Postpartum HemorrhagePhase 4NCT03556852
CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE
A Phase 4 study testing Carbetocin and Misoprostol in people with Postpartum Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Carbetocin and Misoprostol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2018to 30 May 2019
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel > 10 gm/dl
- Noncomplicated pregnancy
Who cannot join
- Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
Read the detailed description
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin, Misoprostol
- 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
1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby
MisoprostolDrug
2 rectal misoprostol tablets (800 μg) after the delivery of the baby.
| Study group | Role | What they receive |
|---|---|---|
| CARBETOCIN | Active comparator | received 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby. Receives: Drug: Carbetocin |
| MISOPROSTOL | Active comparator | received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of post partum hemorrhage after vaginal delivery
Number of participants experienced postpartum hemorrhage
Measured: 24 hours after delivery
Secondary outcomes (1)
drugs side effects
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching
Measured: 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 posted14 Jun 2018
- Study start2 Jul 2018
- Primary completion24 May 2019
- Study completion30 May 2019
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 Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556852
- Sponsor's protocol ID
- 38
- Status last verified
- Oct 2019
- First submitted
- 4 Jun 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maged AM, Waly M, Fahmy RM, Dieb AS, Essam A, Salah NM, Hussein EA, Nabil H. Carbetocin versus rectal misoprostol for management of third stage of labor among women with low risk of postpartum hemorrhage. Int J Gynaecol Obstet. 2020 Feb;148(2):238-242. doi: 10.1002/ijgo.13056. Epub 2019 Dec 2.
PubMed 31736069
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE
- ClinicalTrials.gov ID
- NCT03556852
- Acronym / sponsor ID
- 38
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 14 Jun 2018 (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.
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
Detailed description
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARBETOCIN | Active comparator | Drug: Carbetocinreceived 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby. |
| MISOPROSTOL | Active comparator | Drug: Misoprostolreceived 4 rectal misoprostol tablets (800 μg) after the delivery of the baby. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel > 10 gm/dl
- Noncomplicated pregnancy
Key exclusion criteria (1 listed)
- Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum 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 |
|---|---|---|
| Carbetocin1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby | Drug | CARBETOCIN |
| Misoprostol2 rectal misoprostol tablets (800 μg) after the delivery of the baby. | Drug | MISOPROSTOL |
Primary outcome
prevention of post partum hemorrhage after vaginal delivery
Time frame: 24 hours after delivery
Number of participants experienced postpartum hemorrhage
1 secondary outcome
drugs side effects
Time frame: 24 hours after 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 11 Oct 2019.
- Derived from this study: PubMed 31736069Maged AM, Waly M, Fahmy RM, Dieb AS, Essam A, Salah NM, Hussein EA, Nabil H. Carbetocin versus rectal misoprostol for management of third stage of labor among women with low risk of postpartum hemorrhage. Int J Gynaecol Obstet. 2020 Feb;148(2):238-242. doi: 10.1002/ijgo.13056. Epub 2019 Dec 2.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
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
RecruitingPhase 2
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.
Ahmed Maged principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbetocin and Misoprostol in people with Postpartum Hemorrhage, run by Cairo 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 2 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 11 Oct 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
prevention of post partum hemorrhage after vaginal delivery (time frame: 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 NCT03556852, 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 11 Oct 2019.