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.: PACTR202010913594375 Date of Approval: 30/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of Fetal Pulse Oximetry in determining fetal wellbeing during labour
Official scientific title The use of Fetal Pulse Oximetry in determining fetal wellbeing during labour: A non-randomized clinical trial
Brief summary describing the background and objectives of the trial No previous study of fetal pulse oximetry has accurately determined intrapartum fetal oxygenation. We describe a trial for the use of a novel type of fetal pulse oximetry device that, while in labor, touches the fetal presenting part in a non-invasive way, reads the fetal oxygen content and stores the data so the results are masked to those attending the parturient, allowing labor to be managed without prejudice. This will be a non-randomized clinical trial. The results of the novel fetal oximeter readings, once unmasked, will be compared to the clinically acceptable measures of fetal wellbeing in labor in our unit, that is, cardiotocogram (CTG) and scalp stimulation test in labor in guiding labor management choices, predicting cord blood gas results at delivery of the fetus and fetal outcomes. Primary Objective: To evaluate the use of an intrauterine fetal pulse oximeter device in comparison to other methods of fetal monitoring in determining fetal well-being in labour. Secondary Objectives. o To evaluate the value of fetal oxygen determination in the second stage of labor? o To assess the possibility of a true predictive value of the 60% critical threshold value and whether it will always be associated with pathological CTG/cord blood gases?
Type of trial CCT
Acronym (If the trial has an acronym then please provide) FPO
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/02/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fetal pulse oximetry The fetal oxygenation will be determined continuously during labour Duration of the labour and cease upon delivery Assessment of fetal oxygenation using fetal pulse oximeter during labour 50
Control Group Fetal cardiotocography In established labour In labour and cease upon delivery The well being of the baby as currently done using cardiotocography will be used as the control. Therefore, each patient will act as their own controls. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 18 years of age or older 2. Singleton gestation 3. More than 34 weeks’ gestation 4. Vertex presentation 5. Ruptured membranes 1. Patients on trial for vaginal delivery after cesarean section 2. Fetus with known congenital anomalies 3. Chorioamnionitis 4. Preeclampsia/Hemolysis Elevated Liver Enzymes Low Platelets (HELLP) syndrome 5. Suspected Small for Gestational Age (SGA)/Intra-uterine Growth Restriction (IUGR) 6. Stillbirth 7. Maternal pulmonary disease with O2 saturation in labor < 95% 8. Any condition that precludes ROM or vaginal delivery (placenta praevia) 9. Malpresentation 10. Human Immunodeficiency Virus (HIV) disease 11. Multifetal gestation 12. Gestational Diabetes Mellitus (GDM) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 10/07/2020 Aga Khan University
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, off Limuru Road, P. O. Box 30270 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Fetal oxygen determination in the second stage of labor In labour
Primary Outcome Comparison of an intrauterine fetal pulse oximeter device with other methods of fetal monitoring in determining fetal well-being in labour. In labour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital P.O. Box 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Third Parklands Avenue, P.O. Box 30270 Nairobi 00100 Kenya
AngeM Devices 8810 Wainwright Road Wyndmoor Pennsylvania 19038 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University 3rd Parklands Avenue, off Limuru Road, P. O. Box 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Felix Oindi Third Parklands Avenue, P.O. Box 30270 Nairobi 00100 Kenya
Marleen Temmerman Third Parklands Avenue, P.O. Box 30270 Nairobi 00100 Kenya
Mukaindo Mwaniki Third Parklands Avenue, P.O. Box 30270 Nairobi 00100 Kenya
Sikolia Wanyonyi Third Parklands Avenue, P.O. Box 30270 Nairobi 00100 Kenya
John Missanelli 8810 Wainwright Road, Wyndmoor Pennsylvania 19038 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Felix Oindi felix.oindi@aku.edu +254723499586 3rd Parklands Avenue, off Limuru Road, P. O. Box 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Senior Instructor
Role Name Email Phone Street address
Public Enquiries Mukaindo Mwaniki mukaindo.mwaniki@aku.edu +254721379862 3rd Parklands Avenue, off Limuru Road, P. O. Box 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Marleen Temmerman marleen.temmerman@aku.edu +254728629585 3rd Parklands Avenue, off Limuru Road, P. O. Box 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be made available for sharing after deidentification immediately following publication for a period of 36months. The Study Protocol and Informed Consent form and Clinical Study Report will also be made available. This will be made available for anyone wishing to access the data for any purpose through a link which will be provided for a period of 36months following article publication after which the information will be accessible at the University’s data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing date may be communicated through research.supportea@aku.edu. Informed Consent Form,Study Protocol Immediately following publication for a period of 36months Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
research.supportea@aku.edu. 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