Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at LAUTECH Teaching Hospital, Ogbomoso, a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Incidence of non-reassuring foetal heart rate patterns
研究概览
简要总结
Background: Intrapartum non-reassuring foetal status is a global challenge. It is a key contributor to operative deliveries. In low- and middle-income countries, it is a major cause of perinatal deaths, hypoxic ischemic encephalopathy, and cerebral palsy. Through its vasodilatory action and by improving uteroplacental perfusion, intrapartum sildenafil citrate could reduce the risk of intrapartum foetal compromise.
Aim: To determine the effect of intrapartum Sildenafil citrate on the prevention of non-reassuring foetal status among parturients delivering at term.
Specific Objectives: 1. To determine the frequency of non reassuring foetal heart rate (FHR) pattern among parturients delivering at term following administration of intrapartum Sildenafil citrate compared with placebo 2. To determine the rate of Caesarean delivery for non-reassuring FHR following the administration of intrapartum Sildenafil citrate compared with placebo. 3. To determine the rate of instrumental delivery for non-reassuring FHR following the administration of intrapartum Sildenafil citrate compared with placebo 4. To determine the effect of Sildenafil citrate on uteroplacental blood flow compared with placebo. 5. To determine if Sildenafil citrate is associated with an improved APGAR score at 5th minute compared with placebo.
Methodology: Study Design: Double blind randomised controlled trial. Women at term in early labour or undergoing scheduled induction of labour will be randomly allocated to receive 50 mg of sildenafil citrate or placebo orally once admitted in labour 6 hourly up to a maximum dose of 150 mg. Intrapartum foetal monitoring will be done by continuous cardiotocogragh, labour will be monitored with the aid of partograph following the departmental protocol for conduct of labour.
Planned Handling of Results: Obtained data will be analyzed using IBM (International Business Machines Corporation) SPSS (Statistical Product and Service Solutions) version 21, taking level of significance as p-value <0.05. Categorical variables will be expressed as percentages and presented using frequency tables and charts. The chi-square test will be used to test for association between categorical variables. Continuous variables will be presented as mean or median. Differences between continuous variables will be compared with the Student t test.
详细描述
Study Area The study will be carried out at LAUTECH Teaching Hospital (LTH), Ogbomoso. LTH Ogbomoso is located in Ogbomoso North Local Government area of Oyo state and most inhabitants are Yoruba speaking. It was officially commissioned in May, 2011. The study will be undertaken in the Obstetrics and Gynaecology Department of LTH Ogbomoso, the delivery rate in the department is about a hundred vaginal deliveries per month, average monthly antenatal clinic attendance of about two hundred and fifteen, an average annual caesarean section rate of 22.2% with foetal distress accounting for 14.0% of the cases was reported by Owonikoko et. al between 2011 and 2013.5
Study Design:
Double-blind, placebo-controlled, superiority randomised controlled trial.
Study Population Participants will be parturients with apparently uncomplicated, low-risk pregnancies, with appropriately grown foetuses, participants will be recruited at term (37-39+6 weeks of gestation). Women with both spontaneous and induced onset of labour will be considered eligible for inclusion. Those undergoing induction of labour will only be considered eligible if the indication for this was postdates pregnancy (before 42 weeks of gestation) or if induction had been planned for social reasons. Women undergoing induction as a result of foetal or maternal complications will not be included.
Recruitment of Participants:
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
The packaging of the trial drugs will be carried out under sterile hygienic condition in the hospital pharmacy department by two of the hospital pharmacists who will be dedicated to the study, they will prepare sequentially ordered packs labelled with individual study identification numbers containing identical tablets of sildenafil citrate or placebo, they will be the only one who know which number is assigned to sildenafil citrate or placebo.
Women, clinicians, and principal investigator will be unaware of allocation. Clinical staff managing the labour will be blinded to the ultrasound results and retained responsibility for all decisions regarding intrapartum care. At LTH Ogbomoso, all decisions for caesarean delivery are made by the obstetrics team under the supervision of consultant Obstetrician.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother aged between 18- 49 years
- •Singleton pregnancy between 37+0 - 39+6 weeks gestation
- •Cephalic presentation
- •Foetus without any known structural, chromosomal or genetic abnormality
- •Planned vaginal delivery
排除标准
- •Women undergoing induction of labour as a result of foetal or maternal complications
- •Women in labour with Cervical dilatation > 8 cm,
- •Ruptured membranes with meconium stained liquor, or evidence of intrauterine infection.
- •Previous caesarean delivery
- •Foetus known to be small for gestational age, or suspected foetal growth restriction
- •Those with a contraindication to sildenafil citrate, such as hypersensitivity to sildenafil citrate, to an ingredient in its formulation, to nitrates or nitrites or to Riociguat.
- •Women with pre-existing heart disorders, stroke, hypotension or hypertension, pre-eclampsia, retinitis pigmentosa, kidney or liver abnormalities, sickle cell anaemia, gastrointestinal bleeding or any other bleeding disorder 40
- •Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), amyl nitrate, nicorandil, nitrates (including glyceryl trinitrate or isosorbide salts), sodium nitroprusside, bosentan, fosamprenavir and ritonavir combination, hepatic enzyme inhibitors CYP3A4 (including itraconazole, ketoconazole, ritonavir, cimetidine, erythromycin, saquinavir, darunavir), hepatic enzyme substrates (CYP3A4 and beta-adrenergic blocking agents), medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
研究组 & 干预措施
Sildenafil citrate arm
The same brand of sildenafil citrate (VIAGRA, manufactured by Fareva Amboise Zone Industrielle, 29 route des Industries, 37530 Poce Sur Cisse, France, under authority of Pfizer Inc, NewYork, NAFDAC Reg NO: 04 - 1509, Batch No: 477209; Exp date: 11 - 2024) will be used in the course of the study.
Women will receive the first dose of trial medication after transfer to the birth suite once diagnosed to be in labour with cervical dilatation < 8 cm. Sildenafil citrate will be given orally as a 50-mg dose 6 hourly to a maximum of 3 doses (150mg). Blood pressure will be monitored 15-30 minutes after each dose. Labour will be monitored with the aid of partograph, appropriate analgesic given in labour. Foetal heart rate monitoring will be performed in all cases by cardiotocograph or intermittent auscultation every fifteen minutes
干预措施: Sildenafil citrate (Drug)
Placebo
The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra).
干预措施: Sildenafil citrate (Drug)
结局指标
主要结局
Incidence of non-reassuring foetal heart rate patterns
时间窗: from admnistration of the drug till the delivery of the baby
A Non-reassuring foetal heart rate pattern will be defined as one or more of the following features;60 Bradycardia, FHR \<110 bpm Tachycardia, FHR \> 160bpm Baseline variability \< 5 bpm for 30 to 50 minutes OR More than 25 bpm for 15 to 25 minutes Absence of acceleration in 20 to 30 minutes tracing Early Deceleration Variable decelerations with no concerning characteristics\* for 90 minutes or more OR Variable decelerations with any concerning characteristics\* in up to 50% of contractions for 30 minutes or more OR Variable decelerations Late decelerations in over 50% of contractions for less than 30 minutes, with no maternal or foetal clinical risk factors such as vaginal bleeding or significant meconium \* Regard the following as concerning characteristics of variable decelerations: lasting more than 60 seconds;
次要结局
- Incidence of fresh meconium-stained liquor(from admnistration of the drug till the delivery of the baby)
- Rate of admission to the Special Care Baby Unit (SCBU)(at delivery)
- Rate of emergency caesarean delivery for non-reassuring foetal status(at delivery)
- Rate of instrumental vaginal birth for non-reassuring foetal status(at delivery)
- Incidence of adverse neonatal outcomes ( APGAR score <7 at 5 minutes)(at delivery)
- Incidence of neonatal encephalopathy (Sarnat stage 2 or 3)(at delivery)
- Incidence of adverse maternal side effects(from admnistration of the drug till the delivery of the baby)
研究者
Muritala Wakeel Okanlawon
Doctor, Lecturer/Consultant Obstetrician and Gynaecologist
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso