Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term
Foetal Hypoxia
About this trial
This is an interventional prevention trial for Foetal Hypoxia focused on measuring foetal compromise, foetal distress, caesarean section
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Obstetrics and Gynaecology, LAUTECH Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Sildenafil citrate arm
Placebo
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
The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra).