Brief resume of the intended work

1. 
   Need for the study:
   

Recent reports suggest that high caesarean rates may have an adverse impact on maternal and neonatal morbidity and mortality. Dystocia is the leading indication

for primary caesarean section. Inadequate uterine activity has been described as the most frequent cause of dystocia. Augmentation of labour with oxytocin is a frequent intervention in modern obstetric practice. When labour fails to progress, oxytocin is administered to augment contractile effort and to correct dystocia with an objective on achieving a normal vaginal delivery. Oxytocin has been demonstrated to increase the frequency and intensity of uterine contractions when spontaneous uterine contraction is inadequate and the progress of labour is slow. Oxytocin protocols can be categorized as high-dose or low-dose protocols depending on the initial dose and the amount and rate of sequential increases. Despite the frequency with which oxytocin is used in clinical practice, there is little consensus regarding the optimal dose of oxytocin for labour augmentation.¹
The ideal dose at which it should be given is not known, although some comparisons suggest that higher doses of oxytocin could shorten labour and reduce the chance of caesarean section with an increase in the numbers of women having a spontaneous vaginal birth compared with a lower dose. However, there are potentially harmful side effects if oxytocin causes the uterus to contract too quickly, and the baby becomes distressed.²

2. 
   Review of Literature
   

In a study done by Zhang, et al, in 2011, involving 15,054 women from 6 hospitals who received oxytocin (stating dose and incremental dosing of 1,2, and 4 (mu/min) for augmentation of labour. Study concludes high dose oxytocin regimen is associated with a shorter duration of first stage of labour for all parities without increasing the caesarean delivery rate or adversely affecting perinatal outcomes³.

In

In a study done by Patka, et al, included clinical trials comparing high versus low-dose ocytocin for augmentation labour.High dose oxytocin for augmentation of labour, showed decrease duration of labour but does not appear to decrease caesarean section rates⁴.

In a RCT done by Bid good and Steer, involving 60 women why who were progress slowly in spontaneous labour were assigned to 3 management protocol (No oxytocin, low dose oxytocin, High dose oxytocin). Significant decrease in delay to delivery duration with high dose protocol. There were no measurable difference in newborn condition between 3 groups¹⁰.

1. 
   Objectives of the Study:
   

1. 
   To compare the effect of high and low dose oxytocin on augmentation of labour.
   
2. 
   To study maternal and fetal morbidity and mortality.
   

1. 
   Source of Data:
   

Study place-K.V.G.Medical College & Hospital,Sullia

Study design-prospective study

Sample design-block randomisation.

Period of study-1^st Dec 2012 -30^th Nov 2013

2. 
   Method of collection of data (including sampling procedures if any):
   

• 
  Primi/multi gravida (< 6)
  
• 
  Singleton pregnancy
  
• 
  Term gestation (> 37 wks)
  
• 
  Cephalic presentation
  
• 
  Normal fetal heart rate
  
• 
  No medical complications
  
• 
  In spontaneous labour
  
• 
  Requiring augmentation of labour
  

• 
  Multiple pregnancy
  
• 
  Cephalopelvic disproportion (CPD), contracted pelvis
  
• 
  Mal-presentation
  
• 
  History of previous caesarean section
  
• 
  Antepartal haemorrhage [placenta previa, abruption placentae ]
  
• 
  Meconium stained liquor
  
• 
  Hydroamnios / oligohydramnios
  

• 
  PROM(premature rupture of membrane)
  

120 women in labour assessed as requiring augmentation will be randomized for following intervention (high or low dose oxytocin regimen).

• 
  High dose - defined as starting dose and increment of equal to or more than 4 mu/min ,incremental dose of 4mu/min
  
• 
  Low dose - defined as starting dose of less than 4mu/min, incremental dose of 1-2mu/min
  
• 
  Increase interval – every 20 minutes
  

• 
  Primary outcome – Perinatal morbidity and mortality
  

Caesarean section rate

• 
  Secondary outcome – Assisted vaginal delivery
  

Incidence of uterine rupture

APGAR score

NICU admissions

• 
  Follow up – Yes
  
• 
  Follow up period- 7 days
  

3. 
   Does the Study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
   

• 
  Hb%
  
• 
  Urine for sugar, albumin, microscopy.
  
• 
  Blood grouping and Rh typing
  
• 
  HIV
  
• 
  HBs Ag.
  
• 
  VDRL
  
• 
  OGCT
  
• 
  PARTOGRAM
  
• 
  NST
  
• 
  USG
  

• 
  Per vaginal examination
  
• 
  Augmentation with low dose/high dose oxytocin
  
• 
  Normal labour with episiotomy
  
• 
  Forceps delivery
  
• 
  Ventouse delivery
  
• 
  Caesarean section
  

4. 
   Has ethical clearance been obtained from your institution in case of 7.3?
   

1. 
   Shu-Qin Wei, Zhong-Chang Luo, Hui-Ping Q, Hairong Xu, William O Fraser. High dose V/s low dose oxytocin for labour augmentation: A Systematic review. Am J Obstet Gynecol 2010;203[4]:296-304.
   

2. 
   Mori R, Tokumasu H, Pledge D, Kanyan S. High dose Versus low dose oxytocin for augmentation of delayed labour. cochrane Database of Systematic Reviews 2011, Issue 10. Art. No.: CD007201.
   

3. 
   Zhang, Jun, Branch, D, Ware, Ramirez, Mildred M., Laughon S. Katherine, Reddy, Uma, Haffman, Mathew, Bailit, Jennifer. Oxytocin. Regimen for Labour Augmentation, Labour progressions, and perinatal outcomes. Obstet Gynecol 2011; 118 (Issue 2: Part 1): 249-256.
   

4. 
   Patka JH, Lodolce AE, Johnston AK. High versus low dose oxytocin for augmentation or induction of labour. ; The Ann Pharmacother 2005 Jan;39(1): 95-101.
   

5. 
   Jamal A, Kalantari R. High and low dose oxytocin in augmentation of labour. Int J Gynacol Obstet 2004; 87: 6-8.
   

6. 
   Tabower TO, Oborovo. Active Management of labour in district hospital setting. J Obstet Gynaecol 2003; 23; 9-12.
   

7. 
   Merrill DC, Zlatnik FJ. Randomised double marked comparison of oxytocin dosage in induction and augmentation of labour. Obstet Gynecol 1999; 94: 455-63.
   

8. 
   Rogere R, Gilson GJ, Millor AC, Izquierdo LE, Curet LB, Qualli CR. Active Management of labour. Does it make a differences. Am J Obstet Gynecol 1997; 177: 599-605.
   

9. 
   Elly M. J. Xenakis, Oded Langer, Jenna M piper, Deborah Conway, Micheal D Berkin. Low dose versus high dose oxytocin for augmentation of labour-randomised trial. Am J Obstet Gynecol 173 (6):1874-1878, Dec 1995.
   

10. 
    Bidgood KA, Steer PJ. A randomized control study of oxytocin augmentation of labour and Obstetric outcome. Br J Obstet Gynaecol 1987; 94: 512-7.