Induction of labor in women with unfavorable cervix: A randomised controlled study to assess the effectiveness of intracervical foley’s catheter with extra amniotic saline infusion vs only foley’s catheter

All the pregnant woman including both primigravida and multigravida who have been admitted for induction of labor with  no other contraindication for vaginal delivery will be assessed by their pre induction BISHOPS score

Women with score < 6 will be taken into study after satisfying all the inclusion and exclusion criteria and after taking a detailed history and written informed consent. (10)

Under strict aseptic precautions 22F foleys catheter will be inserted into cervix under direct visualization by holding the tip of the catheter with an artery forceps , bulb of  the foleys catheter will be inflated with 20cc normal saline and the catheter will be gently pulled back so as to assure the tip of the catheter is beyond internal os and bulb is exactly at the level of internal os.

Once the position of the catheter is confirmed the bulb will be further inflated with 40 cc of normal saline, a total of 60 cc of normal saline will be used for foley bulb inflation.

 Once the foley bulb is inflated,500cc warm normal saline(0.9% isotonic normal saline at room temperature) will be infused at the rate of 60cc/hr into the extra amniotic space through the catheter port via an infusion pump and back flow of the saline will be prevented by knotting the catheter at the rear end at the end of infusion.

Then the catheter will be tied to the medial side of the thigh after creating the necessary traction.

After spontaneous expulsion of foley’s catheter or after removal of foleys catheter after 24 hours of insertion, Post induction BISHOP’S score will be assessed and further methods of induction like PGE2 gel/ misoprostol/oxytocin will be decided based on the score.

Only the guide/ co guide will do the pre and post induction BISHOPS scoring

Patient blinding cannot be done. But the assessor ( guide/co-guide) will be blinded. Pre and post induction BISHOP will be assessed by the same person.

Pharmacological agents will be used if post foleys bishops score still indicates an unfavorable cervix i.e., if the score is still ≤6, prostaglandins will be considered. If the score is ≥7 , oxytocin will be given for further induction(11)

Induction - delivery interval, mode of delivery (normal vaginal delivery/ instrumental delivery/ c section), maternal and neonatal complications will be noted.