Postpartum HemorrhageNCT01600612
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
A study testing carbetocin, misopristol and oxytocin in people with Postpartum Hemorrhage, run by Sohag University at 1 site in Egypt.
Trial summary
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- carbetocin, misopristol and 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 siteEgypt
- Study dates
- Sep 2012to Jul 2013
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary atonic postpartum hemorrhage after vaginal delivery
Who cannot join
- Patients who delivered by caesarean section
- Retained placenta
- Traumatic postpartum hemorrhage
- Associated coagulopathy
- Chronic medical illness (hepatic , renal diseases)
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag, Sohag Governorate, 1224
Mostafa M Abdel Khalek, MD, 01226534893, elgalawy@yahoo.com
Salah M Rasheed, MD
About this study
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.
Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.
Read the detailed description
The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.
Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.
- Conditions
- Postpartum Hemorrhage
- Being tested
- carbetocin, misopristol, oxytocin
- Keywords
- postpartum hemorrhage, oxytocin, carbetocin, misopristol
- 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 pabal
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
misopristolDrug
Also called Misotac
600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
oxytocinDrug
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | 30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage Receives: Drug: oxytocin |
| carbetocin | Active comparator | 10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage Receives: Drug: carbetocin |
| misopristol | Active comparator | 600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage Receives: Drug: misopristol |
What is being measured
The primary outcome is the main question the study is designed to answer.
control of postpartum hemorrhage
Measured: within 20 minutes of administration
Secondary outcomes (1)
time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.
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 posted17 May 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
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.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Salah M Rasheed, Sohag University
- Investigators
- Salah M Rasheed, MD, Study director, Department of Obstetrics and Gynecology, Sohag university, Egyptmagdy M Amin, MD, Study chair, Department of obstetrics and Gynecology, Sohag university, EgyptAhmed H Abd-Ella, MD, Principal investigator, Department of obstetrics and Gynecology, Qena university, EgyptAhmed M Abo Elhassan, MD, Principal investigator, Department of obstetrics and Gynecology, Assuit university, EgyptMazen A El Zahry, M.D., Principal investigator, Department of Obstetrics and Gynecology, Al Azhar university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600612
- Sponsor's protocol ID
- salah-1
- Status last verified
- May 2013
- First submitted
- 16 May 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
PubMed 33232518
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT01600612
- Acronym / sponsor ID
- salah-1
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, oxytocin, carbetocin, misopristol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 17 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.
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.
Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.
Detailed description
The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.
Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: oxytocin30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage |
| carbetocin | Active comparator | Drug: carbetocin10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage |
| misopristol | Active comparator | Drug: misopristol600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary atonic postpartum hemorrhage after vaginal delivery
Key exclusion criteria (6 listed)
- Patients who delivered by caesarean section
- Retained placenta
- Traumatic postpartum hemorrhage
- Associated coagulopathy
- Chronic medical illness (hepatic , renal diseases)
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: pabal10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage | Drug | carbetocin |
| misopristolAlso: Misotac600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage | Drug | misopristol |
| oxytocin30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage | Drug | Oxytocin |
Primary outcome
control of postpartum hemorrhage
Time frame: within 20 minutes of administration
1 secondary outcome
time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Derived from this study: PubMed 33232518Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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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.
Salah M Rasheed, MD study director
Department of Obstetrics and Gynecology, Sohag university, Egypt
magdy M Amin, MD study chair
Department of obstetrics and Gynecology, Sohag university, Egypt
Ahmed H Abd-Ella, MD principal investigator
Department of obstetrics and Gynecology, Qena university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbetocin, misopristol and oxytocin in people with Postpartum Hemorrhage, run by Sohag University at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 31 May 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salah M Rasheed, MD (01224653702, salahrasheed67@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control of postpartum hemorrhage (time frame: within 20 minutes of administration). 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 NCT01600612, 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 31 May 2013.