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 eeffort and to correct dystocia with the 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.³

2. 
   Review of Literature
   

In a study done by zhang, et al, in 2011, involving 15,054 women from 6 hospital who received oxytocin (stating dose and incremental dosing of 1,2, and4 mu/min) for augmentation of labour.Study conclude 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 outcomes¹.

Cochrane review done by Mori et al, from the four RCT involving 660 pregnant women requiring labour augmentation by oxytocin comparing high and low dose.The results showed reduction in length of labour and caesarean section and no significant difference for neonatal mortality, hyperstimulation and APGAR scores²

In a Systematic review of ten RCT, the studies contrasting 2 intervention for labour augmentation: high dose Vs low dose oxytocin done by Shu-Qin wei et al. The results suggest moderate decrease in caesarean section rate and labour duration and increase in spontaneous vaginal delivery. While hyper stimulation was increased with high dose, there was no evidence of increase in maternal or neonatal morbidity³.

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 Jamal et al, involving 200 pregnant women, who received high dose or low dose oxytocin protocol for augmentation of labour. The study concluded- high dose oxytocin is associated with significantly shorter labour without any adverse fetal and maternal outcome⁵.

In a RCT done by Tabovei et al, involving 448 nulliparous women, who received high or low dose oxytocin for augmentation of labour.The study showed active management with high dose oxytocin is associated with shortened labour, decreased caesarean section there were no significant difference in maternal and neonatal morbidity between two groups⁶.

In a RCT done by Merrill et al, high dose compared with low dose oxytocin for augmentation and induction of labour. Study showed high dose oxytocin is associated with significantly shorter labours without any demonstrable Fetal or neonatal effects⁷.

In a RCT done by Rebecca and George [1997], involving 405 nulliparous women, who received either high or low dose oxytocin for active management of labour. High dose oxytocin had shortened labour duration, reduced caesarean section. Maternal and fetal outcomes did not vary significantly between 2 groups⁸

In a RCT done by Elly and Xenakis 310 term pregnancies who received either high dose or low dose oxytocin augmentation regimen.Study showed lower caesarean section rate regardless of parity with no difference in maternal complications and neonatal outcome⁹

In a RCT done by Adrew et al involving 2788 pregnancies requiring augmentation of labour, either with high or low dose oxytocin. Result showed significantly fewer caesarean section and forceps delivery with high dose oxytocin. Although high dose oxytocin was associated with utrine hyper stimulation, no adverse fetal outcome were observed¹⁰.

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 groups¹¹.

1. 
   Objectives of the Study:
   

1. 
   To determine the efficacy and safety of high dose versus low dose oxytocin in the augmentation of labour.
   
2. 
   Maternal and fetal outcome.
   
3. 
   To reduce duration of labour.
   

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 -31^st dec2013

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
  
• 
  Hydromnios / oliguhydramnios
  

• 
  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 mortality
  

Duration of labour

Caesarean section rate

• 
  Secondary outcome – Assisted vaginal delivery
  

Incidence of uterine rupture

APGAR score

NICU admissions

• 
  Follow up - nil
  
• 
  Follow up period- not required
  

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. 
   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 obstetrics and gynecology August 2011; 118 (Issue 2: Part 1): 249-256.
   

2. 
   Mori R, Tokumasu H, Pledge D, Kanyan S. High dose Versus low dose oxytocin for augmentation of delayed labour cochrane Data bar of systematic Reviews 2011; Issue 10: Arl No: CDOO720.
   

3. 
   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. American Journal of Obstetria and Gynecology October 2010;203[4]:296-304.
   

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. Amj Obstet Gynecol 1997; 177: 599-605.
   

9. 
   Frigoleto FD, Liebernas E, Lary JM et al. A clinical trial of active management of labour. N Engl J Med 1995; 333: 745-50.
   

10. 
    Lopez-Zen JA, Peacoman AM, Adashek JA, Socol Ml. A Controlled trial of a program for the active manangemet of labour. N. Engl J Med 1992; 326: 450-4.
    

11. 
    Bidgood KA, Steer PJ. A randomized control study of oxytocin augmentation of labour and Obstetric outcome. Br J Obstet Gynaecol 1987; 94: 512-7.