Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Mother aged between 18- 49 years

2. Singleton pregnancy between 37+0 - 39+6 weeks gestation

3. Cephalic presentation

4. Foetus without any known structural, chromosomal or genetic abnormality

5. Planned vaginal delivery

Exclusion Criteria:

1. Women undergoing induction of labour as a result of foetal or maternal complications

2. Women in labour with Cervical dilatation > 8 cm,

3. Ruptured membranes with meconium stained liquor, or evidence of intrauterine infection.

4. Previous caesarean delivery

5. Foetus known to be small for gestational age, or suspected foetal growth restriction

6. 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.

7. 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

8. 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.