Third Stage of LabourPhase 4NCT00200252
Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
A Phase 4 study testing oxytocin in people with Third Stage of Labour, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Third Stage of Labour
- 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
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 19 years and older
- singleton pregnancy
- 32 weeks gestation
- spontaneous vaginal delivery
Who cannot join
- previous postpartum hemorrhage
- placenta previa
- grand multiparity (>4)
- anticoagulation therapy
- delivery prior to 32 weeks gestation
- operative vaginal delivery
Show all 10Show fewer
- antepartum hemorrhage > 20 weeks
- hemoglobin <10g/dL
- multiple gestation
- intrauterine death
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour
Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.
- Conditions
- Third Stage of Labour
- Being tested
- oxytocin
- Keywords
- oxytocin, third stage, dose, route, blood loss
- Medical subject headings
- Hemorrhage
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 |
|---|---|---|
| group B | Active comparator | women in group B will receive 10 uts oxytocin IM Receives: Drug: oxytocin |
| group C | Active comparator | women in group C will receive oxytocin 5 uts IV Receives: Drug: oxytocin |
| group A | Active comparator | women in group A will receive oxytocin 5 uts IM Receives: Drug: oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hematocrit
Secondary outcomes (13)
estimated blood loss
postpartum hemorrhage (estimated blood loss > 500cc)
severe postpartum hemorrhage (estimated blood loss > 1000cc)
incidence of hypotension
length of third stage of labour
need for blood transfusion
incidence of retained placenta
need for dilatation and curettage
need for hysterectomy
need for additional oxytocics after delivery
postpartum antibiotic use
maternal satisfaction
bleeding needing readmission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Stage of LabourStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Investigators
- Colleen L Cook, MD, Principal investigator, Resident, Discipline Obstetrics and Gynecology, Memorial University of NewfoundlandJoan Crane, MD, Study director, Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200252
- Sponsor's protocol ID
- HIC05.79
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2005
- Last updated
- 9 Nov 2012
- Results posted
- No
Publications
Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
PubMed 33169839
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour
- ClinicalTrials.gov ID
- NCT00200252
- Acronym / sponsor ID
- HIC05.79
- Conditions
- Third Stage of Labour
- Keywords
- oxytocin, third stage, dose, route, blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Sep 2005 (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.
Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group B | Active comparator | Drug: oxytocinwomen in group B will receive 10 uts oxytocin IM |
| group C | Active comparator | Drug: oxytocinwomen in group C will receive oxytocin 5 uts IV |
| group A | Active comparator | Drug: oxytocinwomen in group A will receive oxytocin 5 uts IM |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 19 years and older
- singleton pregnancy
- 32 weeks gestation
- spontaneous vaginal delivery
Key exclusion criteria (10 listed)
- previous postpartum hemorrhage
- placenta previa
- grand multiparity (>4)
- anticoagulation therapy
- delivery prior to 32 weeks gestation
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 | group A, group B, group C |
Primary outcome
change in hematocrit
13 secondary outcomes
estimated blood loss
postpartum hemorrhage (estimated blood loss > 500cc)
severe postpartum hemorrhage (estimated blood loss > 1000cc)
incidence of hypotension
length of third stage of labour
need for blood transfusion
incidence of retained placenta
need for dilatation and curettage
need for hysterectomy
need for additional oxytocics after delivery
postpartum antibiotic use
maternal satisfaction
bleeding needing readmission
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 9 Nov 2012.
- Derived from this study: PubMed 33169839Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
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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.
Colleen L Cook, MD principal investigator
Resident, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
Joan Crane, MD study director
Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxytocin in people with Third Stage of Labour, run by Memorial University of Newfoundland at 1 site in Canada.
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 4 inclusion and 10 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in hematocrit. 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 NCT00200252, which also lists 1 linked publication.
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 9 Nov 2012.