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.: PACTR201505001094636 Date of Approval: 02/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study of blood sugar levels in pregnant women on progesterone therapy for prevention of preterm labour versus control group
Official scientific title Study of blood sugar levels in pregnant women on progesterone therapy for prevention of preterm labour versus control group
Brief summary describing the background and objectives of the trial Progesterone pessary is becoming a commonly used medication for prevention of preterm labour in high risk patients until 34 weeks gestation. Progesterone affects glucose metabolism inhibits glucose uptake by affecting diverse steps of insulin signaling in 3T3-L1 adipocytes. Furthermore, pregnancy is known to be a diabetogenic status due to several hormones produced by the placenta to maintain adequate glucose levels in maternal blood for transfer to the fetus.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Gestational diabetes,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/05/2015
Actual trial start date
Anticipated date of last follow up 02/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group administration of progesterone vaginal pessary for prevention of preterm labour in high risk women 200 milligram twice daily from 14th till 34th week of gestation administration of vaginal progesterone pessary 150
Control Group none none 14th-34th weeks of gestation none 150 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Singleton pregnancy. 2- Gestational age 14-34weeks 3-BMI less than 35 1-Pre-gestational diabetes. 2-Patients with history of gestational diabetes in previous pregnancies. 18 Year(s) 40 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 faculty of medicine-Alexandria university
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine street, RamlStation Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome develpoment of gestational diabetes 24 and 34 weeks of gestation
Secondary Outcome fetal outcome at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby Maternity university hospital Army Road, Next to library of Alexandria Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tamer Mamdouh AbdelDayem 8 faculty of medicine street, Raml station Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
Primary Sponsor Shatby Maternity university hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamer Mamdouh AbdelDayem 8 faculty of medicine street, Raml station Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandria University
Role Name Email Phone Street address
Public Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandriaq University
Role Name Email Phone Street address
Scientific Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandriaq University
REPORTING
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Result URL Hyperlinks
Changes to trial information