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.: PACTR202202769135894 Date of Approval: 01/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFICACY OF VAGINAL MISOPROSTOL AND CERVICAL FOLEY CATHETER VERSUS VAGINAL MISOPROSTOL ALONE ON TERM PREGNANCY LABOUR INDUCTION IN ENUGU: A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFICACY OF VAGINAL MISOPROSTOL AND CERVICAL FOLEY CATHETER VERSUS VAGINAL MISOPROSTOL ALONE ON TERM PREGNANCY LABOUR INDUCTION IN ENUGU: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial One hundred and thirty two (132) eligible pregnant women will be recruited in this study and randomly allotted into two groups. Group A consists of 66 women on synchronous 25μg of vaginal misoprostol and cervical Foley catheter insertions while Group B consists of 66 women on 25μg of vaginal misoprostol insertions alone. This study will be carried out at the University of Nigeria Teaching Hospital, ESUT Teaching Hospital, and Annunciation Specialist Hospital in Enugu metropolis. Data on induction-delivery interval, mode of delivery and vaginal deliveries within 24 hours, need for oxytocin augmentation, complications and feto-maternal outcomes will be compared among the two groups. Statistical Analysis Data will be analyzed with Statistical Package for Social Sciences software (IBM Chicago) version 23.All analysis will be done at the 95% level of significance and a P<0.05 will be considered statistically significant.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fetomaternal
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 07/10/2022
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants) 132
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaginal misoprostol and cervical Foley catheter insertion 25μg of vaginal misoprostol will be inserted 4 hourly for maximum of 4 doses 24 hours Once a participant recruited for the study from antenatal clinic enters the labour ward where cervical ripening/induction of labour will take place, there will be an initial participant’s re-assessment to ensure that there is no contraindication to labour induction. This will be followed by re-counseling, addressing of research participant’s concerns and obtaining written informed consent, and then followed by non-stress test, cervical assessment with modified Bishop’s score and grouping/cross matching of two units of blood. The Foley catheter and misoprostol will be collected from the designated tray in the labour ward. Attending researcher or research assistant will observe aseptic procedure during the process of insertion of the misoprostol and / or Foley catheter, patient will be placed in dorsal position, and vulva/vagina will be cleaned with a solution of chlorhexidine. This will be followed by the introduction of appropriately sized sterile speculum into the vagina to expose the cervix. The anterior lip of the cervix will be held with a sponge holding forceps under good light source, then size 18 Foley catheter will be introduced into the endocervical canal with another sponge holder and its balloon inflated with 50mls of sterile water. The catheter will be strapped into the maternal thigh with a plaster after ensuring that it is taut. This will be followed immediately by insertion of low-dose (25μg) misoprostol at the posterior vaginal fornix and to be repeated 4hourly for a maximum of four (4) doses over 24hours. The cervical status will be re-assessed after 4hours of the insertion of the last dose of misoprostol or whenever patients develops intermittent abdominal pains to determine and document the Bishop’s score until the cervix becomes favourable. 66
Control Group vaginal misoprostol insertion alone 25μg 24 hours Once a participant recruited for the study from antenatal clinic enters the labour ward where cervical ripening/induction of labour will take place, there will be an initial participant’s re-assessment to ensure that there is no contraindication to labour induction. This will be followed by re-counseling, addressing of research participant’s concerns and obtaining written informed consent, and then followed by non-stress test, cervical assessment with modified Bishop’s score and grouping/cross matching of two units of blood. The misoprostol to be used will be collected from the designated tray in the labour ward. The attending researcher or research assistant will observe aseptic procedure throughout the insertion of misoprostol per vaginam. Patient will be placed in dorsal position, and the vulva and vagina will be cleaned with a solution of chlorhexidine. Each research participant in this arm will receive low dose (25μg) misoprostol into the posterior fornix of the vagina which will be introduced by the researcher or research assistant 4hourly until a maximum of four (4) doses or the cervix is considered to be favourable (Bishop’s score of ≥6). Cervical status will be re-assessed until favourable Bishop Score is noticed at each time the next dose of misoprostol is due or when patient begins to have regular intermittent abdominal pains 66 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Every pregnant woman billed for labour induction at term (37 completed weeks to 41weeks + 6days gestation) with an unfavourable cervix (Bishop score of< 6) who gave consent, with live singleton fetus in longitudinal lie, cephalic presentation and reactive non-stress test will be selected. Pregnant women at term who fail to give consent, with contraindication to vaginal delivery, multiple gestation, intrauterine fetal death, anomalous fetus, nonreactive stress test, prior uterine rupture/surgery, regular uterine contraction, vaginal bleeding, and premature rupture of membranes will be excluded. Adult: 19 Year-44 Year 19 Year(s) 44 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 20/11/2021 Health Research Ethics CommitteeUniversity of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu 40001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean time interval it will take to achieve vaginal delivery from the time of induction At delivery
Secondary Outcome Proportion of women that will achieve vaginal delivery,need for oxytocin administration. Others will include feto- maternal outcomes by checking and comparing the mean Apgar scores at 1 and 5 minutes, birth asphyxia (using the Apgar scores), use of oxygen on babies, admission into neonatal intensive care unit(NICU) and occurrence of complications such as uterine tachysystole /hyperstimulation (more than five uterine contractions in ten minutes for two consecutive ten minutes periods), uterine hypertonus (uterine contractions lasting more than 90seconds), hyperstimulation syndrome (tachysystole or hypertonus associated with fetal distress), uterine rupture and fetal heart rate abnormalities, failed induction resulting in caesarean delivery. During labour and 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 40001 Nigeria
ESUT Teaching Hospital GRA Enugu 40001 Nigeria
Annunciation Specialist Hospital Emene Enugu 40001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Ezenwaeze Malachy Nwaeze No 4 Umunnajingene Street,Republic Estate Enugu 40001 Nigeria Individual
Secondary Sponsor Dr. Leonard Ogbonna Ajah No 18 Uwandu Crescent,Monarch,Enugu Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Malachy Ezenwaeze malachynwaeze@gmail.com +2348068092391 No 4 umunnajingene ,Republic Layout
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior Resident Doctor
Role Name Email Phone Street address
Public Enquiries Monique Ajah monique.ajah@unn.edu.ng +2348037331696 No 18 Uwandu Crescent ,Monarch
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Assistant Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 No 18 Uwandu Crescent ,Monarch
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Reader in Obstetrics and Gynaecology University of Nigeria Nsukka
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months to 2 years after publication Not yet avaialble
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