Atonic Postpartum HemorrhageNCT05479357
Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage
A study testing Oxytocin and Carbetocin in people with Atonic Postpartum Hemorrhage and High Risk Pregnancy, run by Sohag University.
Trial summary
Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Atonic Postpartum Hemorrhage, High Risk Pregnancy
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2022to 30 Dec 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:
- History of postpartum hemorrhage.
- Delivery of a macrosomic baby (> 4000 g).
- Multiple gestation.
- Polyhydramnios.
- Grand Multiparity.
- Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
- Chorioamnionitis.
Who cannot join
- • Patients without high risk for post-partum hemorrhage.
- Patients at high risk for postpartum hemorrhage but will deliver vaginally.
- Patients with medical disorders complicating pregnancy.
- Patients with coagulation defects.
- Preterm pregnancies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial
Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.
Read the detailed description
Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.
The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.
- Conditions
- Atonic Postpartum Hemorrhage, High Risk Pregnancy
- Being tested
- Oxytocin, Carbetocin
- Keywords
- Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy
- 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
10 iu will be given intravenously.
CarbetocinDrug
100 micrograms will be given intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | the control group will be given 10 iu intravenously. Receives: Drug: Oxytocin |
| Carbetocin | Active comparator | the treatment group will be given 100 microgram intravenously. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Postpartum Hemorrhage
Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood.
Measured: First 24 hours after Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start28 Jul 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atonic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial (Simple randomization)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mahmoud Sabry, Sohag University
- Investigators
- Magdy M Ameen, MD, Principal investigator, Faculty of Medicine, Sohag UniversityAhmed T Ahmed, MD, Principal investigator, Faculty of Medicine, Sohag UniversityAmr O Abdelkareem, MD, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479357
- Sponsor's protocol ID
- Soh-Med-22-07-02
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waterstone M, Bewley S, Wolfe C. Incidence and predictors of severe obstetric morbidity: case-control study. BMJ. 2001 May 5;322(7294):1089-93; discussion 1093-4. doi: 10.1136/bmj.322.7294.1089.
PubMed 11337436Zhang WH, Alexander S, Bouvier-Colle MH, Macfarlane A; MOMS-B Group. Incidence of severe pre-eclampsia, postpartum haemorrhage and sepsis as a surrogate marker for severe maternal morbidity in a European population-based study: the MOMS-B survey. BJOG. 2005 Jan;112(1):89-96. doi: 10.1111/j.1471-0528.2004.00303.x.
PubMed 15663404Dahlke JD, Mendez-Figueroa H, Maggio L, Hauspurg AK, Sperling JD, Chauhan SP, Rouse DJ. Prevention and management of postpartum hemorrhage: a comparison of 4 national guidelines. Am J Obstet Gynecol. 2015 Jul;213(1):76.e1-76.e10. doi: 10.1016/j.ajog.2015.02.023. Epub 2015 Feb 28.
PubMed 25731692Mantel GD, Buchmann E, Rees H, Pattinson RC. Severe acute maternal morbidity: a pilot study of a definition for a near-miss. Br J Obstet Gynaecol. 1998 Sep;105(9):985-90. doi: 10.1111/j.1471-0528.1998.tb10262.x.
PubMed 9763050Brace V, Penney G, Hall M. Quantifying severe maternal morbidity: a Scottish population study. BJOG. 2004 May;111(5):481-4. doi: 10.1111/j.1471-0528.2004.00101.x.
PubMed 15104614Nyflot LT, Sandven I, Stray-Pedersen B, Pettersen S, Al-Zirqi I, Rosenberg M, Jacobsen AF, Vangen S. Risk factors for severe postpartum hemorrhage: a case-control study. BMC Pregnancy Childbirth. 2017 Jan 10;17(1):17. doi: 10.1186/s12884-016-1217-0.
PubMed 28068990Girault A, Deneux-Tharaux C, Sentilhes L, Maillard F, Goffinet F. Undiagnosed abnormal postpartum blood loss: Incidence and risk factors. PLoS One. 2018 Jan 10;13(1):e0190845. doi: 10.1371/journal.pone.0190845. eCollection 2018.
PubMed 29320553Nyflot LT, Stray-Pedersen B, Forsen L, Vangen S. Duration of labor and the risk of severe postpartum hemorrhage: A case-control study. PLoS One. 2017 Apr 6;12(4):e0175306. doi: 10.1371/journal.pone.0175306. eCollection 2017.
PubMed 28384337Maher MA, Sayyed TM, Elkhouly NI. Different routes and forms of uterotonics for treatment of retained placenta: a randomized clinical trial. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2179-2184. doi: 10.1080/14767058.2016.1242124. Epub 2016 Oct 19.
PubMed 27677547Lawrie TA, Rogozinska E, Sobiesuo P, Vogel JP, Ternent L, Oladapo OT. A systematic review of the cost-effectiveness of uterotonic agents for the prevention of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jul;146(1):56-64. doi: 10.1002/ijgo.12836. Epub 2019 May 20.
PubMed 31049950Withanathantrige M, Goonewardene M, Dandeniya R, Gunatilake P, Gamage S. Comparison of four methods of blood loss estimation after cesarean delivery. Int J Gynaecol Obstet. 2016 Oct;135(1):51-5. doi: 10.1016/j.ijgo.2016.03.036. Epub 2016 Jul 4.
PubMed 27451396Chong YS, Su LL, Arulkumaran S. Current strategies for the prevention of postpartum haemorrhage in the third stage of labour. Curr Opin Obstet Gynecol. 2004 Apr;16(2):143-50. doi: 10.1097/00001703-200404000-00008.
PubMed 15017343
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05479357
- Acronym / sponsor ID
- Soh-Med-22-07-02
- Conditions
- Atonic Postpartum Hemorrhage, High Risk Pregnancy
- Keywords
- Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Jul 2022 (actual)
- 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.
Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.
Detailed description
Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.
The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial (Simple randomization)
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocinthe control group will be given 10 iu intravenously. |
| Carbetocin | Active comparator | Drug: Carbetocinthe treatment group will be given 100 microgram intravenously. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:
Key exclusion criteria (5 listed)
- • Patients without high risk for post-partum hemorrhage.
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 will be given intravenously. | Drug | Oxytocin |
| Carbetocin100 micrograms will be given intravenously. | Drug | Carbetocin |
Primary outcome
Amount of Postpartum Hemorrhage
Time frame: First 24 hours after Delivery
Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 11337436Waterstone M, Bewley S, Wolfe C. Incidence and predictors of severe obstetric morbidity: case-control study. BMJ. 2001 May 5;322(7294):1089-93; discussion 1093-4. doi: 10.1136/bmj.322.7294.1089.
- Background: PubMed 15663404Zhang WH, Alexander S, Bouvier-Colle MH, Macfarlane A; MOMS-B Group. Incidence of severe pre-eclampsia, postpartum haemorrhage and sepsis as a surrogate marker for severe maternal morbidity in a European population-based study: the MOMS-B survey. BJOG. 2005 Jan;112(1):89-96. doi: 10.1111/j.1471-0528.2004.00303.x.
- Background: PubMed 25731692Dahlke JD, Mendez-Figueroa H, Maggio L, Hauspurg AK, Sperling JD, Chauhan SP, Rouse DJ. Prevention and management of postpartum hemorrhage: a comparison of 4 national guidelines. Am J Obstet Gynecol. 2015 Jul;213(1):76.e1-76.e10. doi: 10.1016/j.ajog.2015.02.023. Epub 2015 Feb 28.
- Background: PubMed 9763050Mantel GD, Buchmann E, Rees H, Pattinson RC. Severe acute maternal morbidity: a pilot study of a definition for a near-miss. Br J Obstet Gynaecol. 1998 Sep;105(9):985-90. doi: 10.1111/j.1471-0528.1998.tb10262.x.
- Background: PubMed 15104614Brace V, Penney G, Hall M. Quantifying severe maternal morbidity: a Scottish population study. BJOG. 2004 May;111(5):481-4. doi: 10.1111/j.1471-0528.2004.00101.x.
- Background: PubMed 28068990Nyflot LT, Sandven I, Stray-Pedersen B, Pettersen S, Al-Zirqi I, Rosenberg M, Jacobsen AF, Vangen S. Risk factors for severe postpartum hemorrhage: a case-control study. BMC Pregnancy Childbirth. 2017 Jan 10;17(1):17. doi: 10.1186/s12884-016-1217-0.
- Background: PubMed 29320553Girault A, Deneux-Tharaux C, Sentilhes L, Maillard F, Goffinet F. Undiagnosed abnormal postpartum blood loss: Incidence and risk factors. PLoS One. 2018 Jan 10;13(1):e0190845. doi: 10.1371/journal.pone.0190845. eCollection 2018.
- Background: PubMed 28384337Nyflot LT, Stray-Pedersen B, Forsen L, Vangen S. Duration of labor and the risk of severe postpartum hemorrhage: A case-control study. PLoS One. 2017 Apr 6;12(4):e0175306. doi: 10.1371/journal.pone.0175306. eCollection 2017.
- Background: PubMed 27677547Maher MA, Sayyed TM, Elkhouly NI. Different routes and forms of uterotonics for treatment of retained placenta: a randomized clinical trial. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2179-2184. doi: 10.1080/14767058.2016.1242124. Epub 2016 Oct 19.
- Background: PubMed 31049950Lawrie TA, Rogozinska E, Sobiesuo P, Vogel JP, Ternent L, Oladapo OT. A systematic review of the cost-effectiveness of uterotonic agents for the prevention of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jul;146(1):56-64. doi: 10.1002/ijgo.12836. Epub 2019 May 20.
- Background: PubMed 27451396Withanathantrige M, Goonewardene M, Dandeniya R, Gunatilake P, Gamage S. Comparison of four methods of blood loss estimation after cesarean delivery. Int J Gynaecol Obstet. 2016 Oct;135(1):51-5. doi: 10.1016/j.ijgo.2016.03.036. Epub 2016 Jul 4.
- Background: PubMed 15017343Chong YS, Su LL, Arulkumaran S. Current strategies for the prevention of postpartum haemorrhage in the third stage of labour. Curr Opin Obstet Gynecol. 2004 Apr;16(2):143-50. doi: 10.1097/00001703-200404000-00008.
- Individual participant dataSharing planned: No
Related trials for Atonic Postpartum Hemorrhage
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Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
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Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
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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.
Magdy M Ameen, MD principal investigator
Faculty of Medicine, Sohag University
Ahmed T Ahmed, MD principal investigator
Faculty of Medicine, Sohag University
Amr O Abdelkareem, MD principal investigator
Faculty of Medicine, Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Carbetocin in people with Atonic Postpartum Hemorrhage and High Risk Pregnancy, run by Sohag University.
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 8 inclusion and 5 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Eman M Sabry, MBBCh (+201012733125, emanmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Postpartum Hemorrhage (time frame: First 24 hours after Delivery). 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 NCT05479357, which also lists 12 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 2 Aug 2022.