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.: PACTR201211000447393 Date of Approval: 30/10/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Induction of labour in women with term premature rupture of membranes.
Official scientific title Oxytocin versus concurrent use of oxytocin and rectal misoprostol for induction of labour in women with term premature rupture of membranes:A randomised controlled trial
Brief summary describing the background and objectives of the trial Premature rupture of membranes puts a significant risk for pregnant women if it is not managed properly. This clinical trial aims to address the management of term premature rupture of membranes in pregnant women through comparison of two management protocols for induction of labour.The first protocol will be applied for the control group and includes the use of oxytocin for induction of labour meanwhile the second protocol will includes concurrent use of oxytocin and rectal misoprostol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Induction of labour in pregnant women with term premature rupture of membranes.,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/09/2012
Actual trial start date 10/10/2012
Anticipated date of last follow up 08/08/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
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 a random table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a random table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a random table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A 2mU/min of oxytocin infusion with increments by 2mU/min every 20 minutes to a maximum of 30mU/min 14 hours Induction of labour by oxytocin infusion alone in term pregnant women with premature rupture of membranes. 54 Active-Treatment of Control Group
Experimental Group Group B 50 microgram misoprostol tablets via rectal route every 4 hours for a maximum of three applications. 8-12 hours Women in group B will receive 50 microgram misoprotol rectally every 4 hours for a maximum of three applications and when Bishop score is 8 or no response after two doses, an oxytocin infusion will be started IV beginning with 2mU/min and then increased by 2mU/min every 20 minutes to a maximum of 30mU/min or until 3 contractions in 10 minutes are achieved. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed gestational age (32-42 weeks gestation)determined last menstrual period or by ultrasound scan in the 1st trimester. A singleton pregnancy with normal fetus in vertex presentation. Premature rupture of membranes confirmed by visualizing a pool of amniotic fluid at a sterile speculum examination and AFI less than 5. Absence of other indications for urgent induction of labor No signs of active labor, no abdominal pain on admission. Known hypersensitivity or any contraindications to prostaglandins (e.g.gluoma or sickle cell disease). Multiple pregnancy. Multiparity Contraindication to vaginal birth such as previous uterine surgery, contracted pelvis or malpresentation. Estimated fetal weight more than 4 kg or less than 2 kg Placenta previa or unexplained vaginal bleeding. Evidence of chorioamnionitis. Medical diseases e.g. cardiovascular disease or chronic renal failure. 19 Year(s) 33 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 02/07/2012 Menoufiya Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
University Street Shebin Al-Kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number of women who will succeed in delivering vaginally number of women who will succeed in delivering vaginally within 14 hours of initiation of the protocol in both groups
Secondary Outcome Incidence of excess uterine activity,labor induction to delivery interval, meconium stained liquor and mode of delivery Incidence of excess uterine activity during the first stage of labour. Induction to delivery interval including both first and second stage of labour. Meconium stained liquor during vaginal examination in first and second stage of labour Mode of delivery at the end of labour trial (Vaginal, instrumental or C.S.)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetric and Gynecology at Menoufiya University Hospitals University Street Shebin Al-Kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufiya University Hospitals University Street Shebin Al-Kom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetric and Gynecology University Street Shebin Al-kom Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Tarek Mohammad Sayyed Mostafa Al-Nahhas Street Cairo Egypt
Mohamed Ahmed Samy Kandee Madenat Al-dobat Street Cairo Egypt
Alaa Masoud Adly Street Shebeen Al-Koum Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Sayyed tareksayed70@yahoo.com 002 01222739097 Mostafa Al-Nahhas Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer in Obstetrics and Gynecology at Menoufiya University.
Role Name Email Phone Street address
Principal Investigator Mohamed Kandeel kandeelcando@yahoo.com 002 01005784043 Madenat Al-dobat Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Obstetrics and Gynecology at Menoufiya University
Role Name Email Phone Street address
Principal Investigator Alaa Masoud Alaa_masoud75@hotmail.com 002 01001545759 Adly Street
City Postal code Country Position/Affiliation
Shebeen Al-Koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)
Role Name Email Phone Street address
Public Enquiries Alaa Masoud Alaa_masoud75@hotmail.com 002 01001545759 Adly street
City Postal code Country Position/Affiliation
Shebeen Al-Koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)
Role Name Email Phone Street address
Scientific Enquiries Mohamed Emara mohemarh@yahoo.com 002 01000649994 Omar afandi Street
City Postal code Country Position/Affiliation
Shebeen Al-koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)
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