Is oral tablet misoprostol more effective and safer than injectible drug oxytocin in pregnant women at term whose membranes ruptured before the onset of labour pains.
- Conditions
- Pregnant women at term with prelabour rupture of membranes
- Registration Number
- CTRI/2016/02/006637
- Lead Sponsor
- Dept of Obstetrics and Gynaecology Christian Medical College and Hospital
- Brief Summary
This is a prospective randomized controlled unmasked trial which will be done in pregnant women at term with pre-labour rupture of membranes. Active or planned management in pre-labour rupture of membranes redues maternal infectious morbidity and neonatal care unit admission when compared to expectant management [1]. There are different methods of induction of labour for pre-labour rupture of membranes. In this study we are comparing oral misoprostol to intravenous oxytocin for induction of labour. Research done in this institution [2] on term inductions without rupture of membranes has shown that women in the group that received oral misoprostol were more likely to develop uterine contractions without oxytocin than women given vaginal misoprostol. Thus due to ease of administration especially in women with rupture of membranes ,we deciced to use oral misopostol. Women in the arm randomized to oxytocin will be induced with usual oxytocin protocol followed in labour room for induction of labour. Women randomized to oral misoprostol will be given oral misoprostol 50mcg at four hourly inteval maximum of three doses in primi gravida and two doses in multi gravida.These women then be induced with oxytocin after twelve hours of first dose of oral misoprostol if they do not have uterine contractions.After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever ,CTG abnormalities, neonatal morbidity etc, will be collected. The data collected will be analysed to compare safety and efficacy in both groups. BIBLIOGRAPHY:
1.Dare MR, Middleton P, Crowther CA, Flendy FJ, Varatharaju B. Planned early birth vresus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more).Cochrane Database Syst rev 2006 jan 25;(1):CD005302.
2. A radomized double mask placebo controlled trial comparing oral misoprostol with vaginal misoprostol for induction of labour. Dr.HIlda Yenuberi, Dr.Anuja Abraham, Dr.Ajit Sabastian, Dr.SAnthosh Joseph Benjamin,Dr.Visalakshi Jayasheelan, Dr.Jiji Elizebeth Mathew Awaiting Publication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 200
•Pregnancies between 37 – 41 weeks of gestation with singleton foetus with vertex presentation •Reassuring fetal heart rate •Definite diagnosis of PROM.
- Contraindications to vaginal delivery -Previous uterine scar -Diagnosis of labour -Meconium stained liquor -Clinical estimated fetal weight > 4 kgs -Evidence of chorioamnionitis, temperature > 100.4 degree Fahrenheit, uterine tenderness or foul smelling amniotic fluid.
- Any severe medical disease like diabetes on insulin or severe pre-eclampsia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Duration between induction and delivery Difference of 2 hours from induction to delivery. 5% difference in LSCS rates -Vaginal delivery achieved within 24 hours Difference of 2 hours from induction to delivery. 5% difference in LSCS rates -Caesarean section Difference of 2 hours from induction to delivery. 5% difference in LSCS rates
- Secondary Outcome Measures
Name Time Method -Need for oxytocin augmentation -Serious neonatal morbidity or perinatal death eg sepsis,seizures,birth asphyxia,neonatal encephalopathy-Serious maternal morbidity or death eg sepsis,admission to ICU,septicaemia,traumatic PPH-Fever, chorioamnionitis, endometritis-Apgar score less than seven at five minutes-Neonatal intensive care unit admission-Maternal nausea-Maternal diarrhea-Other maternal side-effects-PPH more than500ml of blood loss -Woman and Caregiver not satisfied Soon after delivery.
Trial Locations
- Locations (1)
Department of obstetrics and gynaecology
🇮🇳Vellore, TAMIL NADU, India
Department of obstetrics and gynaecology🇮🇳Vellore, TAMIL NADU, IndiaDr Shiny Nirupama BodduPrincipal investigator7094910812nirupamashiny@yahoo.co.in