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 - Trial PACTR202305683057580

Timeline & Enrollment

Summary

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.

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