Birth; DelayedOxyHighLowNCT01587625
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour
A study testing Oxytocin in people with Birth; Delayed, run by Göteborg University at 2 sites in Sweden.
Trial summary
In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. Primary outcome is caesarean delivery rate. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Birth; Delayed
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,376 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2013to 8 Oct 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy nulliparous women
- singleton pregnancy
- normal pregnancy
- cephalic presentation
- spontaneous onset of active labour
- at term (37 - 42weeks gestation)
- delay or arrest of active labour
Who cannot join
- Non-Swedish speaking women
- previous uterine surgery
- intrauterine growth retardation > - 22%
- malpresentation at time of inclusion
- intrapartal hemorrhage at time of inclusion
- nonreassuring fetal-heart pattern at time of inclusion
- meconium at time of inclusion
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 41685
NU Hospital Group
Trollhättan
About this study
In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.
Read the detailed description
The aim is to compare starting dose and increment of amount of oxytocin for augmentation of delayed labour to determine whether augmentation by high dose of oxytocin improves labour outcomes compared with a low dose of oxytocin, without effecting neonatal outcomes or birth experiences negatively.
Delay in labour, also described as poor progress, due to ineffective uterine contraction is a major problem in modern obstetric care and one of the main reasons for the increased rate of caesarean deliveries, in particular among nulliparous women. Infusion with synthetic oxytocin is a commonly used treatment of hypotonic uterine contractions. Despite the widespread use of oxytocin no consensus exists regarding the dosage of oxytocin, both starting dose and increment of amount of oxytocin.
In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. The expected outcome is a decreased caesarean section rate and increased rate of spontaneous vaginal delivery for women with high dose of oxytocin for augmentation, without affecting neonatal outcomes or childbirth experiences negatively.
Primary outcome is caesarean delivery rate. Secondary outcomes are Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Based on a sample size calculation (α=0.05, β=0.80), 1045 women will be needed in each group. Analysis will be performed by the intention to treat.
Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.
- Conditions
- Birth; Delayed
- Being tested
- Oxytocin
- Keywords
- Delayed labour, dystocia, oxytocin augmentation, primiparous women, childbirth, childbirth experience, progress
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| High dose of oxytocin infusion | Experimental | Oxytocin: High dose infusion Receives: Drug: Oxytocin |
| Low dose of oxytocin infusion | Active comparator | Oxytocin: Low dose infusion Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean delivery rate
data from clinical records
Measured: At birth
Secondary outcomes (10)
Spontaneous vaginal birth rate
data from clinical records
Measured: At birth
Length of labour
data from clinical records
Measured: At birth
Hyper-stimulation of contractions
data from clinical records
Measured: At birth
Postpartum haemorrhage
data from clinical records
Measured: Two hours postpartum
Sphincter lacerations
data from clinical records
Measured: At birth
Epidural analgesia
data from clinical records
Measured: At birth
Experienced labour pain
VAS 0-100 mm where 100 is highest pain level
Measured: Two hours postpartum
Childbirth experience
Childbirth Experience Questionnaire (CEQ)
Measured: 1 month postpartum
Apgar score
data from clinical records
Measured: Five minutes postpartum
Neonatal intensive care
data from clinical records
Measured: 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startAug 2013
- Primary completion9 Jun 2016
- Study completion8 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Birth; DelayedStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587625
- Sponsor's protocol ID
- Oxytocin high low dose
- Acronym
- OxyHighLow
- Status last verified
- Mar 2019
- First submitted
- 19 Apr 2012
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data for primary and secondary outcome measures from the two groups will be submitted to the Swedish National Data Service (Svensk Nationell Datatjänst, SND), a national authority responsible for administrating sharing of research data.
Publications
Selin L, Berg M, Wennerholm UB, Dencker A. Dosage of oxytocin for augmentation of labor and women's childbirth experiences: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 May;100(5):971-978. doi: 10.1111/aogs.14042. Epub 2021 Jan 28.
PubMed 33176392Selin L, Wennerholm UB, Jonsson M, Dencker A, Wallin G, Wiberg-Itzel E, Almstrom E, Petzold M, Berg M. High-dose versus low-dose of oxytocin for labour augmentation: a randomised controlled trial. Women Birth. 2019 Aug;32(4):356-363. doi: 10.1016/j.wombi.2018.09.002. Epub 2018 Oct 16.
PubMed 30341003
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour
- ClinicalTrials.gov ID
- NCT01587625
- Acronym / sponsor ID
- OxyHighLow / Oxytocin high low dose
- Conditions
- Birth; Delayed
- Keywords
- Delayed labour, dystocia, oxytocin augmentation, primiparous women, childbirth, childbirth experience, progress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,376 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Aug 2013
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 8 Oct 2016 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.
Detailed description
The aim is to compare starting dose and increment of amount of oxytocin for augmentation of delayed labour to determine whether augmentation by high dose of oxytocin improves labour outcomes compared with a low dose of oxytocin, without effecting neonatal outcomes or birth experiences negatively.
Delay in labour, also described as poor progress, due to ineffective uterine contraction is a major problem in modern obstetric care and one of the main reasons for the increased rate of caesarean deliveries, in particular among nulliparous women. Infusion with synthetic oxytocin is a commonly used treatment of hypotonic uterine contractions. Despite the widespread use of oxytocin no consensus exists regarding the dosage of oxytocin, both starting dose and increment of amount of oxytocin.
In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. The expected outcome is a decreased caesarean section rate and increased rate of spontaneous vaginal delivery for women with high dose of oxytocin for augmentation, without affecting neonatal outcomes or childbirth experiences negatively.
Primary outcome is caesarean delivery rate. Secondary outcomes are Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Based on a sample size calculation (α=0.05, β=0.80), 1045 women will be needed in each group. Analysis will be performed by the intention to treat.
Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose of oxytocin infusion | Experimental | Drug: OxytocinOxytocin: High dose infusion |
| Low dose of oxytocin infusion | Active comparator | Drug: OxytocinOxytocin: Low dose infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy nulliparous women
- singleton pregnancy
- normal pregnancy
- cephalic presentation
- spontaneous onset of active labour
Key exclusion criteria (7 listed)
- Non-Swedish speaking women
- previous uterine surgery
- intrauterine growth retardation > - 22%
- malpresentation at time of inclusion
- intrapartal hemorrhage at time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin | Drug | High dose of oxytocin infusion, Low dose of oxytocin infusion |
Primary outcome
Caesarean delivery rate
Time frame: At birth
data from clinical records
10 secondary outcomes
Spontaneous vaginal birth rate
Time frame: At birth
Length of labour
Time frame: At birth
Hyper-stimulation of contractions
Time frame: At birth
Postpartum haemorrhage
Time frame: Two hours postpartum
Sphincter lacerations
Time frame: At birth
Epidural analgesia
Time frame: At birth
Experienced labour pain
Time frame: Two hours postpartum
Childbirth experience
Time frame: 1 month postpartum
Apgar score
Time frame: Five minutes postpartum
Neonatal intensive care
Time frame: 1 month postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 33176392Selin L, Berg M, Wennerholm UB, Dencker A. Dosage of oxytocin for augmentation of labor and women's childbirth experiences: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 May;100(5):971-978. doi: 10.1111/aogs.14042. Epub 2021 Jan 28.
- Derived from this study: PubMed 30341003Selin L, Wennerholm UB, Jonsson M, Dencker A, Wallin G, Wiberg-Itzel E, Almstrom E, Petzold M, Berg M. High-dose versus low-dose of oxytocin for labour augmentation: a randomised controlled trial. Women Birth. 2019 Aug;32(4):356-363. doi: 10.1016/j.wombi.2018.09.002. Epub 2018 Oct 16.
- Individual participant dataSharing planned: Yes. Data for primary and secondary outcome measures from the two groups will be submitted to the Swedish National Data Service (Svensk Nationell Datatjänst, SND), a national authority responsible for administrating sharing of research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Birth; Delayed, run by Göteborg University at 2 sites in Sweden.
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 7 inclusion and 7 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Caesarean delivery rate (time frame: At birth). 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 NCT01587625, which also lists 2 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 4 Mar 2019.