate will be between 120 to 160 beats per minute
次要结局
- Birth Asphyxia(At 5 minutes after birth)
- Hypoxic Ischemic encephalopathy(24 hours and 7 days after birth)
- Neonatal Acidosis(Within 5 minutes of birth)
- Status of newborn(7 days after birth)