Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303797356166 Date of Approval: 22/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sildenafil citrate to improve maternal and neonatal outcomes in low-resource settings: a randomized feasibility trial
Official scientific title Sildenafil citrate to improve maternal and neonatal outcomes in low-resource settings: a randomized feasibility trial
Brief summary describing the background and objectives of the trial Birth asphyxia, defined by the WHO as failure to establish spontaneous breathing at birth, accounts for nearly 1 million neonatal deaths annually.1,2 Birth asphyxia is the second most common cause of neonatal mortality worldwide.1,2 The primary cause of birth asphyxia is poor perfusion of the fetus by the placenta during labor, which may lead to non-reassuring fetal status (fetal distress), hypoxic injury, or death. Currently, there are no evidence-based therapies to improve fetal perfusion during labor in cases of severe fetal compromise. Urgent operative delivery is the only option to restore gas exchange to the baby. In low-resource settings, intrapartum fetal monitoring may not be available to detect fetal distress and access to urgent operative delivery to relieve distress may be limited. Thus, a high burden of death due to birth asphyxia is carried in the developing world. Feasible therapies for use in low-resource settings to reduce deaths from birth asphyxia are urgently needed. Sildenafil citrate is a novel approach to reduce fetal distress during labor
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2023
Actual trial start date
Anticipated date of last follow up 01/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sildenafil citrate 50 mg of oral sildenafil citrate given every 8 hours up to three dose during labor 8-24 hours 50 mg of oral sildenafil citrate given every 8 hours up to three dose during labor 250
Control Group Control An identical placebo to the study drug will be administered, 50 mg orally every 8 hours during labor up to 3 doses 8-24 hours An identical placebo to the study drug will be administered, 50 mg orally every 8 hours during labor up to 3 doses 250 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Pregnant women presenting in early labor with a term pregnancy (≥37 weeks gestation) o Early labor will be defined as cervical dilation less than or equal to 6 cm o Gestational age will be calculated from the most reliable variable using the following hierarchy of reliability: 1) gestational dating ultrasound completed at any time during the pregnancy (with preference to the earliest exam), 2) date of last menstrual period if menses are regular ● Planned vaginal delivery ● Maternal age 18-50 years or an emancipated minor according to local standards ● A single, live fetus in cephalic presentation confirmed prior to randomization ● Unknown gestational age ● Maternal history of caesarian delivery ● Maternal contraindication to sildenafil therapy such as hypersensitivity to nitrates or nitrites ● Recognized fetal anomaly ● Any maternal medical condition or status that precludes informed consent Adult: 19 Year-44 Year 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/04/2023 University of Alabama at Birmingham IRB
Ethics Committee Address
Street address City Postal code Country
701 20th Street South Birmingham 35233 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/08/2022 Egerton University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
George Morara Rd Nakuru Kenya Nakuru Pobox536 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring 2) Define the rate of and indication for operative delivery 3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality 4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites 5) Estimate effect size of the intervention on the incidence of the composite neonatal outcome including perinatal mortality and/or bag and mask resuscitation at birth Objectives will be measured in pregnant female during labor and 24 hours following exposure to study drug. In the neonate objectives will be measured at birth and at 7 days of life.
Secondary Outcome As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring 2) Define the rate of and indication for operative delivery 3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality 4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites 5) Estimate effect size of the intervention on the incidence of the composite neonatal outcome including perinatal mortality and/or bag and mask resuscitation at birth Objectives will be measured in pregnant female during labor and 24 hours following exposure to study drug. In the neonate objectives will be measured at birth and at 7 days of life.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nakuru County Referral Hospital Show Ground Road Nakuru Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Alabama at Birmingham 1701 2nd Ave S Birmingham 35294 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Alabama at Birmingman 1701 2nd Ave S Birmingham United States of America University
COLLABORATORS
Name Street address City Postal code Country
Egerton University Biashara kilimo road Nakuru Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nora Switchenko nswitchenko@gmail.com +18607981557 2169 e 3205 s
City Postal code Country Position/Affiliation
Salt Lake City 84109 United States of America Clinical Assistant Professor
Role Name Email Phone Street address
Public Enquiries Nora Switchenko nswitchenko@gmail.com +18607981557 2169 e 3205 s
City Postal code Country Position/Affiliation
Salt Lake City United States of America Clinical assistant professor
Role Name Email Phone Street address
Scientific Enquiries Nora Switchenko nswitchenko@gmail.com +18607981557 2169 e 3205 s
City Postal code Country Position/Affiliation
Salt lake city United States of America Clinical assistant professor
Role Name Email Phone Street address
Principal Investigator Amos Otara amosotara@yahoo.com 254722747470 PO Box 13419
City Postal code Country Position/Affiliation
Nakuru Kenya Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share all of the individual participant data collected during the trial, after deidentification. Those requesting data can contact Nora Switchenko at nswitchenko@gmail.com. Informed Consent Form,Study Protocol Sharing will begin 3 months and ending 5 years following article publication. All requests for data will be granted. Those requesting data can contact Nora Switchenko at nswitchenko@gmail.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information