NCT04200599

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

December 11, 2019

Last Update Submit

December 12, 2019

Conditions

Delivery DelayedMode of DeliveryPost Partum HemorrhageUterine Hyperstimulation

Keywords

primigravidaamniotomy,immediate oxytocindelayed oxytocin

Outcome Measures

Primary Outcomes (2)

  • Achieving vaginal delivery

    number of normal vaginal delivery

    through study completion, an average of 18 months

  • Neonatal outcome

    Apgar score

    through study completion, an average of 18 months

Study Arms (2)

Early oxytocin Infusion

EXPERIMENTAL

labour augmentation with oxytocin was started early following amniotomy.

Other: duration of initiation of oxytocin

Late oxytocin infusion

ACTIVE COMPARATOR

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

Interventions

duration of initiation of oxytocinOTHER

mode of delivery

Early oxytocin InfusionLate oxytocin infusion

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall primigravida
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Betran 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. doi: 10.1111/j.1365-3016.2007.00786.x.

    PMID: 17302638RESULT

  • 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.

    PMID: 21646928RESULT

  • O'Driscoll K, Jackson RJ, Gallagher JT. Prevention of prolonged labour. Br Med J. 1969 May 24;2(5655):477-80. doi: 10.1136/bmj.2.5655.477.

    PMID: 5771578RESULT

  • Dencker A, Berg M, Bergqvist L, Ladfors L, Thorsen 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.

    PMID: 19250364RESULT

  • 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: 10.1111/j.1471-0528.2008.01819.x.

    PMID: 18715415RESULT

  • 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):813-20. doi: 10.1007/s00404-008-0818-x. Epub 2008 Oct 29.

    PMID: 18958483RESULT

  • 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):641-649. doi: 10.1097/AOG.0b013e3181b11cb8.

    PMID: 19701046RESULT

  • 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;2013(6):CD007123. doi: 10.1002/14651858.CD007123.pub3.

    PMID: 23794255RESULT

  • 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):253-259. doi: 10.1097/AOG.0b013e31827e7fd9.

    PMID: 23344273RESULT

  • 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. No abstract available.

    PMID: 25472418RESULT

  • 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.

    PMID: 29680082RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad azrai abu

    Department of Obstetrics and Gynecology, UKM Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Consultant

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

August 1, 2014

Primary Completion

January 30, 2016

Study Completion

March 31, 2016

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share