Postpartum HemorrhageNCT03870503
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage
A study testing oxytocin, oxytocin plus misoprostol and Carbetocin in people with Postpartum Hemorrhage, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- oxytocin, oxytocin plus misoprostol and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Aug 2021
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Who cannot join
- gestational age<37 weeks,
- genital tract trauma,
- coagulation defect,
- women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- known hypersensitivity to carbetocin or oxytocin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.
Read the detailed description
The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.
Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.
- Conditions
- Postpartum Hemorrhage
- Being tested
- oxytocin, oxytocin plus misoprostol, Carbetocin
- Keywords
- Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin
- 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
Also called Active comparator
The patient will be received oxytocin 20 IU by intravenous infusion
oxytocin plus misoprostolDrug
Also called Active Comparator
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
CarbetocinDrug
Also called Active Comparator
The patient received Carbetocin 100 mic gm
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Active comparator | The patient will be received oxytocin 20 IU by intravenous infusion Receives: Drug: oxytocin |
| oxytocin plus misoprostol | Active comparator | The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol Receives: Drug: oxytocin; Drug: oxytocin plus misoprostol |
| Carbetocin | Active comparator | The patient will be received Carbetocin 100 mic gm IV Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of blood loss
calculation of the amount of blood loss by weighing the swabs and using pictorial charts
Measured: 6 hours post delivery
Secondary outcomes (2)
The number of patients develop blood loss more than 1000 ml
Calculation of the number of patients develop blood loss more than 1000 ml
Measured: 24 hours post delivery
The number of patient need blood transfusion
Calculation of number of patient need blood transfusion
Measured: 24 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2021
- Study completion1 Aug 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a prospective double-blind randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f allam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870503
- Sponsor's protocol ID
- aswu/201/19
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03870503
- Acronym / sponsor ID
- aswu/201/19
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 12 Mar 2019 (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.
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.
Detailed description
The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.
Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study will be a prospective double-blind randomized study
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Active comparator | Drug: oxytocinThe patient will be received oxytocin 20 IU by intravenous infusion |
| oxytocin plus misoprostol | Active comparator | Drug: oxytocin, Drug: oxytocin plus misoprostolThe patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol |
| Carbetocin | Active comparator | Drug: CarbetocinThe patient will be received Carbetocin 100 mic gm IV |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Key exclusion criteria (5 listed)
- gestational age<37 weeks,
- genital tract trauma,
- coagulation defect,
- women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- known hypersensitivity to carbetocin or oxytocin.
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 |
|---|---|---|
| oxytocinAlso: Active comparatorThe patient will be received oxytocin 20 IU by intravenous infusion | Drug | oxytocin, oxytocin plus misoprostol |
| oxytocin plus misoprostolAlso: Active ComparatorThe patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol | Drug | oxytocin plus misoprostol |
| CarbetocinAlso: Active ComparatorThe patient received Carbetocin 100 mic gm | Drug | Carbetocin |
Primary outcome
The amount of blood loss
Time frame: 6 hours post delivery
calculation of the amount of blood loss by weighing the swabs and using pictorial charts
2 secondary outcomes
The number of patients develop blood loss more than 1000 ml
Time frame: 24 hours post delivery
The number of patient need blood transfusion
Time frame: 24 hours post delivery
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 29 Sep 2021.
- 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.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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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
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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.
hany f allam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin, oxytocin plus misoprostol and Carbetocin in people with Postpartum Hemorrhage, run by Aswan University Hospital 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 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: finished, as of the sponsor's last update on 29 Sep 2021. 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?
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?
The amount of blood loss (time frame: 6 hours post 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 NCT03870503, 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 29 Sep 2021.