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.: PACTR201803003123163 Date of Approval: 20/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Obstetric outcomes following immedicate versus delayed intravenous Oxytocin after amniotomy among parturients: A randomized clinical trial
Official scientific title Obstetric outcomes following immedicate versus delayed intravenous Oxytocin after amniotomy among parturients: A randomized clinical trial
Brief summary describing the background and objectives of the trial Amniotomy or Artificial Rupture of Membranes (ARM)/ and Oxytocin administration (OA) are integral parts of active management of labour. It is, however, unclear how both ARM and OA should be combined in order to hasten labour and influence its outcomes. The most appropriate time of OA following amniotomy has not been clearly defined. The effect of shorter versus longer amniotomy to oxytocin administration interval on labour and delivery outcomes or on maternal experience and fetal or neonatal outcomes has not been extensively studied especially in resource constrained settings. Understanding the effect of the amniotomy to oxytocin administration interval on obstetric outcomes may improve maternal, fetal or neonatal outcomes and enhance women¿s positive labour experience BROAD OBJECTIVE: To compare obstetric outcomes in women under augmentation of labour at term receiving immediate versus delayed intravenous oxytocin following ARM in KNH Labour Ward in 2018. SPECIFIC OBJECTIVE: Among women in labour in KNH Labour Ward in 2018 randomized to immediate versus delayed intravenous oxytocin following ARM for augmentation of labour, to compare: ARM to delivery interval, mode of delivery, neonatal outcomes, maternal satisfaction, incidence of umbilical cord prolapse, incidence of uterine hyperstimulation, incidence of adverse neonatal outcomes and need for assisted vaginal delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied labour augmentation,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/02/2018
Actual trial start date 13/02/2018
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date 31/03/2018
Anticipated target sample size (number of participants) 202
Actual target sample size (number of participants) 202
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P678/11/2017 KNH UoN Ethics Research Committee
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 Permuted block randomization,10 blocks of 20, 1 block of 6 to arrive at 206 Allocation in identical, sealed, opaque envelopes up to the time of intervention Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immediate intravenous oxytocin following Amniotomy 5IU oxytocin in 500ml of Normal saline starting at 4 drops per minute and escalating by 4 drops every 30 minutes until 3 uterine contractions lasting 40 seconds or more are achieved in 10 minutes Amniotomy followed by 5IU oxytocin in 500ml of Normal saline starting at 4 drops per minute and escalating by 4 drops every 30 minutes 101
Control Group Delayed intravenous oxytocin following amniotomy 5IU oxytocin in 500ml of Normal saline starting at 4 drops per minute and escalating by 4 drops every 30 minutes until 3 uterine contractions lasting 40 seconds or more are achieved in 10 minute Amniotomy then two hour delay, before starting 5IU oxytocin in 500ml of Normal saline starting at 4 drops per minute and escalating by 4 drops every 30 minutes if indicated. 101 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant mothers who: 1.Provide informed consent 2.Have intact membranes at 37 completed weeks or greater. 3. Have singleton vertex pregnancies. 4.Require ARM (at cervical dilatation of 4 cm) for example due to inadequate uterine contractions or poor progress in labour. Pregnant mothers in labour with: 1.Multiple gestation. 2.Malpresentation (non-vertex) 3.Previously had uterine surgery. 4.Virally unsuppressed HIV infection. 5.Non-reassuring fetal status prior to amniotomy. 6.Post amniotomy meconium stained liquor, fetal tachycardia, fetal bradycardia, umbilical cord or limb prolapse. 7.Antepartum hemorrhage due to any cause. 8.Hypertensive disease, Diabetes and Cardiac disease in pregnancy. 9.Known/ suspected fetal growth restriction. 10.Parity > 5 (grand multipara) 18 Year(s) 45 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 02/02/2018 Kenyatta National Hopsital-University of NaIrobi Ethics Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road, Upper hill Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amniotomy to delivery duration in hours and minutes at time of delivery
Secondary Outcome Mode of delivery at time of delivery
Secondary Outcome maternal satisfaction with augmentation process within 24 hours of delivery
Secondary Outcome neonatal outcome 0-10 minutes following delivery
Secondary Outcome incidence of umbilical cord prolapse from time of amniotomy to delivery
Secondary Outcome incidence of uterine hyperstimulation from time of amniotomy to delivery
Secondary Outcome incidence of adverse neonatal outcomes 0-10 minutes following delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital road, Upperhill Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Kristina A. Sule State House Avenue Nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta National Hospital Hospital road, Upper hill Nairobi 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Onesmus Gachuno Hospital road, Upper hill Nairobi 00202 Kenya
Dr. Alfred Osoti Hospital road, Upper hill Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kristina Sule kris.sule@gmail.com +254770311224 State House Avenue
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Obstetrics and Gynecology resident at University of Nairobi-Kenyatta National Hospital
Role Name Email Phone Street address
Public Enquiries Onesmus Gachuno owgachuno@yahoo.com +254722851914 Hospital road, Upper hill
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior lecturer, department of Obstetrics and Gynecology. Consultant Obstetrician and Gynecologist
Role Name Email Phone Street address
Scientific Enquiries Alfred Osoti alfredosoti@icloud.com +254733886664 Hospital road, Upper hill
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer, department of Obstetrics and Gynecology. Consultant Obstetrician and Gynecologist
REPORTING
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