Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso