Postpartum HemorrhagePhase 2NCT02079558
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
A Phase 2 study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. 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?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to Sep 2013
- Phase
- Phase 2
- 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
- At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin
Who cannot join
- Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
Trial locations and contacts
1 site in 1 country.
Iran1 site
Infertility and Reproductive Health Research Center
Tehran, Tehran Province, 1985717443
About this study
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin, Oxytocin
- Keywords
- prevention, cesarean section
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin,, Pabal,, Lonactene
Carbetocin with single 100 microg IV dosage was used in this investigation
OxytocinDrug
Also called Pitocin
Oxytocin with 30 international units (IU) IV infusion was used in this investigation
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | A single 100 microgram IV dose of carbetocin after operation Receives: Drug: Oxytocin |
| Carbetocin | Experimental | A standard 30 international units (IU) IV infusion of oxytocin during two hours Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening of Cessation of bleeding
Measured: screening until 24 hours after placenta disconnection
time duration to stop bleeding in the case of post-cesarean section
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Robabeh Taheripanah, Shahid Beheshti University of Medical Sciences
- Investigators
- Robabeh Taheripanah, MD-Gyn., Principal investigator, Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079558
- Sponsor's protocol ID
- IRHRC-021
- Other IDs
- JANU2014TAHERIPANAH
- Status last verified
- Mar 2014
- First submitted
- 13 Jan 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.
PubMed 28707488
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
- ClinicalTrials.gov ID
- NCT02079558
- Acronym / sponsor ID
- IRHRC-021
- Conditions
- Postpartum Hemorrhage
- Keywords
- prevention, cesarean section
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Mar 2014 (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.
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinA single 100 microgram IV dose of carbetocin after operation |
| Carbetocin | Experimental | Drug: CarbetocinA standard 30 international units (IU) IV infusion of oxytocin during two hours |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin
Key exclusion criteria (1 listed)
- Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
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 |
|---|---|---|
| CarbetocinAlso: Duratocin,, Pabal,, LonacteneCarbetocin with single 100 microg IV dosage was used in this investigation | Drug | Carbetocin |
| OxytocinAlso: PitocinOxytocin with 30 international units (IU) IV infusion was used in this investigation | Drug | Oxytocin |
Primary outcome
screening of Cessation of bleeding
Time frame: screening until 24 hours after placenta disconnection
time duration to stop bleeding in the case of post-cesarean section
Time frame: 24 hours
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 6 Mar 2014.
- Derived from this study: PubMed 28707488Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.
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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.
Robabeh Taheripanah, MD-Gyn. principal investigator
Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 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 6 Mar 2014. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
screening of Cessation of bleeding (time frame: screening until 24 hours after placenta disconnection). 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 NCT02079558, 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 6 Mar 2014.