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.: PACTR201902599405211 Date of Approval: 12/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long acting penicillin use in pregnant females with history of unexplained prelabor rupture of membranes
Official scientific title Long acting penicillin use in pregnant females with history of unexplained prelabor rupture of membranes
Brief summary describing the background and objectives of the trial Premature rupture of membranes (PROM) refers to rupture of the fetal membranes prior to the onset of labor, at any gestational age and is associated with an increased risk of ascending infection. Infection and inflammation likely explains why membranes break earlier than they are supposed to. In some studies, bacteria have been found in the amniotic fluid in about one-third of cases of PROM. Even if testing of the amniotic fluid is normal, a subclinical infection may still be contributing. In response to infection, the body creates inflammation by making chemicals (ex: cytokines) that weaken the fetal membranes and put them at risk for rupture . The fetal membranes serve as a barrier to ascending infection. Once the membranes rupture, both the mother and fetus are at risk of infection and of other complications. Fetal risk is related primarily to the gestational age. Preterm PROM is associated with a 4- fold increase in perinatal mortality and a 3-fold increase in neonatal morbidity, including respiratory distress syndrome, poly microbial intra-amniotic infection, intraventricular hemorrhage, and neonatal deaths . Long acting penicillin as a broad spectrum antibiotic could protect against bacterial colonization that may predispose to infection. Our aim is to evaluate the effect of Long acting penicillin use in pregnant females with history of unexplained prelabor rupture of membranes as a prophylaxis against bacterial colonization and recurrent prelabor rupture of membranes
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Unexplained prelabor rupture of membranes
Purpose of the trial Prevention
Anticipated trial start date 15/02/2019
Actual trial start date 15/02/2019
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Penicillin 1,200000 IU/month 9 months I.M injection 50
Control Group Placebo 9 months No treatment 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant females, with history of unexplained prelabor rupture of membranes Any disease associated with pregnancy Adult: 19 Year-44 Year 20 Year(s) 35 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 27/12/2018 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Mesalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Premature Rupture of Membranes PMRM All through pregnancy
Secondary Outcome Bacterial colonisation Every month for till 36 weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynecology Faculty of Medicine University of Alexandria 12 PortSaid Street ElShatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Abdelfattah 514 Elhoryaa Road Elwezara Bolkely Alexandria 21531 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynecology Faculty of Medicine University of Alexandria 12 PortSaid Street ElShatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tarek Karkoor 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Tamer Abd El Dayem 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Eman Abdelfattah El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Amany Ismaiel El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Amr Mohsen El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Doaa Omar El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abd El Daiem tmdaiem@yahoo.com 00201226720766 12 PortSaid Street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Obstetrics and Gynaecology Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Eman Abdelfattah Eman0eman0eman7@gmail.com 00201284374180 514 Elhoryaa Road Elwezara Bolkely
City Postal code Country Position/Affiliation
Alexandria 21531 Egypt Assistant Professor of Obstetrics and Gynaecology Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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