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.: PACTR202305683057580 Date of Approval: 05/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vaginal douching with acetic acid versus normal saline prior to pre-induction cervical ripening with intravaginal misoprostol among nulliparous women at term: A randomized study
Official scientific title Vaginal douching with acetic acid versus normal saline prior to pre-induction cervical ripening with intravaginal misoprostol among nulliparous women at term: A randomized study
Brief summary describing the background and objectives of the trial This is a randomized controlled study that will be carried out at Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, south-eastern Nigeria. Eligible pregnant nulliparous women with obstetrics indications for cervical ripening and labour induction will be recruited for the study via the antenatal clinic and labour ward. Relevant biodata and clinical details will be obtained and recorded in a proforma. After initial evaluation and pre-induction cardiotocography, the participants will be randomised into two arms (in a 1:1 ratio, with blocks of four): acetic acid vaginal douching arm and normal saline vaginal douching arm. The baseline vaginal pH measurement and Bishop score will be recorded, vaginal douching performed with appropriate solution. The resulting vaginal pH will be measured and recorded. Misoprostol 50mcg will be inserted intravaginally. The participants will be evaluated every 6 hours to determine if the cervix is ripe or favourable (defined by Bishop score 6 and above) or the need for repeat intravaginal misoprostol. A maximum of 4 doses of misoprostol will be used for each participant in this study. If the cervix is not ripe or active phase of labour is not achieved after the fourth dose of misoprostol, the process is adjudged to have failed. The time taken to achieve ripe cervix, active phase of labour and vaginal delivery will be recorded. The participants and the researcher will be blinded to the agent used for vaginal douching. The primary outcome will include the mean time from administration of intravaginal misoprostol to favourable cervix and active phase of labour. The induction-to-delivery interval, the proportion of pregnant women that required oxytocin, and the proportion of neonates with birth asphyxia (Apgar scores less than 7 in 1 minute) in each group are some of the secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VaDAACI
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied CERVICAL RIPENING AND INDUCTION OF LABOUR
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2023
Actual trial start date
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 170
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline 20ml 60 seconds vaginal douching 85 Placebo
Experimental Group 5 percent acetic acid 20ml 60 seconds vaginal douching 85
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Term (37 to 42weeks) singleton pregnancy Nulliparity Cephalic presenting fetus No drainage of liqour No contraindication to vaginal delivery Preterm pregnancy Intra uterine fetal death Cephalopelvic disproportion Fetal abnormal lie Fetal abnormal presentation Multiple pregnancy Previous caesarean scar or uterine surgeries Preinduction fetal heart rate abnormalities Present history of antepartum haemorrhage Adult: 19 Year-44 Year 18 Year(s) 49 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 18/01/2023 NAUTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
No 49 Nnewi Onitsha Road Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean time from administration of intravaginal misoprostol to active phase of labour. The time interval from administration of intravaginal misoprostol to diagnosis of active phase of labour.
Secondary Outcome Mean total doses of misoprostol administered for preinduction cervical ripening in each group Proportion of women that had need for oxytocin induction The mean time from administration of intravaginal misoprostol to vaginal delivery (induction-delivery interval). Proportion of neonates with birth asphyxia (Apgar score less than 7 in 1 minute) in each group. The time interval from administration of intravaginal misoprostol to vaginal delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWICHI NNEWI Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OKAFOR CHIDIMMA DONATUS NAUTH, Nnewi Nnewi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OKAFOR CHIDIMMA DONATUS NAUTH, Nnewi Nnewi Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
ELEJE GEORGE UCHENNA NAUTH, Nnewi NNEWI Nigeria
OKPALA BONIFACE NAUTH, Nnewi NNEWI Nigeria
OKAFOR CHIDIMMA FAVOUR NAUTH, Nnewi NNEWI Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHIDIMMA OKAFOR favourspecialist@gmail.com +2347069099217 NAUTH, Nnewi
City Postal code Country Position/Affiliation
NNEWI Nigeria PRINCIPAL INVESTIGATOR
Role Name Email Phone Street address
Public Enquiries CHIDIMMA OKAFOR favourspecialist2020@gmail.com +2347069099217 NAUTH,Nnewi
City Postal code Country Position/Affiliation
NNEWI Nigeria Public Enquiries
Role Name Email Phone Street address
Scientific Enquiries CHIDIMMA OKAFOR favourspecialist2020@gmail.com +2347069099217 NAUTH, Nnewi
City Postal code Country Position/Affiliation
NNEWI Nigeria Scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial, after de-identificaton Study Protocol Immediately following publication, no end date beginning 3months and ending 5 years Not applicable
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