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.: PACTR201604001535825 Date of Registration: 14/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Induction of labour
Official scientific title A COMBINATION OF FOLEY BALOON AND MISOPROSTOL VERSUS MISOPROSTOL ALONE FOR INDUCTION OF LABOUR AT KENYATTA NATIONAL HOSPITAL, A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial The World Health Organization (WHO) defines induction of labor as the initiation of labor by artificial means prior to its spontaneous onset at a viable gestational age with the aim of achieving vaginal delivery in a pregnant woman with intact membranes. Successful labor induction leads to vaginal birth while failed induction is the inability to achieve more than 3 cm cervical dilatation after 24 hours of induction of labor. Failed induction is an expected outcome of induction of labor. Combination methods of induction of labor may reduce the high failed induction rates reported by misoprostol or Foley catheter balloon alone. The proposed study aims to find out if combined methods have a higher success rate, one arm will utilize misoprostol alone and the other combined misoprostol with Foley¿s catheter. The outcomes will include successful induction, maternal and early neonatal outcomes. Failed induction or prolonged duration of induction to delivery may increase costs, patient anxiety, and if not monitored well especially in the setting of heavy workload may lead to poor neonatal outcomes. If induction of labor using combined Foley and misoprostol can reverse or reduce these outcomes then it can change guidelines on induction of labor or for those patients at risk of failed induction. It will be done on pregnant women admitted for induction of labor at KNH at gestational age of 28 weeks and beyond. SPECIFIC OBJECTIVES Among pregnant women undergoing cervical ripening and induction of labor using combined misoprostol and Foley balloon versus misoprostol alone, 1. Determine
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
Disease(s) or condition(s) being studied ,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2015
Actual trial start date 10/10/2015
Anticipated date of last follow up 30/04/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
n/a (P71/02/2015)
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 by a computer generated software program Sealed opaque envelopes Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group combined foley baloon with misoprostol 25micrograms 6 hourly 24 hours folay balloon plus misoprostol given concurently 90 Active-Treatment of Control Group
Experimental Group foley baloon plus misoprostol 25mg 6 hourly 24 hours foley ballon and misoprostol 25mcg inserted simultaneously 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any mother with one or more of the following indications will be included in the study. These include late term or post term pregnancies, pre eclampsia, chronic hypertension, gestational diabetes, oligohydramnios, or intrauterine Fetal Demise Intrauterine Growth Restriction, Previous cesarean sections, multiple gestation, contraindication to prostaglandins, fetal anomalies, other uterine surgeries, Estimated Fetal Weight more than 4000G,Placenta previa, Non Reassuring Fetal Status, multiparity more than 5,HIV infected and those not sure of dates by clinical examination as well as ultrasound dating. 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 27/05/2015 KNH/UON
Ethics Committee Address
Street address City Postal code Country
OFF MBAGATHI ROAD NAIROBI 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome normal delivery fall of baloon catheter,delivery of the baby
Secondary Outcome Normal delivery At delivery of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National hospital off mbagathi road nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
KNH 00202 nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KNH RESEARCH AND PROGRAMS off mbagathi road nairobi 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
NONE NONE NONE 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator davies kibii davyzkibii@yahoo.co.uk 254721578173 knh
City Postal code Country Position/Affiliation
nairobi 00202 Kenya principal investigator
Role Name Email Phone Street address
Scientific Enquiries alfred osoti alfredosoti@icloud.com 24733886664 nairobi
City Postal code Country Position/Affiliation
nairobi 00202 Kenya supervisor
Role Name Email Phone Street address
Scientific Enquiries innocent maranga drmaranga@gmail.com 254722444805 knh
City Postal code Country Position/Affiliation
nairobi 00202 Kenya supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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