comparison of Dilapan S versus foleys balloon for preinduction cervical ripening- A randomized control trial

The study will be done in Sri Manakula Vinayagar Medical College and Hospital under the

department of Obstetrics and Gynaecology after approval of institutional ethics and research

committee. The study will be registered in clinical Trials Registry India.

Patient will be explained about the nature of the study and after obtaining written informed valid

consent, patients will be enrolled in study patients who meet the inclusion criteria. Patient data will

be recorded in the proforma. Details regarding age, sex, contact information, weight, detailed

history and examination, per speculum and per vaginal examination, haemoglobin, routine urine

examination, cardiotocography, ultrasound for assessing presentation, amniotic fluid index,

estimated foetal weight and co-morbidities will be recorded.

Based on randomization sequence, patients will be allocated into two groups: group A and group B.

Group A patients will have Dilapan S (hygroscopic osmotic dilator) for induction of labor. Group

B patients will have Foley’s balloon for induction of labor. Prior to induction of cervical ripening

women belonging to both the groups will undergo cardiotocography.

Group A - Dilapan S, (rod size – 4 x 65 mm) will be inserted intracervically in women belonging to

group A. The cervix will be visualised with a sterile vaginal speculum and rods will be inserted

into cervical canal under direct visualization. Patient will be instructed to report any excessive

bleeding, pain or other symptoms and not to remove the rods by herself. The dilators will be left in

place for atleast 24 hrs.

Group B – Foley’s balloon will be inserted intracervically in women belonging to group B. The

cervix is visualised using sterile vaginal speculum. The Foley’s balloon tip will be introduced past

the internal cervical os and filled with 50 ml of sterile water. The free end of the Foley catheter will

be taped to the patient’s thigh and kept under tension. It will be left in place for atleast 24 hrs.

After removal of Dilapan S or Foleys, the Bishop’s score will be reassessed. For those with

unfavourable cervix, cerviprime gel 0.5 mg will be applied intracervically every 6 hours to a

maximum of 3 doses. At any point of time in the induction of labour, if Bishops score of ≥ 6 is

achieved, induction will be continued with oxytocin infusion with 5 Units in 500 ml normal saline

based on contractions. Initially, the infusion is started at a rate of 8 drops/ minute, followed by

gradual titration till adequate contraction is achieved. Adequate contraction is defined as 3 to 5

contractions in 10 minutes, each lasting for 40 – 60 seconds.

Once the patient enters into the active phase of labor, she will be started on a liquid diet. Pain

scoring will be assessed with Visual Analogue Scale (VAS) every 6 hours from pre-induction

cervical ripening till delivery. Labor will be monitored using WHO-modified partogram. Uterine

contractions will be monitored every 30 min and Foetal heart rate will be monitored every 15min

with intermittent auscultation. Maternal vitals (temperature/ pulse rate/blood pressure/respiratory

rate will be monitored every 1 hour.