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.: PACTR201908560004686 Date of Registration: 05/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title esomeprazole in pre-eclampsia
Official scientific title Efficacy of esomeprazole in the management of early preeclampsia.
Brief summary describing the background and objectives of the trial Preeclampsia is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in urine. The condition begins after 20 weeks of pregnancy. In severe disease there may be red blood cell breakdown, a low blood platelet count and impaired liver function. Preeclampsia cause more than 60,000 maternal deaths annually. As preeclampsia occurs at preterm gestations, clinicians are often forced to do early delivery of pregnancy to prevent major maternal morbidity, but this will lead to prematurity of fetus. Inparticular, fetuses delivered at less than 33 weeks gestation are at significant risk of severe disability including chronic lung diseases and death. The only treatment option available to arrest the disease is delivery of the pregnancy. If a safe treatment was available that could stop the disease progression of preeclampsia, clinicians could delay the delivery and gain gestation to improve fetal outcome, and this could save the lives of many infants. The aim of this study is to evaluate the efficacy of Esomperazole in management of early preeclampsia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied pre-eclampsia
Purpose of the trial Prevention
Anticipated trial start date 01/12/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 01/12/2018
Actual Last follow-up date 01/12/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 160
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group received esomeprazole 40 mg esomeprazole orally daily from the time of diagnosis of early onset pre-eclampsia till termination of pregnency they received 40 mg esomeprazole orally daily till the the time of delivery in addition to the expectant management 80
Control Group expectant management only placebo from the diagnosis of early onset pre-eclampsia till the termination of pregnancy from the diagnosis of early onset pre-eclampsia till the termination of pregnancy expectant management, which included antihypertensive drugs, iron and calcium supplementation. 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A diagnosis of one of the following: -preeclampsia. -Gestational hypertension with evidence of preeclampsia. -Unclassified proteinuric hypertension. And all of the following is present: -Gestational age between 26+0 and 31+6 weeks. -Singleton pregnancy. -Estimated fetal weight by ultrasound between 500 And1800g (if gestation not certain). -No suspicions of a major fetal anomaly or malformation. -Patient is unable or unwilling to give consent. -The presence of eclampsia. -Severe hypertension. -Established fetal compromise that necessitates delivery. -Cardiovascular events. -Contraindication or hypersensitivity to the use of esomeprazole. -Current use of a drug that may be affected by a proton pump inhibitor. -Elevated liver enzymes. -Low platelets count. -Liver hematoma. -Left-sided heart failure. -Severe ascites. -Pulmonary edema. Adult: 18 Year(s)-44 Year(s) 19 Year(s) 44 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 05/11/2017 research ethics committee faculty of medicine suez canl univerity
Ethics Committee Address
Street address City Postal code Country
ring road ismailia, egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the success of esomeprazole in prolongation of gestation measured from the time of enrolment to the time of delivery, in hours and days in women diagnosed with early onset preeclampsia. at the time of termination of pregnancy
Secondary Outcome ● To determine whether esomeprazole can improve maternal, fetal and neonatal outcomes in early onset pre-eclampsia being managed expectantly compared to expectant management alone. ● To examine whether 40 mg of daily esomeprazole is safe and well tolerated in the mother and infantor not. at the time of termination of pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university faculty of medicine ring road, kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mahmoud mohamed elshaer ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty pf medicine suez canal university ring road, kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Zakia Mahdy abolill ring road kilo 4.5 ismailia Egypt
khaled Ahmed Atwa ring road kilo 4.5 ismailia Egypt
Ahmed AbdElmonem Abo Elroos ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Principal Investigator zakia abolill zakiamahdyabolill@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing data will be through the recommendations of our ethics committee Study Protocol at the end of the trial through the ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.dropbox.com/s/vswh84hzshayujr/DOC-20190726-WA0000.docx?dl=0 Yes Age in both groups was comparable, with the mean age of control group 30.60 ± 1.59 years in control group and 30.68 ± 1.66 years in interventional group (p=0.52). Moreover, there was no significant difference between the two groups in the parity categories (p=0.24). It was found that patients who administered esomeprazole had significantly lower incidence of fits episodes than those who did not receive it (p=0.005). On the other hand, no maternal death was reported in both groups. Systolic and diastolic blood pressure had reported lower values in patients who took esomeprazole compared to their counterparts who did not receive it (p<0.001). Moreover, patients who administered esomeprazole had significantly lower umbilical artery resistance index (0.63 ± 0.09) than those who did not receive it (0.71 ± 0.09) (p=0.005). On the other hand, patients in esomeprazole group had significantly lower incidence of antepartum hemorrhage (p=0.005) and Disseminated intravascular coagulation (p=0.032). No intracranial hemorrhage was reported in both groups. 26/07/2019 26/07/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/vswh84hzshayujr/DOC-20190726-WA0000.docx?dl=0
Changes to trial information