Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings: A Randomized Pilot Feasibility Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- Percentage of perinatal mortality
研究概览
简要总结
The goal of this feasibility pilot clinical trial is to determine if sildenafil citrate 50mg orally, up to three times during labor, can: 1) reduce perinatal mortality and/or bag and mask ventilation at birth in planned vaginal delivery and 2) reduce the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress in up to four facilities of different levels of care in low-resource countries.
The main questions it aims to answer are:
Does sildenafil citrate decrease:
- the incidence of operative delivery (instrumental vaginal birth or emergency cesarean section) for presumed or suspected fetal distress?
- the incidence of bag and mask ventilation?
- the incidence of perinatal mortality?
Researchers will compare sildenafil citrate to a placebo (a look-alike substance that contains no drug) to see if sildenafil works to prevent fetal distress necessitating operative delivery, bag and mask resuscitation at birth, and ultimately, perinatal mortality.
Participants will:
- Take Sildenafil 50 mg or placebo orally every eight hours during labor (up to 3 doses)
- Have the (mothers and babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag & mask ventilation, Apgar Scores, and seizures.
- Have a neonatal neurological assessment prior to discharge
- Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.
详细描述
Pregnant women with planned vaginal deliveries will be screened for eligibility. After informed consent obtained, subjects will be randomly assigned (using computer generated, stratified randomization codes by the pharmacy) to either the treatment arm (Sildenafil citrate) or the placebo concurrent control. Clinicians, researchers, and primary caregivers will be masked. Eligible women will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor. Neither medication no placebo will be given following completion of labor. All additional care of the mother and infant will be provided according to the local standard of care. A neurological examination (Sarnat and Thompson) will be completed on the infant within 24 hours after birth. Neonatal oxygen saturation will be measured by pulse oximetry at 48 hours or discharge, whichever comes first. Outcomes will be collected following delivery, discharge, and 7-days post-partum. 7-day follow-up for outcomes will be obtained via a telephone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator and Outcomes Assessor) The only unmasked person will be the pharmacist who dispenses the study medication--sildenafil 50 mg or identical placebo.
入排标准
- 年龄范围
- 0 Days 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women presenting in early labor with a term pregnancy (≥ 37 weeks to 41wks 6days gestation )
- •Early labor will be defined as cervical dilation less than 7cm
- •Gestational age will be calculated from the most reliable variable using the following hierarchy of reliability: 2) gestational dating ultrasound completed at any time during the pregnancy (with preference to the earliest exam); 2) date of last menstrual period if menses are regular.
- •Planned vaginal delivery and admission to health facility with clear plan for spontaneous or induced vaginal delivery
- •Maternal age ≥ 18yrs
排除标准
- •Unknown gestational age
- •Non-cephalic fetal presentation
- •Plan for cesarean delivery prior to enrollment
- •Previous uterine scar (cesarean section and/or myomectomy)
- •Advanced stage of labor (7 cm or greater cervical dilation per local standards) and pushing, or too distressed to understand, confirm, or give informed consent regardless of cervical dilation
- •Not capable of giving consent due to other health problems, such as obstetric emergencies (i.e. antepartum hemorrhage) or mental disorder
- •Maternal contraindication to sildenafil therapy, such as hypersensitivity to nitrates or nitrites
- •Recognized major structural fetal anomaly
- •Previous randomization in the trial
研究组 & 干预措施
Oral Sildenafil 50mg
Sildenafil citrate 50mg given orally every eight hours up to 3 doses while mother is in labor
干预措施: Sildenafil 50 mg Oral Tablet (Drug)
Placebo
Identical-appearing treatment that does not contain the test drug given orally every eight hours up to 3 doses while mother is in labor
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percentage of perinatal mortality
时间窗: 96 hours after enrollment
Documentation of stillbirth or neonatal death
Percentage of operative delivery
时间窗: 96 hours after enrollment
Documentation of type of delivery
Percentage of use of bag and mask in neonates after delivery
时间窗: 20 minutes after delivery
Documentation of the use of bag and mask ventilation as resuscitation after delivery
Indication for operative delivery
时间窗: 96 hours after enrollment
Documentation of type of delivery
次要结局
- Indication for fetal heart rate monitoring(96 hours after enrollment)
- Percentage of mothers who received fetal heart rate monitoring(96 hours after enrollment)
- Apgar Score(1 minute and 5 minutes after birth)
- Percentage of neonates with neonatal encephalopathy by Sarnat Score(24 hours after birth)
- Percentage of neonates with neonatal encephalopathy by Thompson Score(24 hours after birth)
- Percentage of infants with neonatal hypoxic-ischemic encephalopathy(96 hours after enrollment)
- Percentage of neonates with hypoxemia(48 hours after birth or at discharge, if early discharge)
- Percentage of neonatal ICU admissions(96 hours after enrollment)
- Percentage of maternal rehospitalization(7 days)
- Percentage of neonatal rehospitalization(7 days)
研究者
Waldemar A. Carlo
Edwin M. Dixon Professor of Pediatrics
University of Alabama at Birmingham