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.: PACTR201411000920150 Date of Approval: 28/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title managment of oligohydramnios
Official scientific title Sildenafil Citrate Therapy for Oligohydramnios
Brief summary describing the background and objectives of the trial The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of AFI measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will remain Sildenafil-naïve.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied oligohydramnios
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2014
Actual trial start date 01/11/2014
Anticipated date of last follow up 30/04/2015
Actual Last follow-up date 30/04/2015
Anticipated target sample size (number of participants) 184
Actual target sample size (number of participants) 184
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly allocated into two groups according to a trial sequence determined via a computer generated random table. The trial sequence is hidden into opaque sequenced envelopes as each envelope contains an assignment for a single patient. Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sildenafil citrate 25mg every 8 hours till delivery follow up of amount of liquor 93
Control Group Fluid therapy 250 ml isotonic saline IV 4 hours 91 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women will be included if they are of any age, any parity, carrying a singleton pregnancy, at a gestational age (GA) 30 weeks or more (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography), they have an AFI ¿ 5, no pregnancy complications such as preeclampsia, gestational hypertension, or diabetes, no prior history of kidney, lung, and heart disease (the use of bolus-fluid therapy is contraindicated in these patients), and intact fetal membranes. Mothers treated with prostaglandin synthetase inhibitors, well established labor, evidence of fetal distress (non-reactive non stress test), or fetal complications (intrauterine growth retardation or obvious fetal anomalies) are considered exclusion criteria. 18 Year(s) 45 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 14/10/2014 menoufiya university ethics commitee
Ethics Committee Address
Street address City Postal code Country
gamal abdelnaser shebin elkom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the values of AFI before and after therapy in each group and between both groups. time after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufiya university gamal abdelnasser shebin elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya university hospital gamal abdelnaser shebin elkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya university hospital gamal abdelnaser shebin elkom Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed maher um sarar khamis mushyat Saudi Arabia
Tarek Mohammad Sayyed gamal abdelnaser shebin elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Maher mohamaher2010@yahoo.com +966558198655 um sarar
City Postal code Country Position/Affiliation
khamis mushyat Saudi Arabia consultant and assisstant professor
Role Name Email Phone Street address
Principal Investigator tarek sayyed tareksayed70@yahoo.com 00201222739097 gamal abdelnaser
City Postal code Country Position/Affiliation
shebin elkom Egypt assisstant professor
Role Name Email Phone Street address
Principal Investigator Nabih Elkholy drnabih33@yahoo.com 00201060868443 gamal abdelnaser
City Postal code Country Position/Affiliation
shebin elkom Egypt lecturer
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