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Delivery DelayedNCT04200599

Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

A study testing duration of initiation of oxytocin in people with Delivery Delayed and Mode of Delivery, run by National University of Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
duration of initiation of oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
1 Aug 2014to 31 Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

Official title: 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.

Read the 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.

Being tested
duration of initiation of oxytocin
Keywords
primigravida, amniotomy,, immediate oxytocin, delayed oxytocin
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • duration of initiation of oxytocinOther

    mode of delivery

Study groups in NCT04200599
Study groupRoleWhat they receive
Early oxytocin InfusionExperimentallabour augmentation with oxytocin was started early following amniotomy.
Receives: Other: duration of initiation of oxytocin
Late oxytocin infusionActive comparatoroxytocin 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.
Receives: Other: duration of initiation of oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achieving vaginal delivery

    number of normal vaginal delivery

    Measured: through study completion, an average of 18 months

  2. Neonatal outcome

    Apgar score

    Measured: through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start1 Aug 2014
  3. Primary completion30 Jan 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200599
Sponsor's protocol ID
PPI/111/8/JEP-2015-022
Status last verified
Dec 2019
First submitted
11 Dec 2019
Last updated
16 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17302638

  • 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.

    PubMed 21646928

  • 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.

    PubMed 5771578

  • 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.

    PubMed 19250364

  • 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.

    PubMed 18715415

  • 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.

    PubMed 18958483

  • 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.

    PubMed 19701046

  • 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.

    PubMed 23794255

  • 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.

    PubMed 23344273

  • 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.

    PubMed 25472418

  • 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.

    PubMed 29680082

Questions about this trial

What is this clinical trial studying?

A study testing duration of initiation of oxytocin in people with Delivery Delayed and Mode of Delivery, run by National University of Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achieving vaginal delivery (time frame: through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04200599, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

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