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.: PACTR201805002872322 Date of Approval: 15/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title REPEAT INDUCTION VERSUS EXPECTANT MANAGEMENT AFTER FAILED PRIMARY LABOR INDUCTION AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL.
Official scientific title REPEAT INDUCTION VERSUS EXPECTANT MANAGEMENT AFTER FAILED PRIMARY LABOR INDUCTION AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL.
Brief summary describing the background and objectives of the trial BACKGROUND: While the rates of labor induction have increased globally,occurring in about 20% of almost all settings, Africa reports of an average rate of 4.4% (Kenya 3.9%) with a high rate of unmet need (66.0 ¿80.2%), which is a clear indicator for poor quality obstetric care as well as inadequate access to reproductive health care. Despite it being a common obstetric procedure, criteria for successful and failed induction of labor (IOL) have not been standardized and no universal consensus has been reached to date hence caesarean delivery is often erroneously perceived to be the solution to failed labor induction. Primary caesarean delivery (CS) rate due to failed IOL in Kenyatta National Hospital (KNH) is reported at 51.5% in contrast to 10% in the United States (U.S) and 3% in Australia. The need for uniformity in its definition and management in creating standards on both the duration and number of times the induction can be attempted emerges within this contextual framework and this creates necessity to study the value of repeat induction after failed primary labor induction. BROAD OBJECTIVE: To determine the efficacy of repeat induction versus expectant management after failed primary labor induction on reducing rates of subsequent failed induction at KNH. SPECIFIC OBJECTIVES: 1)To compare the final mode of delivery between women randomized to repeat induction and those randomized to expectant management following failed primary induction of labor at KNH. 2)To compare time from induction to active phase of labor, time from induction to second stage (induction-delivery interval) and time from induction to decision for CS between women undergoing repeat induction versus expectant management at KNH following failed primary induction of labor. 3)To compare the rates of adverse maternal and perinatal outcomes between women undergoing repeat induction versus expectant management at KNH following failed primary induction of labor.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied FAILED PRIMARY LABOR INDUCTION,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/12/2017
Actual trial start date 25/12/2017
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
Recruitment status Not yet recruiting
Publication URL NONE YET
Secondary Ids Issuing authority/Trial register
R/H/ 177/2017 STUDY REGISTRATION NUMBER IN KENYATTA NATIONAL HOSPITAL/ RESEARCH & PROGRAMS
P644/09/2016 KENYATTA NATIONAL HOSPITAL/ UNIVERSITY OF NAIROBI ETHICS RESEARCH COMMITTEE APPROVED STUDY NUMBER
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 Simple randomisation using a randomisation table created by a computer 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 REPEAT LABOR INDUCTION 25ug pv 4 hourly to a maximum of three doses 12 hours Second cycle of labor induction instituted with misoprostol administered as 25ug pv 4 hourly to a maximum of three doses after 24 hours resting period when the diagnosis of failed primary labor induction is perceived 43 Active-Treatment of Control Group
Control Group EXPECTANT MANAGEMENT not applicable 48 hours Defined as observation from the time the diagnosis of failed primary labor induction is perceived to 48 hours resting period followed by caesarean delivery if spontaneous labor does not result within the 48 hours time frame. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants to be included will be mothers for induction of labor with: 1.Singleton, live gestation in cephalic presentation 2.Gestation at or beyond 37 weeks 0 days (37 0/7) 3.Post-term pregnancy 4.Bishop score <6 at failed primary labor induction diagnosis 5.Reactive fetal heart rate pattern 6.Intact membranes 7.Oligohydramnios 8.Hypertensive disorders (preeclampsia without severe features and pregnancy induced hypertension) 9.Diabetes mellitus requiring insulin 10.Maternal cardiac disease: mild cardiac disorders 11.Fetal growth restriction without evidence of fetal compromise on Doppler U/S 12.Elective induction 13.Willing to participate and give a signed informed consent The participants to be excluded from primary and repeat IOL will be those who have: 1)Contraindications to induction Absolute: more than 2 previous uterine scar, previous myomectomy, malposition Relative: malpresentation, non reactivenonstress test, para>3, severe maternal heart disease, severe maternal hypertension, polyhydramnios 2)Contraindications to vaginal delivery e.g. contracted pelvis, type 4 placenta praevia, umbilical cord prolapse, active genital herpes infection, invasive cervical cancer 3)Multiple gestation 4)Estimated fetal weight >4000 or <2000 grams 5)Hypersensitivity to prostaglandins 6)Severe asthma 15 Year(s) 60 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 05/10/2017 KNH-UON ETHICS & RESEARCH COMMITTEE
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 20723-00202 NAIROBI 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Time from induction to active phase of labor: entry into active phase of labor within the designated time. This was chosen as a primary outcome in line with literature review that failed IOL should be defined as the inability to achieve active phase of labor. In this instance, final outcome of pregnancy (mode of delivery) which is associated with confounders is not considered. Time taken in hours between initiation of induction (administration of first dose of medication) and entry into active phase of labor
Secondary Outcome 1)Time from induction to second stage (induction-delivery interval) Time taken in hours between initiation of induction and entry into second stage of labor
Secondary Outcome 2)Time from induction to decision to perform CS Time taken in hours between initiation of induction to making decision to perform caesarean delivery
Secondary Outcome 3)Final mode of delivery: vaginal vs caesarean delivery AT DELIVERY OF THE BABY
Secondary Outcome 4)Adverse maternal outcome defined as or including maternal nausea, vomiting, diarrhea, postpartum haemorrhage, uterine hyperstimulation with FHR changes, uterine rupture, instrumental vaginal delivery, intensive care unit admission, chorioamnionitis, duration of hospital stay, maternal death From start of induction till 6 hours post delivery.
Secondary Outcome 5)Early neonatal morbidity defined as or including meconium-stained liquor, Apgar score less than seven at five minutes, NICU admission for more than 48 hours, neonatal encephalopathy, perinatal death At delivery of the baby.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KENYATTA NATIONAL HOSPITAL: Labor ward, antenatal wards and neonatal units KENYATTA NATIONAL HOSPITAL , HOSPITAL ROAD, P.O. BOX 20723 NAIROBI 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
RESEARCH & PROGRAMS: KENYATTA NATIONAL HOSPITAL P.O BOX 20723-00202 NAIROBI 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor RESEARCH & PROGRAMS: KENYATTA NATIONAL HOSPITAL P.O BOX 20723-00202 NAIROBI 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Lydia Okutoyi Kenyatta National Hospital, Department of Reproductive Health, P.O BOX 20723 Nairobi 00202 Kenya
Professor Koigi Kamau University of Nairobi, College of Health Sciences, P.O Box 30197 Nairobi 00100 Kenya
Dr. Alfred Osoti University of Nairobi, College of Health Sciences, P.O Box 30197 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Subaha Mohamed sabahhania@gmail.com +254720255153 P.O BOX 102081
City Postal code Country Position/Affiliation
Nairobi 00101 Kenya MMED OBGYN Resident in University of Nairobi
Role Name Email Phone Street address
Public Enquiries Subaha Mohamed sabahhania@gmail.com +254720255153 P.O BOX 102081
City Postal code Country Position/Affiliation
Nairobi 00101 Kenya MMED OBGYN Resident in University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Alfred Osoti alfredosoti@icloud.com +254733886664 University of Nairobi, P.O Box 30197
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Supervisor
REPORTING
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