Postpartum HemorrhageNCT01608958
IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 3 sites in 3 countries.
Trial summary
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- 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
- 653 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2012to Dec 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All women who present in active labor for a live birth at the study hospital will be considered for participation in the study
Who cannot join
- Planned or transferred for delivery via Cesarean section
- Not delivering a live birth
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
- Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Turkey (Türkiye)1 site
SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
Ankara
About this study
Official title: Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
Read the detailed description
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin
- Keywords
- Postpartum hemorrhage, Oxytocin, Third stage of labor, Hemoglobin, Prevention, Intravenous, Intramuscular
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IV infusion | Active comparator | Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby. Receives: Drug: Oxytocin |
| IM Injection | Active comparator | Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood loss (ml)
Measured: minimum of 1 hour after delivery of baby
Secondary outcomes (6)
Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml
Measured: minimum of 1 hour after delivery of baby
Change in hemoglobin from pre-delivery to postpartum
Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.
Measured: 12-24 hours after delivery
Time to placental delivery
Measured: minimum of 1 hour after delivery of baby
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy
Measured: minimum of 1 hour after delivery of baby
Side effects 1 hour postpartum
Measured: 1 hour postpartum
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward
Measured: arrival to labor ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionDec 2012
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 Postpartum HemorrhageStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research and Consultancy in Reproductive Health, Hung Vuong Hospital, MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MHS, Principal investigator, Gynuity Health ProjectsJill Durocher, Principal investigator, Gynuity Health ProjectsJennifer Blum, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608958
- Sponsor's protocol ID
- 3000
- Status last verified
- Mar 2016
- First submitted
- 29 May 2012
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT01608958
- Acronym / sponsor ID
- 3000
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Oxytocin, Third stage of labor, Hemoglobin, Prevention, Intravenous, Intramuscular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Center for Research and Consultancy in Reproductive Health, Hung Vuong Hospital, MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 May 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.
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
Detailed description
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV infusion | Active comparator | Drug: OxytocinOxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby. |
| IM Injection | Active comparator | Drug: OxytocinOxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women who present in active labor for a live birth at the study hospital will be considered for participation in the study
Key exclusion criteria (4 listed)
- Planned or transferred for delivery via Cesarean section
- Not delivering a live birth
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
- Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
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 |
|---|---|---|
| Oxytocin10 IU oxytocin in 500 ml infusion | Drug | IV infusion |
| Oxytocin10 IU oxytocin IM injection | Drug | IM Injection |
Primary outcome
Mean blood loss (ml)
Time frame: minimum of 1 hour after delivery of baby
6 secondary outcomes
Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml
Time frame: minimum of 1 hour after delivery of baby
Change in hemoglobin from pre-delivery to postpartum
Time frame: 12-24 hours after delivery
Time to placental delivery
Time frame: minimum of 1 hour after delivery of baby
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy
Time frame: minimum of 1 hour after delivery of baby
Side effects 1 hour postpartum
Time frame: 1 hour postpartum
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward
Time frame: arrival to labor ward
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 28 Mar 2016.
- 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.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Ilana Dzuba, MHS principal investigator
Gynuity Health Projects
Jill Durocher principal investigator
Gynuity Health Projects
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 3 sites in 3 countries.
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 1 inclusion and 4 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ecuador, Turkey (Türkiye), Vietnam. 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?
Mean blood loss (ml) (time frame: minimum of 1 hour after delivery of baby). 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 NCT01608958, 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 28 Mar 2016.