A clinical trial evaluating labor induction in pregnant women with simultaneous versus sequential use of trans-cervical (inserted in cervix) foley catheter and misoprostol
- Conditions
- Health Condition 1: O610- Failed medical induction of labor
- Registration Number
- CTRI/2023/11/059372
- Lead Sponsor
- Free Maternity Services Government of India under National Health Mission
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All nulliparous women with unfavorable cervix (Bishop score <6) planned for IOL. Inclusion criteria will be ; age 18 to 40 years and singleton-term pregnancy (=38 weeks).
spontaneous labor; Bishop score =6; fetal malpresentation; non-reassuring fetal heart rate; any previous uterine surgery (CD/hysterotomy, myomectomy, or metroplasty); multifetal gestation; antepartum hemorrhage; intrauterine fetal demise; rupture of membranes; placenta previa or vasa previa, or cord presentation; active genital herpes; severe pre-eclampsia, GDM on pharmacological treatment
any contraindication to vaginal delivery; allergy to latex; any contraindication to prostaglandins; any medical illness such as asthma, cardiac disease, known bleeding disorder, concurrent anticoagulant therapy, pelvic infection, any comorbid surgical illness (eg, nephrolithiasis, cholelithiasis); or any previous attempt of IOL in the present pregnancy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Induction delivery intervalTimepoint: after delivery of the baby (variable period as per duration of labor)
- Secondary Outcome Measures
Name Time Method maternal & neonatal morbidityTimepoint: after delivery of the baby (as per duration of labor);mode of deliveryTimepoint: after delivery of the baby (as per duration of labor);number of doses of vaginal misoprostol requiredTimepoint: after delivery of the baby (as per duration of labor);duration of the latent phase of laborTimepoint: after delivery of the baby (as per duration of labor)