A clinical trial to study the effects of two drugs, Dinoprostone gel and tablet Misoprostol in pregnant women who are planned for induction of labour
- Conditions
- Health Condition 1: O759- Complication of labor and delivery, unspecified
- Registration Number
- CTRI/2020/04/024809
- Lead Sponsor
- Theishingla Mashangva
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Modified BISHOP score at recruitment less than or equal to 6
2) Gestational age more than or equal to 37 weeks to 42 weeks
3) Live fetus
4) Singleton pregnancy
5) Cephalic presentation
6) Indication for IOL( IUGR, hypertensive disorders of pregnancy, gestational diabetes mellitus, etcetera)
1) Preterm IOL
2) Multifetal gestations
3) Non- cephalic presentations
4) Previous uterine scar and rupture
5) Premature rupture of membranes ( PROM)
6) Antepartum heamorrhage
7) Fetal anomalies
8) Active genital herpes
9) Pelvic structural deformities associated with cephalopelvic disproportion
10) Invasive cervical carcinoma
11) Previous pelvic surgeries like trachelorrhaphy, vesicovaginal fistula / rectovaginal fistula/ pelvic floor repair ( third or fourth degree perineal tears repair)
12) Patients wishing for elective CS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the induction to delivery interval between PGE2 ( intracervical Dinoprostone gel 0.5 mg 2 doses 6 hours apart) and PGE1( per vaginal Misoprostol tablet 25 mcg 6 hourly maximum 4 doses) with or without oxytocin for IOL( Induction of Labour)Timepoint: 2020-2022
- Secondary Outcome Measures
Name Time Method 1. To compare the maternal and fetal outcomes between the two groups <br/ ><br>2. To compare the pre-induction of labour transvaginal scan (IOL-TVS) cervical length predictability in the outcome of induction of labourTimepoint: 2020-2022