A Randomized controlled Trial of PGE2 gel vs Transcervical Foleys Catheter for Induction of Labor in Women with Previous Cesarean Section

Repeat cesarean section exposes women to multiple risks like blood loss, injury to the urinary tract, infections, adherent placenta, and cesarean hysterectomy. Vaginal birth after cesarean section is a procedure that can be offered to women who have had a prior cesarean section.

Induction of labor is often taken up in the interest of the mother and the fetus. Labor induction in the presence of an unfavorable cervix is associated with labor dystocia and a higher incidence of repeat cesarean section. Hence, the use of cervical ripening agents is beneficial. Induction with Foley catheter is a safe, inexpensive, and reliable method of cervical ripening, with a low risk of uterine tachysystole and fetal distress but poses a potential danger of accidental rupture of membranes, cord prolapse, chorioamnionitis, and pyrexia because of infection.5 While PGE 2 gel  has also been proven to be effective for cervical ripening agents with a gradual onset of labor with the advantage of single application. Many studies that have evaluated cervical ripening with prostaglandin E2 (PGE2) insert have shown conflicting results and in the absence of conclusive studies, many countries continue to use PGE2 for induction of labor.

Intracervical Foley catheter has been proven efficient in achieving cervical ripening and successful labor with reduction in latent phase of labor and total delivery time without increasing the rate of cesarean section, uterine tachysystole, and uterine rupture. Considering the good performance of maternal and neonatal outcomes, the intracervical Foley catheter has been suggested  as a better choice for preinduction cervical ripening and induction of labor in women with previous cesarean sections in resource-limited settings.

   Therefore, we decided to conduct a Randomized controlled trial   at the setting of AIIMS Jodhpur to compare the effectiveness and safety profile of PGE2 gel  with intracervical Foley’s catheter for ripening of cervix and induction of labor in women with previous 1 lower segment cesarean section

Sample size has been calculated to be62 patients (with31 patients in each group) considering alpha of 0.05 ,90% power and 20% attrition rate. Patients will be selected as per inclusion and exclusion criteria and preinduction  workup will done followed by enrollment and consent .  Group 1 and Group 2 will continue to be compared even after achieving  of primary objective of study (difference in change of Bishop score between PGE2 gel and Foleys catheter ).   Various parameters like Bishop score , presence of fetal distress , induction to delivery interval , mode of delivery , Apgar score will be noted and compared between the two methods of induction of labor .    All the results will be evaluated statistically and whether any significant difference present or not will be noted. The entire study will be performed   as per  the ethical guidelines and monitoring and treatment will be  done as per standard hospital policy .