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.: PACTR202208601005566 Date of Approval: 31/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of oral clindamycin and metronidazole in the treatment of Bacterial vaginosis in pregnant women attending antenatal clinic in the university of Uyo teaching hospital,Uyo, Akwa Ibom State,Nigeria.
Official scientific title Oral Clindamycin compared with metronidazole in the treatment of Bacterial vaginosis in pregnant women attending antenatal clinic in the university of Uyo teaching hospital,Uyo, Akwa Ibom State, Nigeria
Brief summary describing the background and objectives of the trial A randomized controlled trial to compare the efficacy of oral clindamycin and metronidazole in the treatment of bacterial vaginosis in pregnant women attending antenatal clinic. Study will be carried out on one hundred and thirty pregnant women diagnosed of BV using Nugent criteria, that will be randomized into two groups either group A that will receive oral clindamycin 300mg 8hourly for 7days or group B that will receive metronidazole 400mg 8hourly for 7days. Test for cure will be done 1week after the last dose then watch out for pregnancy outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ORACLIMB
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Bacterial vaginosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL Pubmed
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Clindamycin 300mg 8hourly 1week(7days) Women that were tested positive for BV using Nugent criteria and allocated group A and duly given consent were given an envelope containing drug A and advise on how to take and watch out for side effects. In case the notice any side effects the contact of the pharmacist was given to them to address their concerns. They were advised to return for a test for cure after treatment. Those that tested positive were excluded from the study while the negatives were followed up to delivery. 65
Control Group Oral metronidazole Group B 400mg 8hourly For 1week(7days) Women that tested positive to BV using Nugent criteria and duly signed the consent form that were allocated group B were given a drug envelope containing oral metronidazole and advised on how to take the drugs and the contact of the pharmacist given in case they experience an untoward effect. They were also told to come back for test of cure after 1.week of completion of treatment. Those positive after test of cure were removed from the study while they negatives were followed up till they delivered. 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Pregnant women attending antenatal clinic in University of Uyo teaching hospital UUTH after booking but before 32weeks GA, the GA determined from their last menstrual period or from an early ultrasound scan dating. 2) Pregnant women willing to give their informed consent. 3) Pregnant women with singleton pregnancies. 1) Any pregnant woman that refuses or withholds her consent to participate in the study. 2) contraindications or allergies to clindamycin or metronidazole. 3) Use of oral antibiotics or anti fungal agents concurrently, within the last 2.weeks 4) All pregnant women with known obstetrics and or medical complications that could be a precipitating factor for preterm labor or an indication for induction of labor prematurely. Adult: 19 Year-44 Year 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 21/06/2021 University of Uyo teaching hospital Uyo institutional health research ethical committee IHREC
Ethics Committee Address
Street address City Postal code Country
Abak road Uyo PMB1136 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Premature rupture of membranes is the spontaneous rupture of fetal membrane before the onset of labor. It can be at term or remote from term. During antenatal period or before onset of labour
Primary Outcome Preterm labour is the spontaneous onset of uterine contractions, descent of fetal presenting part and cervical changes before 37 weeks GA. Antenatal period and during labour
Primary Outcome Low birthweight refers to babies who weigh less Tran 2500grams at birth At point of delivery
Primary Outcome Late miscarriage or second trimester miscarriage refers to spontaneous termination of pregnancy that occurs after 12weeks of pregnancy but before age of fetal viability 28weeks Antenatal period
Primary Outcome Admission into the Neonatal intensive care unit for any indication After delivery
Secondary Outcome Maternal post operative complications if delivery was through Caesarean section From day 2 post operative period to discharge
Secondary Outcome Puerperal complications if delivery was through spontaneous vertex delivery From day 2.postpartum period to discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Uyo teaching hospital Abak road Uyo PMB 1136 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Otobong Peter Asuquo Abak road Uyo PMB 1136 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Otobong Peter Asuquo Abak road Uyo 1136 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Otobong Asuquo drotobong@gmail.com +2348039113059 Abak road
City Postal code Country Position/Affiliation
Uyo PMB 1136 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Oku Okoiseh drokoiseh@yahoo.com +2348061201864 Abak road
City Postal code Country Position/Affiliation
Uyo PMB 1136 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Ndianaobong Ekwere ndianaobonge@yahoo.com +2348025286331 Abak road
City Postal code Country Position/Affiliation
Uyo PMB 1136 Nigeria Assistant Director Laboratory Services
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in Bacterial vaginosis in pregnancy. Data or samples shared will be coded, with no PHI on included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted 9months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IDP can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data sharing Agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.Pubmed.com 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