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Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04200599
Enrollment
250
Registered
2019-12-16
Start date
2014-08-01
Completion date
2016-03-31
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Delayed, Mode of Delivery, Post Partum Hemorrhage, Uterine Hyperstimulation

Keywords

primigravida, amniotomy,, immediate oxytocin, delayed oxytocin

Brief 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.

Detailed 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.

Interventions

OTHERduration of initiation of oxytocin

mode of delivery

Sponsors

National University of Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Achieving vaginal deliverythrough study completion, an average of 18 monthsnumber of normal vaginal delivery
Neonatal outcomethrough study completion, an average of 18 monthsApgar score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026