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.: PACTR202305754076736 Date of Approval: 30/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of vaginal wash with 3% acetic acid on the efficacy of vaginal misoprostol for labour induction at term at Federal Medical Centre, Abeokuta
Official scientific title The Effect of vaginal wash with 3% acetic acid on the efficacy of vaginal misoprostol for labour induction at term at Federal Medical Centre, Abeokuta
Brief summary describing the background and objectives of the trial Background Maternal and child health issues are among the top public health concerns globally. Inducing labour and improving the outcomes of labour in those women for whom spontaneous labour is not imminent is an integral part of obstetric management efforts. A broad range of mechanical and pharmacological methods have been used to induce labour such as insertion of balloon catheters, laminaria tent, dilapan, membrane stripping, and application of prostaglandins (PGE1, PGE2, PGF2α), oxytocic, nitric oxide donors, mifepristone. Misoprostol is economical, widely available, stable at room temperature, and has few side effects which makes it suitable for induction of labour in all clinical settings. Misoprostol has been shown to have dual effect of ripening the cervix and inducing labour, however, it is fraught with unpredictable actions and effects on patients in achieving successful labour induction. Few studies have assessed the effect of local vaginal factors on the efficacy of vaginal misoprostol for cervical ripening and induction of labour in term pregnancies. Aim The aim of the study is to determine the effect of increasing vaginal acidity with 3% acetic acid vaginal wash on the efficacy of vaginal misoprostol for induction of labour in term singleton pregnancies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/03/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Vaginal wash with Normal saline solution before induction of labour 6 hourly 24 hour Prior to intervention, a speculum examination will be performed by the researcher or the trained research assistants, with Cusco’s speculum and vaginal pH value will be measured with a pH indicator paper. The indicator paper will be held with artery forceps on the lateral fornix for 15 seconds using a non-touch technique. Colour change of the strip will immediately be compared with the colorimetric scale and the measurement will be recorded. For patients that have pH≥ 5, Whiff test will be done to rule out bacterial vaginosis. A cotton swab stick will be used to take sample from the vaginal wall and the speculum will then, be removed. The vaginal sample will be smeared on a glass slide and a drop of 10% Potassium hydroxide (KOH) will be added to the smear using a disposable plastic pipette. The vapour layer above the surface of the slide will be fanned and assessed for the presence of volatile amines which have a fishy odour. A presumptive diagnosis of bacterial vaginosis will be made in patients in whom such is present, and they will be excluded from the study. A digital vaginal examination will then be performed to have an initial cervical assessment of the women using the modified Bishop score. Vaginal wash will be done with sterile gauze wrapped on a sponge holding forceps, soaked, and dripping with Normal saline solution in the control group. This will be done twice. Five minutes after washing the second time, the pH of the vagina will be rechecked using the same technique described above. Fifty micrograms of Misoprostol61 (A quarter of a 200 micrograms tablet of Cytotec; G.D. Searle & Co., UK, divided with a tablet cutter to ensure even division) will then be inserted into the posterior vaginal fornix. The same product will be used for all the participants. This process will be repeated, with the exclusion of pH check, at an interval of 6 hours between each dose in control group, up to a maximum of four doses 48 Active-Treatment of Control Group
Experimental Group vaginal wash with acetic acid solution before induction of labour 6 hourly 24 hour Prior to intervention, a speculum examination will be performed, by the researcher or the trained research assistants, with Cusco’s speculum and vaginal pH value will be measured with a pH indicator paper. The indicator paper will be held with artery forceps on the lateral fornix for 15 seconds using a non-touch technique. Colour change of the strip will immediately be compared with the colorimetric scale and the measurement will be recorded. For patients that have pH≥ 5, Whiff test will be done to rule out bacterial vaginosis. A cotton swab stick will be used to take sample from the vaginal wall and the speculum will then, be removed. The vaginal sample will be smeared on a glass slide and a drop of 10% Potassium hydroxide (KOH) will be added to the smear using a disposable plastic pipette. The vapour layer above the surface of the slide will be fanned and assessed for the presence of volatile amines which have a fishy odour. A presumptive diagnosis of bacterial vaginosis will be made in patients in whom such is present, and they will be excluded from the study. A digital vaginal examination will then be performed to have an initial cervical assessment of the women using the modified Bishop score. Vaginal wash will be done with sterile gauze wrapped on a sponge holding forceps, soaked, and dripping with 3% acetic acid solution in the intervention group. This will be done twice. Five minutes after washing the second time, the pH of the vagina will be rechecked using the same technique described above. Fifty micrograms of Misoprostol61 (A quarter of a 200 micrograms tablet of Cytotec; G.D. Searle & Co., UK, divided with a tablet cutter to ensure even division) will then be inserted into the posterior vaginal fornix. The same product will be used for all the participants. This process will be repeated, with the exclusion of pH check, at an interval of 6 hours between each dose up to a maximum of four doses 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women who have consented to participate in the study • singleton pregnancy • cephalic presentation • term gestation (defined as ≥37 weeks) • Normal fetal heart rate on cardiotocography • Bishop score of ≤5 • Allergy to misoprostol • Multiple pregnancies • Gestational age < 37 weeks • Malpresentation • Estimated fetal weight of >4000 gm • Ruptured membranes • Non-reassuring cardiotocography • ≥Para 4 • Nonconsenting women • Fetal anomaly and fetal demise • Previous uterine surgery • Abnormal vaginal discharge • Patients with vaginal pH ≥ 5 with positive Whiff test 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 11/09/2022 Federal Medical Centre Abeokuta Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Olabisi Onabanjo Way, Idi-Aba Ogun state 3031 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Induction to delivery interval at delivery of Baby
Secondary Outcome Interval Interval between induction and active phase of labour The total dose of vaginal misoprostol that will achieve cervical ripening and induction of labour The caesarean section rate, including the indication and outcome of the caesarean section The occurrence of any feto-maternal complications Interval between induction and active phase of labour The total dose of vaginal misoprostol that will achieve cervical ripening and induction of labour The caesarean section rate, including the indication and outcome of the caesarean section The occurrence of any feto-maternal complications between induction and delivery of Baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Abeokuta Olabisi Onabanjo Way, Idi-Aba Ogun state 3031 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
NIMOTALLAH OJUGBELE Olabisi Onabanjo Way, Idi-Aba Ogun state 3031 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NIMOTALLAH OJUGBELE Olabisi Onabanjo Way, Idi-Aba Ogun state 3031 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries NIMOTALLAH OJUGBELE mnimah008@gmail.com +2349097220269 Olabisi Onabanjo Way, Idi-Aba .
City Postal code Country Position/Affiliation
Ogun state 3031 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Principal Investigator NIMOTALLAH OJUGBELE mnimah008@gmail.com +2349055600073 Olabisi Onabanjo Way, Idi-Aba
City Postal code Country Position/Affiliation
Ogun state 3031 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries NIMOTALLAH OJUGBELE mnimah008@gmail.com +2349097220269 Olabisi Onabanjo Way, Idi-Aba
City Postal code Country Position/Affiliation
Ogun state 3031 Nigeria SENIOR REGISTRAR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date Any purpose
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