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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: www.pactr.org

Trial no.: PACTR201211000447393 Date registered: 2012/10/30
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
Purpose of the trial Treatment
Anticipated trial start date 2012-09-04
Actual trial start date 2012-10-10
Anticipated date of last follow up 2013-08-08
Actual date of last follow up
Anticipated target sample size (number of participants) 110   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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)

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
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 Min age Max 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 Years 33 Years 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 2012/07/02 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 Fax
Principal Investigator Dr Tarek Sayyed tareksayed70@yahoo.com 002 01222739097
Street address City Postal code Country Position / Affiliation
Mostafa Al-Nahhas Street Cairo Egypt Lecturer in Obstetrics and Gynecology at Menoufiya University.
Role Name Email Phone Fax
Principal Investigator Prof Mohamed Kandeel kandeelcando@yahoo.com 002 01005784043
Street address City Postal code Country Position / Affiliation
Madenat Al-dobat Street Cairo Egypt Professor of Obstetrics and Gynecology at Menoufiya University
Role Name Email Phone Fax
Public Enquiries Dr Alaa Masoud Alaa_masoud75@hotmail.com 002 01001545759
Street address City Postal code Country Position / Affiliation
Adly street Shebeen Al-Koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)
Role Name Email Phone Fax
Scientific Enquiries Dr Mohamed Emara mohemarh@yahoo.com 002 01000649994
Street address City Postal code Country Position / Affiliation
Omar afandi Street Shebeen Al-koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)
Role Name Email Phone Fax
Principal Investigator Dr Alaa Masoud Alaa_masoud75@hotmail.com 002 01001545759
Street address City Postal code Country Position / Affiliation
Adly Street Shebeen Al-Koum Egypt Lecturer in Obstetrics and Gynecology (Menoufiya University)