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.: PACTR201702002017237 Date of Approval: 03/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cervical Ripening
Official scientific title Postpartum vaginal blood loss following two different methods of cervical ripening
Brief summary describing the background and objectives of the trial BACK GROUND: Induction of labor is a common procedure, and it remains an obstetric challenge. The outcome of induction of labor and its various determinants are paramount in a setting where women are prone to chronic anemia in pregnancy and the adverse effects of heavy blood loss following child birth. OBJECTIVES: The study was designed to determine the postpartum outcome of two different methods of cervical ripening for induction of labor, which are currently being used in the hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Induction of labor,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2014
Actual trial start date 30/04/2014
Anticipated date of last follow up 01/05/2014
Actual Last follow-up date 01/05/2014
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL not yet published
Secondary Ids Issuing authority/Trial register
Health Research and Ethics Committee of UCTH UCTH/HREC/33/104
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 randomization using a randomization table created by a computer software program sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaginal misoprostol 50 microgram 6 hourly to a maximum of 4 doses under 24 hours prospective 40
Control Group Foley Catheter Single insertion 12 hours prospective 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
37 completed weeks up to 41 completed weeks plus 3 days Bishop score of <5 a live singleton fetus with cephalic presentation at term intact membranes with no evidence of labor no contraindications to a vaginal delivery up to the third parity history of uterine scar twins breech presentation fetal anomalies antepartum hemorrhage polyhydramnios presence of uterine fibroids in pregnancy known allergy to prostaglandin preparations women with anemia (defined as hemoglobin level less than 10.5g/dl or a hematocrit of less than 31%) bleeding disorders pelvic abnormalities/deformities 18 Year(s) 48 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 07/10/2013 Health Research and Ethics Committee of UCTH, Calabar
Ethics Committee Address
Street address City Postal code Country
Unical Hotel road off Etagbo road Calabar Municipality 540001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postpartum vaginal blood loss from crowning of the fetal head (second stage of labor) up to 6 hours post delivery
Secondary Outcome induction delivery interval from start of intervention to time of child birth
Secondary Outcome Apgar score score at 1 minute and 5 minute post delivery
Secondary Outcome neonatal cord blood pH at time of cord clamping following delivery of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UCTH (University of Calabar Teaching Hospital) Unical Hotel road off Etagbo road Calabar Municipality 540001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Researcher / Investigator 8 Stream road, 8 miles Calabar Municipality 540001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Okon A Okon 8 Stream road, 8 miles Calabar Municipality 540001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Ekabua E John Unical Hotel road off Etagbo road Calabar Municipality 540001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Okon Okon konie9ja@gmail.com +2348035909334 8 Stream road, 8 miles
City Postal code Country Position/Affiliation
Calabar Municipality 540001 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries John Ekabua johnekabua@yahoo.com +2348053359121 82 Victory Way, Satellite town
City Postal code Country Position/Affiliation
Calabar municipality 540001 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Okon Okon konie9ja@gmail.com +2348035909334 8 Stream road, 8 miles
City Postal code Country Position/Affiliation
Calabar municipality 540001 Nigeria consultant
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