To compare Oral Mifepristone with Foley catheter for softening of cervix in women planned for delivery at or after 39 weeks of pregnancy
- Conditions
- Pregnant women
- Registration Number
- CTRI/2021/07/034943
- Lead Sponsor
- JIPMER INTRAMURAL
- Brief Summary
Induction of labour is the most common obstetric procedure performed worldwide with an incidence of 25%.Success of labour induction depends on cervical “ripeness†or “favorabilityâ€.
Various pharmacological and mechanical methods are available for cervical ripening and induction of labor. Prostaglandin analogues like Dinoprostone(PGE2) and Misoprostol (PGE1) in various formulations are found to be more effective than Oxytocin,but are associated with the risk of uterine hyperstimulation, fetal distress and uterine rupture. Mechanical methods such asFoleycatheter and hygroscopic dilators are associated with decreased risk of uterine hyperstimulation but increased maternal and neonatal infectious morbidity.
Progesterone antagonist like Mifepristone has been extensively used for termination of pregnancy in 1st and 2nd trimester and term intrauterine fetal demise. It binds to progesterone receptor and blocks the action of progesterone at the cellular level thereby decreasing the myometrial quiescence state and increasing its sensitivity to uterotonic agents.
Several studies have shown that Mifepristone is a safe and effective way to ripen the cervix thereby inducing the labour process in term pregnancies with no adverse maternal or fetal events.There are no studies comparing the efficacy of Mifepristone with trans-cervical Foley catheter for pre-induction cervical ripening in term and late term pregnancy.
If this study results show better or comparable effect of Mifepristone as pre-induction ripening agent to Foley catheter, then it can be used in outpatient basis for cervical ripeningthereby decreasing hospital stay with less infectious morbidity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 266
- Age ≥ 18 years 2.
- Period of gestation: 39 to 42 weeks 3.
- Singleton live fetus with cephalic presentation with reactive Non-stress Test 4.
- Bishop’s score ≤6 5.
- Intact membranes 6.
- Planned for induction of labour 7.
- Unscarred uterus.
- 1.Absolute contraindications for vaginal delivery 2.Patient requiring imminent delivery 3.
- Evidence of chorioamnionitis 4.Patients with known contraindications to Mifepristone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine and compare the change in Bishop score with oral Mifepristone versus trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening Bishop score will be reassessed at 24 hours and 48 hours after administration of Tablet Mifepristone
- Secondary Outcome Measures
Name Time Method To determine and compare the efficacy and safety of oral Mifepristone with trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening
Trial Locations
- Locations (1)
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
JIPMER🇮🇳Pondicherry, PONDICHERRY, IndiaDr T ParvathiPrincipal investigator9566537193parvathinaik1@gmail.com