Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term
NCT ID: NCT05558176
Last Updated: 2022-09-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
176 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-04-08
Study Completion Date
2022-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Acute Preterm Labor: Nifedipen Alone or Combined With Cildenafil Citrate
NCT02337881
Labor Preterm Requiring Hospitalization
UNKNOWN
PHASE1
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
NCT02712125
Isolated (Idiopathic) Oligohydramnios
COMPLETED
PHASE2/PHASE3
PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot
NCT01274637
Venous Thromboembolism
Postpartum
COMPLETED
PHASE3
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
NCT06968481
Post Partum Hemorrhage
NOT_YET_RECRUITING
PHASE2
Labor Induction in Preeclampsia High-risk Women
NCT05056467
Pre-Eclampsia
Induction of Labor
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
All consented booked participants will be recruited at antenatal clinic at term (37+0 to 39+6 weeks). Participants shall be duly educated about the study procedure at the antenatal educational sessions. This information will be re-emphasised on arrival in labour ward.
Introduction of the study to the Participants:
The study procedure will be explained to the participants during antenatal education session as in appendix I (Information on the study procedure to participants) before the consent will be signed. Sufficient time will be afforded to potential participants to ensure they, and their support person (where applicable), can make an informed decision about their participation.
Data Collection After recruitment, selection of patients into each arm of the study will be through a computer generated sequence in a 1:1 ratio to receive either sildenafil citrate or placebo in variable blocks of up to six (Stata Statistical Software, Release 14; College Station, TX; StataCorp LP. StataCorp 2013) in a sealed opaque envelope. Each participant's study identification number will be recorded in the clinical notes and subsequently in their electronic health records.
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. 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. The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra), this will be produced by TUYIL pharmaceutical company, Yidi road, Ilorin, Kwara state.
These will be stored in a locked drug cabinet in the birth suite. The midwife caring for each participant will then cross referenced the appropriate study pack with the study identification number recorded in the clinical notes and administered the trial tablet as specified in the protocol. Women, clinicians, and principal investigator will be unaware of allocation.
I (under the supervision of consultant radiologist) or a senior registrar in the department of radiology dedicated to the study will perform an ultrasound scan to measure indices of foetal and uteroplacental perfusion before and 2-4 hours after the initial dose of study medication.
An ultrasound scan will be performed to measure foetal biometry as well as Doppler resistance indices in the umbilical artery, umbilical vein, and middle cerebral artery. All ultrasound scans will be performed by me (principal investigator, under the supervision of consultant radiologist) or a senior registrar in the radiology department using a Voluson ultrasound machine with a 4- to 8-MHz curvilinear transabdominal transducer. To avoid caval compression, women will be positioned in a slightly left tilt supine position with the head of the bed elevated.
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.
Participants presenting for induction of labour, depending on the Modified Bishop's Score, induction of labour will be performed with balloon catheters or vaginal prostaglandin E1 analogue. In women with a favourable cervix, artificial rupture of membranes will be performed followed by an oxytocin infusion.
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. Heart rate abnormalities will be classified using Royal College of Obstetricians and Gynaecologists (RCOG)/ National Institute for Clinical Excellence (NICE) categorisation of foetal heart rate feature.60 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 with any concerning characteristics\* in over 50% of contractions for less than 30 minutes OR 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
Subsidiary intrapartum and neonatal outcomes will include mode of birth (caesarean delivery, instrumental or spontaneous vaginal birth), indication for operative birth, length of labour (from time of active labour (cervical dilatation of \> 4 cm to delivery of the infant), foetal heart rate abnormalities, meconium-stained liquor, postpartum haemorrhage (blood loss \>500 mls), maternal intensive care unit admission, APGAR score at 5 minutes and, if admission to the special care baby unit (SCBU) occurred, length of stay, respiratory illness (transient tachypnoea of the newborn or pneumothorax), or neonatal encephalopathy.
Newborns will be screened for major Cardio-pulmonary disease and pulmonary hypertension by measuring oxygen saturation by pulse oximetry within 8 hours of birth.
Maternal symptoms potentially related to sildenafil citrate administration (nausea, vomiting, flushing, hypotension, blurred vision, visual loss, headache, dyspepsia, diarrhoea, and tremor) will be looked for and recorded.
All participants will be followed up within 48 hours of delivery. Medical records will be reviewed and intrapartum and neonatal outcome details recorded. The indication for operative delivery will be noted as recorded by the obstetric team.
In all cases, to ensure consistency of interpretation, intrapartum monitoring will be reviewed by two senior members of the obstetric team before a decision for intrapartum caesarean delivery for presumed foetal compromise will be performed.
Data Management The Proforma will be sorted out, entered into a computer and the obtained data will be analyzed using IBM (International Business Machines Corporation) SPSS (Statistical Product and Service Solutions) version 21. The method of data analysis will be as per-protocol i.e. data that will be included in the analysis will include only those participants who completed the treatment originally allocated to them as per protocol (data from participants who did not complete the treatment allocated to them or who did not comply with the protocol will not be included).
Categorical variables such as the socio-demographic status 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 on the contingency tables and statistical significance will be set at p values of less than 0.05.
Quantitative data e.g. gestational age will be presented as mean (standard deviation) or median (interquartile range). Differences between study groups will be compared with the Student t test and expressed as relative risk (RR), 95% confidence intervals (95% CIs). Ultrasound Doppler indices for MCA, UA, and cerebroplacental ratio will be converted to z scores using gestation-specific centiles,164 a p value of \<0.05 will be deemed statistically significant.
Ethical Consideration The respondents will be informed that participation is voluntary and they will not suffer any consequence if they choose not to participate. All information gathered will be kept confidential. Participants will only be identified by hospital number without their name. Data obtained from the study will be stored in my personal passworded computer.
Ethical clearance will be obtained from the ethical committee of LTH Ogbomoso and permission will be obtained from the obstetrics and gynaecology head of department and Consultants staff to enrol their patients. All participants will receive written information about the study, it will be emphasized that the use of sildenafil citrate in labour is experimental and that it is not currently licensed for use for any obstetric indication. Sufficient time will be afforded to potential participants to ensure they, and their support person (where applicable), can make an informed decision about their participation and written informed consent will be obtained.
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:
All consented booked participants will be recruited at antenatal clinic at term (37+0 to 39+6 weeks). Participants shall be duly educated about the study procedure at the antenatal educational sessions. This information will be re-emphasised on arrival in labour ward.
Introduction of the study to the Participants:
The study procedure will be explained to the participants during antenatal education session as in appendix I (Information on the study procedure to participants) before the consent will be signed. Sufficient time will be afforded to potential participants to ensure they, and their support person (where applicable), can make an informed decision about their participation.
Data Collection After recruitment, selection of patients into each arm of the study will be through a computer generated sequence in a 1:1 ratio to receive either sildenafil citrate or placebo in variable blocks of up to six (Stata Statistical Software, Release 14; College Station, TX; StataCorp LP. StataCorp 2013) in a sealed opaque envelope. Each participant's study identification number will be recorded in the clinical notes and subsequently in their electronic health records.
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. 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. The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra), this will be produced by TUYIL pharmaceutical company, Yidi road, Ilorin, Kwara state.
These will be stored in a locked drug cabinet in the birth suite. The midwife caring for each participant will then cross referenced the appropriate study pack with the study identification number recorded in the clinical notes and administered the trial tablet as specified in the protocol. Women, clinicians, and principal investigator will be unaware of allocation.
I (under the supervision of consultant radiologist) or a senior registrar in the department of radiology dedicated to the study will perform an ultrasound scan to measure indices of foetal and uteroplacental perfusion before and 2-4 hours after the initial dose of study medication.
An ultrasound scan will be performed to measure foetal biometry as well as Doppler resistance indices in the umbilical artery, umbilical vein, and middle cerebral artery. All ultrasound scans will be performed by me (principal investigator, under the supervision of consultant radiologist) or a senior registrar in the radiology department using a Voluson ultrasound machine with a 4- to 8-MHz curvilinear transabdominal transducer. To avoid caval compression, women will be positioned in a slightly left tilt supine position with the head of the bed elevated.
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.
Participants presenting for induction of labour, depending on the Modified Bishop's Score, induction of labour will be performed with balloon catheters or vaginal prostaglandin E1 analogue. In women with a favourable cervix, artificial rupture of membranes will be performed followed by an oxytocin infusion.
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. Heart rate abnormalities will be classified using Royal College of Obstetricians and Gynaecologists (RCOG)/ National Institute for Clinical Excellence (NICE) categorisation of foetal heart rate feature.60 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 with any concerning characteristics\* in over 50% of contractions for less than 30 minutes OR 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
Subsidiary intrapartum and neonatal outcomes will include mode of birth (caesarean delivery, instrumental or spontaneous vaginal birth), indication for operative birth, length of labour (from time of active labour (cervical dilatation of \> 4 cm to delivery of the infant), foetal heart rate abnormalities, meconium-stained liquor, postpartum haemorrhage (blood loss \>500 mls), maternal intensive care unit admission, APGAR score at 5 minutes and, if admission to the special care baby unit (SCBU) occurred, length of stay, respiratory illness (transient tachypnoea of the newborn or pneumothorax), or neonatal encephalopathy.
Newborns will be screened for major Cardio-pulmonary disease and pulmonary hypertension by measuring oxygen saturation by pulse oximetry within 8 hours of birth.
Maternal symptoms potentially related to sildenafil citrate administration (nausea, vomiting, flushing, hypotension, blurred vision, visual loss, headache, dyspepsia, diarrhoea, and tremor) will be looked for and recorded.
All participants will be followed up within 48 hours of delivery. Medical records will be reviewed and intrapartum and neonatal outcome details recorded. The indication for operative delivery will be noted as recorded by the obstetric team.
In all cases, to ensure consistency of interpretation, intrapartum monitoring will be reviewed by two senior members of the obstetric team before a decision for intrapartum caesarean delivery for presumed foetal compromise will be performed.
Data Management The Proforma will be sorted out, entered into a computer and the obtained data will be analyzed using IBM (International Business Machines Corporation) SPSS (Statistical Product and Service Solutions) version 21. The method of data analysis will be as per-protocol i.e. data that will be included in the analysis will include only those participants who completed the treatment originally allocated to them as per protocol (data from participants who did not complete the treatment allocated to them or who did not comply with the protocol will not be included).
Categorical variables such as the socio-demographic status 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 on the contingency tables and statistical significance will be set at p values of less than 0.05.
Quantitative data e.g. gestational age will be presented as mean (standard deviation) or median (interquartile range). Differences between study groups will be compared with the Student t test and expressed as relative risk (RR), 95% confidence intervals (95% CIs). Ultrasound Doppler indices for MCA, UA, and cerebroplacental ratio will be converted to z scores using gestation-specific centiles,164 a p value of \<0.05 will be deemed statistically significant.
Ethical Consideration The respondents will be informed that participation is voluntary and they will not suffer any consequence if they choose not to participate. All information gathered will be kept confidential. Participants will only be identified by hospital number without their name. Data obtained from the study will be stored in my personal passworded computer.
Ethical clearance will be obtained from the ethical committee of LTH Ogbomoso and permission will be obtained from the obstetrics and gynaecology head of department and Consultants staff to enrol their patients. All participants will receive written information about the study, it will be emphasized that the use of sildenafil citrate in labour is experimental and that it is not currently licensed for use for any obstetric indication. Sufficient time will be afforded to potential participants to ensure they, and their support person (where applicable), can make an informed decision about their participation and written informed consent will be obtained.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Foetal Hypoxia
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Selection of patients into each arm of the study will be through a computer generated sequence in a 1:1 ratio to receive either sildenafil citrate or placebo in variable blocks of up to six (Stata Statistical Software, Release 14; College Station, TX; StataCorp LP. StataCorp 2013) in a sealed opaque envelope. Each participant's study identification number will be recorded in the clinical notes.
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. The same brand of sildenafil citrate
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. The same brand of sildenafil citrate
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Group Type
ACTIVE_COMPARATOR
Sildenafil citrate
Intervention Type
DRUG
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.
Placebo
The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra).
Group Type
PLACEBO_COMPARATOR
Sildenafil citrate
Intervention Type
DRUG
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sildenafil citrate
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.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Viagra
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
49 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muritala Wakeel Okanlawon
Doctor, Lecturer/Consultant Obstetrician and Gynaecologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
WAKEEL MURITALA
Role: PRINCIPAL_INVESTIGATOR
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso,Oyo State, Nigeria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynaecology, LAUTECH Teaching Hospital
Ogbomoso, Oyo State, Nigeria
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Nigeria
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LadokeAkintolaU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
NCT00565383
COMPLETED
NA
Induction of Labor in Breech Presentation
NCT07071662
RECRUITING
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
NCT03581214
COMPLETED
NA
In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine
NCT05511415
COMPLETED
NA
VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
NCT02733835
UNKNOWN
PHASE4
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
NCT02932319
TERMINATED
NA
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
NCT05873218
RECRUITING
PHASE4
In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol
NCT03434444
COMPLETED
NA
Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes
NCT03625518
UNKNOWN
EARLY_PHASE1
Prevention of Post-partum Haemorrhage
NCT01044082
COMPLETED
NA
Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
NCT05251610
COMPLETED
NA
Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes
NCT04813874
WITHDRAWN
Phenylephrine for Spinal Induced Hypotension
NCT00781157
COMPLETED
PHASE4
The Effect of Entonox on Stages of Labor in Nulliparous Women
NCT04321642
COMPLETED
NA
Fetal Pillow Randomized Controlled Trial
NCT03342508
COMPLETED
NA
Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery
NCT05970770
UNKNOWN
PHASE4
Amniotomy and Oxytocin for Augmentation of Labour
NCT02318121
COMPLETED
PHASE2
Maternal Oxygen Supplementation for Intrauterine Resuscitation
NCT05681624
RECRUITING
NA
Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin
NCT06960850
NOT_YET_RECRUITING
NA
Anaesthetic Management of Women With Heart Disease For Labor and Delivery
NCT00403871
COMPLETED
Elevation of the Fetal Buttocks Prior to External Cephalic Version
NCT04538261
TERMINATED
NA
Intrapartum Ultrasonography in Evaluation of the Progress of Labor
NCT05823610
UNKNOWN
Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor
NCT03395730
UNKNOWN
PHASE2
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
NCT05314257
UNKNOWN
PHASE2/PHASE3
Use of Decision Support in the Management of Labour
NCT02010710
COMPLETED
NA