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

NCT05558176 | Unknown Phase 4 DMC

• 1 other identifier: LadokeAkintolaU
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foetal Hypoxia

Keywords

foetal compromise; foetal distress; caesarean section

Outcome Measures

Primary Outcomes (1)

• Incidence of non-reassuring foetal heart rate patterns

  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;

  from admnistration of the drug till the delivery of the baby

Secondary Outcomes (7)

• 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 fresh meconium-stained liquor

  from admnistration of the drug till the delivery of the baby

• Incidence of adverse neonatal outcomes ( APGAR score <7 at 5 minutes)

  at delivery

• Rate of admission to the Special Care Baby Unit (SCBU)

  at delivery

Study Arms (2)

Sildenafil citrate arm

ACTIVE COMPARATOR

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

Drug: Sildenafil citrate

Placebo

PLACEBO COMPARATOR

The placebo will be a vitamin C of the same size, colour and shape with sildenafil (Viagra).

Drug: Sildenafil citrate

Interventions

Sildenafil citrate 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.

Also known as: Viagra

Placebo; Sildenafil citrate arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, LAUTECH Teaching Hospital

Ogbomoso, Oyo State, 210271, Nigeria

RECRUITING

MeSH Terms

Conditions

Fetal Hypoxia; Fetal Distress

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• WAKEEL MURITALA

  Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso,Oyo State, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WAKEEL MURITALA

CONTACT

+2347032045565; womuritala@lautech.edu.ng

TAIBAT ADESOPE

CONTACT

+2347034985480; taibatadesope@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Lecturer/Consultant Obstetrician and Gynaecologist

Model Details: 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

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 28, 2022
• Study Start: April 8, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: from 6 months

Locations

NG (1)