Effect of breaking the bag of waters on the duration of spontaneous labour
- Conditions
- Pregnant women in spontaneous labour
- Registration Number
- CTRI/2014/12/005264
- Lead Sponsor
- Fluid Research Grant
- Brief Summary
Intentional artificial rupture of amniotic membranes is the most commonly performed procedure in modern obstetrics(1). It was first introduced by Thomas Denman, an English Obstetrician, in 1756. Mean length of first and second stage of labour was approximately 9 hours in nulli-parous women without regional analgesia and that the 95 percentile upper limit was 18.5 hours. The mean length of first and second stage of labour in multi- parous women without regional analgesia was 6 hours and that the 95 percentile upper limit was 13.5 hours.(2) The primary aim of amniotomy is to increase contractions and shorten the duration of labour.
With amniotomy, the production and release of local prostaglandins and oxytocin increase resulting in stronger contractions and quicker cervical dilatation. In some centers, it is routinely performed in all women and in many centers it is used for treatment of prolonged labour(1). Amniotomy allows detection of meconium stained liquor. With the active management of labour protocol introduced by O’Driscoll in 1993, the use of amniotomy has been widely accepted as part of labour. It is thought that when the membranes are ruptured, the production and release of prostaglandins and oxytocin contribute towards shortening labour (3). Others argue that the protective water is important for cervical dilatation. However, there are number of potential but rare risks associated with amniotomy like cord prolapse, fetal heart rate abnormalities and sepsis. The Randomized Controlled Studies included in the Cochrane review (1) that compared outcomes in women who had amniotomy with outcomes in women who did not have amniotomy had variable inclusion criteria and hence have conflicting results. Thus, a need for a well-designed large study to look at the outcomes of this intervention has been identified as a research priority.
1. Amniotomy for shortening spontaneous labor, Cochrane database of systematic reviews 2013, issue 6. Art.No: CD006167. DOI: 10.1002/14651858. CD006167 .pub4.
2. Kilpatrick SJ, laros RK Jr: Characteristics of normal labour Obstet Gynecol 74:85,1989
3. [Busowski JD](http://www.ncbi.nlm.nih.gov/pubmed?term=Busowski%20JD%5BAuthor%5D&cauthor=true&cauthor_uid=7554592)1, [Parsons MT](http://www.ncbi.nlm.nih.gov/pubmed?term=Parsons%20MT%5BAuthor%5D&cauthor=true&cauthor_uid=7554592). Amniotomy to induce labor. [Clin Obstet Gynecol.](http://www.ncbi.nlm.nih.gov/pubmed/7554592 "Clinical obstetrics and gynecology.") 1995 Jun;38(2):246-58.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 288
•Low risk patient •Singleton pregnancy •Vertex presentation •Membranes intact •Cervical dilatation from 3-5 cm •37 – 41 weeks •Spontaneous labour.
•Previous bad obstetric outcome •Gestational diabetes •Pre-eclampsia •IUGR •Previous LSCS •Previous Uterine surgery •HIV positive women •Para 4 and more •Presence of fetal heart abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Duration of labour One hour difference in duration of labour.
- Secondary Outcome Measures
Name Time Method 1. Caesarean Section 2. Need for oxytocin
Trial Locations
- Locations (1)
Labour ward, Department of Obstetrics and Gynaecology
🇮🇳Vellore, TAMIL NADU, India
Labour ward, Department of Obstetrics and Gynaecology🇮🇳Vellore, TAMIL NADU, IndiaDr MalarvizhiPrincipal investigator9894581716malarsbettu@cmcvellore.ac.in