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.: PACTR202008475715326 Date of Approval: 24/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF ANTENATAL ANTIHELMINTHIC TREATMENT ON PREGNANCY OUTCOMES IN UITH ILORIN: A RANDOMISED CONTROLLED TRIAL.
Official scientific title EFFECTS OF ANTENATAL ANTIHELMINTHIC TREATMENT ON PREGNANCY OUTCOMES IN UITH ILORIN: A RANDOMISED CONTROLLED TRIAL.
Brief summary describing the background and objectives of the trial Background Helminthic infestations are very common in our pregnant women and have been implicated as a cause of anaemia in pregnancy. Routine antenatal deworming has been recommended but is yet to be integrated into our antenatal care protocol in this facility. Objective The main objective of this study shall be to determine the effect of albendazole on intestinal parasite prevalence and compare it to placebo in pregnant women at the University of Ilorin Teaching Hospital. The effects on maternal anaemia and neonatal birth weight shall also be assessed. Materials and Methods This study shall be a randomised controlled trial in pregnant women at the antenatal clinic of university of Ilorin Teaching Hospital. All pregnant women that satisfy the inclusion criteria and give consent will be recruited until the proposed sample size is complete. Stool samples will be obtained for stool analysis and baseline packed cell volume will be determined. Eighty eight units of 400mg of albendazole capsules and 88units of empty capsules(placebo) will be randomly labelled with computer generated random numbers from 1 to 176. The drugs will be rearranged in ascending order and recruited patients will be assigned to the drugs successively without skipping. They will be followed up in the antenatal clinic according to the departmental protocol and monthly supply of haematinics (60mg elemental iron daily) will be given to them. Adherence will be checked at each visit by counting the number of capsules left over. At 36 weeks, packed cell volume and maternal stool microscopy will be determined. They will be monitored until delivery to determine other pregnancy outcomes. The primary outcome measure will be the maternal stool parasite density. Secondary outcome measures will include maternal anaemia, neonatal birth weight, APGAR scores, NICU admission and still birth. These outcomes will be compared between the study groups. The level of significance will be set at 0.05 at 95% confidence interval.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Helminthiasis
Purpose of the trial Prevention
Anticipated trial start date 06/05/2020
Actual trial start date 30/04/2020
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date 12/01/2021
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 176
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
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 envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Albendazole 400mg Statum dose Two caplets of 200mg of albendazole are given to pregnant women between 14 and 26 weeks gestation 88
Control Group Empty caplets Statum dose Two empty caplet resembling albendazole given to pregnant women between 14 and 26weeks gestation 88 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All consenting pregnant women with singleton foetus presenting between 14 and 26 weeks. • Non consenting pregnant women. • Patients with known hypersensitivity to benzimidazole. • Baseline haemoglobin concentration less than 7g/dl. • Patients with multiple gestations. • Patients with sickle cell disease • Patients with chronic kidney disease. • Retroviral disease patients. • Patients that may require blood transfusion during the course of pregnancy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 26/03/2019 University of Ilorin Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Oke-Ose Ilorin 240003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome The secondary outcomes will be determined by maternal anaemia and neonatal birth weight, APGAR scores NICU admission and still birth. At delivery
Primary Outcome Maternal stool parasite density At 36 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital. Oke-Ose Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Olabinjo Afusat 8, Etsu Ndakpoto Street Basin Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Afusat Olabinjo Department of Obstetrics and Gynaecology. University of Ilorin Teaching Hospital Ilorin Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr H.A Raji Associate Professor of Obstetrics and Gynaecology, University of Ilorin/UITH Ilorin Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afusat Olabinjo hafsoh.ola@gmail.com +2348062164990 No 8, Etsu Ndakpoto street, Basin
City Postal code Country Position/Affiliation
Ilorin Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Peter Aboyeji abidunpeter@yahoo.co.uk +2348033814792 Department of Obstetrics and Gynaecology, University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Hadijat Raji laideraji@yahoo.com +23433940387 Department of Obstetrics and Gynaecology, Uith
City Postal code Country Position/Affiliation
Ilorin Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to present this data to the West Africa College of Surgeons Informed Consent Form,Statistical Analysis Plan Data will be submitted within a year of completion of study Data will be shared with the Hospital Ethical Committee
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