Postpartum HemorrhageNCT01914419
Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Egypt.
Trial summary
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, 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
- 4,983 participants
- Where
- 2 sitesEgypt
- Study dates
- Apr 2014to Sep 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- 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
- Administration of a pre-delivery uterotonic to induce or augment labor
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Shatby Maternity Hospital, Alexandria University
Alexandria
El Galaa Teaching Hospital
Cairo
About this study
Official title: Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion 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 intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
Read the detailed description
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin
- Keywords
- Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus
- Medical subject headings
- Postpartum 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 |
|---|---|---|
| IV infusion | Active comparator | Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby. Receives: Drug: Oxytocin |
| IV bolus | Active comparator | Oxytocin 10 IU will be administered by IV bolus 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 by IM injection 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.
Proportion of women with postpartum blood loss equal to or greater than 500 mL
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Measured: 1 hour after delivery of baby
Secondary outcomes (7)
Mean postpartum blood loss
Mean blood loss as measured in a plastic, calibrated container.
Measured: 1 hour after delivery of the baby
Proportion of women with postpartum blood loss equal to or greater than 350 mL
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Measured: 1 hour after delivery of the baby
Proportion of women with postpartum blood loss equal to or greater than 1000 mL
Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.
Measured: 1 hour after delivery
Mean change in hemoglobin pre-delivery to postpartum
Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.
Measured: At least 12 hours after removal of IV and within 48 hours of delivery of the baby
Time to delivery of placenta
Time interval in minutes between delivery of the baby and delivery of the placenta
Measured: Within 1 hour of delivery of the baby
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy
Measured: Within 1 hour of delivery of the baby
Side effects 1 hour postpartum
Measured: 1 hour after delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- El Galaa Teaching Hospital, University of Alexandria
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsRasha Dabash, MPH, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MHS, Principal investigator, Gynuity Health ProjectsJill Durocher, Principal investigator, Gynuity Health ProjectsDyanna Charles, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914419
- Sponsor's protocol ID
- 3000a
- Status last verified
- Feb 2016
- First submitted
- 31 Jul 2013
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- 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 33169839Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2.
PubMed 30658605
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT01914419
- Acronym / sponsor ID
- 3000a
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,983 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- El Galaa Teaching Hospital, University of Alexandria
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Aug 2013 (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 intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
Detailed description
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV infusion | Active comparator | Drug: OxytocinOxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby. |
| IV bolus | Active comparator | Drug: OxytocinOxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby. |
| IM injection | Active comparator | Drug: OxytocinOxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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 (3 listed)
- Planned or transferred for delivery via Cesarean section
- Administration of a pre-delivery uterotonic to induce or augment labor
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
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 | IM injection, IV bolus, IV infusion |
Primary outcome
Proportion of women with postpartum blood loss equal to or greater than 500 mL
Time frame: 1 hour after delivery of baby
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
7 secondary outcomes
Mean postpartum blood loss
Time frame: 1 hour after delivery of the baby
Proportion of women with postpartum blood loss equal to or greater than 350 mL
Time frame: 1 hour after delivery of the baby
Proportion of women with postpartum blood loss equal to or greater than 1000 mL
Time frame: 1 hour after delivery
Mean change in hemoglobin pre-delivery to postpartum
Time frame: At least 12 hours after removal of IV and within 48 hours of delivery of the baby
Time to delivery of placenta
Time frame: Within 1 hour of delivery of the baby
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy
Time frame: Within 1 hour of delivery of the baby
Side effects 1 hour postpartum
Time frame: 1 hour after delivery of the baby
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 11 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.
- Derived from this study: PubMed 30658605Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Rasha Dabash, MPH principal investigator
Gynuity Health Projects
Ilana Dzuba, MHS principal investigator
Gynuity Health Projects
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 Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Egypt.
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 3 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 11 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 2 sites in Egypt. 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?
Proportion of women with postpartum blood loss equal to or greater than 500 mL (time frame: 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 NCT01914419, 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 11 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.