Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

December 12, 2019 updated by: Azrai Abu, National University of Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early oxytocin Infusion
labour augmentation with oxytocin was started early following amniotomy.
Other: duration of initiation of oxytocin
mode of delivery
Active Comparator: Late oxytocin infusion
oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.
Other: duration of initiation of oxytocin
mode of delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieving vaginal delivery
Time Frame: through study completion, an average of 18 months
number of normal vaginal delivery
through study completion, an average of 18 months
Neonatal outcome
Time Frame: through study completion, an average of 18 months
Apgar score
through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Muhammad azrai abu, Department Of Obstetrics And Gynecology, Ukm Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

January 30, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI/111/8/JEP-2015-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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