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.: PACTR201709002509200 Date of Approval: 09/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized Controlled Trial of Sequential Versus Simultaneous Use of Foley Balloon and oxytocin for Induction of Labor in Nulliparous pregnant women
Official scientific title A Randomized Controlled Trial of Sequential Versus Simultaneous Use of Foley Balloon and oxytocin for Induction of Labor in Nulliparous pregnant women
Brief summary describing the background and objectives of the trial Pre-induction cervical ripening with the trans-cervical Foley balloon is a proven, safe and effective method. There is paucity of literature regarding the timing of initiation of oxytocin following insertion of Foley catheter. Oxytocin may be started simultaneous to the Foley catheter or sequentially after the Foley catheter is expelled. The sequential method is used in our set up but studies have shown that the simultaneous method shortens the induction to delivery time without increasing the cesarean section rate. This study is going to be conducted with an objective of determining whether the induction of labor with simultaneous use of oxytocin and Foley balloon decreases the time to delivery in nulliparous women as compared to sequential use of Foley balloon followed by oxytocin. A randomized clinical trial of nulliparous women presenting for induction of labor at Saint Paul¿s Hospital will be conducted to determine whether simultaneous versus sequential use of Foley balloon with oxytocin decreases induction to delivery time. A total of 140 women will be recruited and 70 will be started on simultaneous trans-cervical Foley balloon insertion with oxytocin while the rest 70 will be started on sequential oxytocin after Foley catheter is expelled or was put in place for 12 hours whichever comes first. The primary outcome will be the induction to delivery time. Secondary outcomes included are cesarean delivery rate, rates of chorioamnionitis, estimated blood loss, rates of postpartum hemorrhage and a composite neonatal outcome. An intention-to-treat (ITT) analyses will be performed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Maternal health - Induction of labor,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 18/09/2017
Actual trial start date 12/11/1919
Anticipated date of last follow up 11/05/2020
Actual Last follow-up date 11/05/2020
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sequential use of cervical Foley catheter and Oxytocin According to the department protocol Until delivery or and indication to stop induction arise whichever comes first Cervical ripening with Foley catheter first followed by commencement of oxytocin induction 70
Experimental Group Simultaneous use of Cervical Foley catheter and Oxytocin According to the protocol Until delivery or and indication to stop induction arise whichever comes first Simultaneous use of Cervical Foley catheter and oxytocin induction 70 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparous women 28 weeks¿ gestational age; with a live, non-anomalous singleton fetus in vertex presentation; with an initial cervical dilation <3 cm; who were admitted for induction of labor for indications determined by their primary provider; and in whom cervical ripening with Foley balloon was planned are eligible for enrollment. Patients with prior uterine surgery, unexplained vaginal bleeding, any history of latex allergy or any contraindication to vaginal delivery will be excluded. 18 Year(s) 49 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 30/08/2017 The National Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Swaziland street Addis Ababa 2490 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Induction to delivery time Insertion of cervical Foley balloon catheter Delivey
Secondary Outcome cesarean delivery rate, rates of chorioamnionitis, estimated blood loss, rates of postpartum hemorrhage and a composite neonatal outcome Time of delivery First 24 hours postpartum First seven days after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Saint Paul's Hospital Mellinnium Medical College Swaziland Street Addis Ababa 1271 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Center for International Reproductive Health Training Ethiopia - CIRHT Ethiopia Swaziland street Addis Ababa 1271 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saint Paul's Hospital Millennium Medical College Swaziland street Addis Ababa 1271 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Lemi Belay (MD) Swaziland street Addis Ababa 1271 Ethiopia
Mohamed Sherif (MD) Swaziland street Addis Ababa 1271 Ethiopia
Balkachew Nigatu (MD) Swaziland street Addis Ababa 1271 Ethiopia
Delayehu Bekele (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Birhanu Kebede (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Alula M. Teklu (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Malede Birara (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Abdulfeta Abdulkadir (MD) Swaziland street Addis Ababa 1271 Ethiopia
Birhanu Kebede (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Alula M. Teklu (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Malede Birara (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Abdulfeta Abdulkadir (MD) Swaziland street Addis Ababa 1271 Ethiopia
Birhanu Kebede (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Alula M. Teklu (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Malede Birara (MD, MPH) Swaziland street Addis Ababa 1271 Ethiopia
Abdulfeta Abdulkadir (MD) Swaziland street Addis Ababa 1271 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Delayehu Bekele delayehu@gmail.com +251922743743 Swaziland street
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Associate Professor of Obstetrics and Gynecology, Saint Paul's Hospital Millennium Medical College
Role Name Email Phone Street address
Public Enquiries Balikachew Nigatu balkewnega@gmail.com +251911374910 Swaziland street
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Associate Professor of Obstetrics and Gynecology, Saint Paul's Hospital Millennium Medical College
Role Name Email Phone Street address
Scientific Enquiries Delayehu Bekele delayehu@gmail.com +251922743743 Swaziland street
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia Associate Professor of Obstetrics and Gynecology, Saint Paul's Hospital Millennium Medical College
REPORTING
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