Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

Post Partum Hemorrhage Clinical Trial

Official title:

Amniotomy and Early Oxytocin Infusion Versus Amniotomy and Delayed Oxytocin Infusion in Nulliparous Women: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200599
• Other study ID #: PPI/111/8/JEP-2015-022
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: March 31, 2016

Study information

• Verified date: December 2019
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In UKM Medical Centre (UKMMC), delayed oxytocin augmentation at two hours following amniotomy is the routine obstetric practice in spontaneous or induced labour with intact membranes. This practice may potentially cause prolonged labour, extended labour room occupancy and increased maternal exhaustion while no additional benefit can be gained. On the other hand, recommendation for early oxytocin augmentation poses a dilemma as the effectiveness and safety of this practice are still in doubt.

Given this background, the aim of this study was to compare the effect of early versus delay oxytocin infusion in achieving successful vaginal delivery among the low-risk nulliparous women in UKMMC. Besides, this study also compares the adverse maternal and neonatal outcomes between the two practices.

Description:

This was a randomised controlled trial undertaken in the labour room of UKMMC for a period of eighteen months from August 2014 until February 2016. Eligible women who were admitted in spontaneous labour or for induction of labour were recruited. For women who underwent induction of labour, an interval of at least six hours following vaginal prostaglandin before recruitment was mandatory to avoid overlapping effect of prostaglandin and oxytocin. Upon enrolment, each patient was given a study explanation and written consent was obtained.

The randomisation sequence, either to the early oxytocin group or the delayed oxytocin group, was generated using the computer randomisation program in block of two. Allocation to either arm of treatment was determined by the sequential opening of sealed numbered envelopes.

In the first arm of early oxytocin group, labour augmentation with oxytocin was started early following artificial ruptured of membrane(ARM). In the second arm of delayed oxytocin group, oxytocin augmentation was delayed at two hours after ARM and this practice is currently being used as standard protocol in this hospital to manage women in labour. In both arms,the infusion rate was doubled every 30 minutes to a maximum of 48 mL/h or until four to five moderate contractions per 10 minutes were achieved at which point the infusion rate was maintained. Continuous fetal heart rate monitoring was maintained throughout the intrapartum period. Vaginal examination was performed at four hours after ARM as well as when clinically indicated ie. abnormal cardiotocography (CTG) and maternal desire to bear down. In the presence of abnormal CTG, either fetal blood sampling or expedited delivery was undertaken as per decided by the obstetrician in charge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2016
• Est. primary completion date: January 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• gestational age between 36+0 to 41+6 weeks

• singleton pregnancies in cephalic presentation

• estimated fetal weight between 2.5 - 4.0 kg

• cervical dilatation of 4 cm with intact membranes

• normal fetal heart rate trace before artificial rupture of membranes

Exclusion Criteria:

• Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease)

• fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)

Related Conditions & MeSH terms

• Delivery Delayed
• Hemorrhage
• Mode of Delivery
• Post Partum Hemorrhage
• Postpartum Hemorrhage
• Uterine Hyperstimulation

Intervention

Other:
• duration of initiation of oxytocin
mode of delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

References & Publications (11)

Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65. — View Citation

Betrán AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. — View Citation

Bugg GJ, Siddiqui F, Thornton JG. Oxytocin versus no treatment or delayed treatment for slow progress in the first stage of spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 23;(6):CD007123. doi: 10.1002/14651858.CD007123.pub3. Review. — View Citation

Delgado Nunes V, Gholitabar M, Sims JM, Bewley S; Guideline Development Group. Intrapartum care of healthy women and their babies: summary of updated NICE guidance. BMJ. 2014 Dec 3;349:g6886. doi: 10.1136/bmj.g6886. — View Citation

Dencker A, Berg M, Bergqvist L, Ladfors L, Thorsén LS, Lilja H. Early versus delayed oxytocin augmentation in nulliparous women with prolonged labour--a randomised controlled trial. BJOG. 2009 Mar;116(4):530-6. doi: 10.1111/j.1471-0528.2008.01962.x. — View Citation

Hinshaw K, Simpson S, Cummings S, Hildreth A, Thornton J. A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women. BJOG. 2008 Sep;115(10):1289-95; discussion 1295-6. doi: 10.11 — View Citation

Liston R, Sawchuck D, Young D. No. 197a-Fetal Health Surveillance: Antepartum Consensus Guideline. J Obstet Gynaecol Can. 2018 Apr;40(4):e251-e271. doi: 10.1016/j.jogc.2018.02.007. — View Citation

O'Driscoll K, Jackson RJ, Gallagher JT. Prevention of prolonged labour. Br Med J. 1969 May 24;2(5655):477-80. — View Citation

Selo-Ojeme DO, Pisal P, Lawal O, Rogers C, Shah A, Sinha S. A randomised controlled trial of amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin infusion for induction of labour at term. Arch Gynecol Obstet. 2009 Jun;279(6):813 — View Citation

Tan PC, Soe MZ, Sulaiman S, Omar SZ. Immediate compared with delayed oxytocin after amniotomy labor induction in parous women: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):253-9. doi: http://10.1097/AOG.0b013e31827e7fd9. — View Citation

Wei SQ, Luo ZC, Xu H, Fraser WD. The effect of early oxytocin augmentation in labor: a meta-analysis. Obstet Gynecol. 2009 Sep;114(3):641-9. doi: 10.1097/AOG.0b013e3181b11cb8. Review. Erratum in: Obstet Gynecol. 2010 Jul;116(1):196. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving vaginal delivery	number of normal vaginal delivery	through study completion, an average of 18 months
Primary	Neonatal outcome	Apgar score	through study completion, an average of 18 months