A clinical study to compare the combined efficacy of mechanical and pharmacological methods versus pharmacological method alone when used for induction of labor.
- Conditions
- Labor induction in pregnancy
- Registration Number
- CTRI/2012/12/003265
- Brief Summary
Induction of labor is an intervention that artificially initiates uterine contractions leading to the progressive effacement and dilatation of cervix leading to the birth of the baby. It is a common procedure done in obstetric practice when the risks of continuing pregnancy are more, hence a decision is taken to deliver. The goal of induction is to eliminate the potential risks to fetus with prolonged intrauterine existence while minimizing the likelihood of an operative delivery. It can be done by various pharmacological and mechanical methods.
Foley catheter acts by overstretching the lower uterine segment and cervix; this releases prostaglandins to cause softening of cervix. Misoprostol stimulates the myometrium resulting in uterine contractions.
Our hypothesis for this study was that a combination of a mechanical agent i.e. Foley catheter with a pharmacological agent i.e. low dose intravaginal misoprostol would be a better method of induction than use of misoprostol alone as it would cause cervical ripening and uterine contractions simultaneously.
As they have a different mechanisms of action, it may be postulated that a higher success rate of vaginal delivery and a lower rate of side effects and complications like uterine hyperstimulation can be achieved by combining both Foley catheter and misoprostol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 126
Singleton pregnancy corresponding to gestational age of 28 weeks or more Intact membranes Absence of labor Cephalic presentation Bishop score 4 or less Volunteering to participate.
Multifetal gestation Lethal fetal anomaly Gravida 5 or more Non-reassuring FHR tracings Ruptured membranes Previous uterine surgery Low lying placenta Active genital infection Chorioamnionitis Previous induction during the pregnancy Intrauterine fetal death Estimated fetal weight more than 4000gm Thyrotoxicosis, heart disease, bronchial asthma, Sickle cell disease, glaucoma Unwillingness to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Induction to delivery interval N/A Rate of vaginal delivery N/A
- Secondary Outcome Measures
Name Time Method Uterine tachysystole Uterine hyperstimulation
Trial Locations
- Locations (1)
Department of Obstetrics
🇮🇳Hyderabad, ANDHRA PRADESH, India
Department of Obstetrics🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDr Sreelakshmi LankaPrincipal investigator040-40222447srilulanka@yahoo.com