Postpartum HemorrhagePhase 4PPHNCT02277067
Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.
A Phase 4 study testing Carbetocin and Misoprostol in people with Postpartum Hemorrhage, run by Beni-Suef University at 1 site in Egypt.
Trial summary
We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Carbetocin and Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Aug 2021
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.
- Any medical disorder with pregnancy that carries a risk factor for PPH.
Who cannot join
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University
Cairo
Nesreen A Shehata, Lecturer
Abdelgany M Hassan, Lecturer
About this study
Official title: Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.
We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.
Read the detailed description
- Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011)
- Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012)
- Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009)
- Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute).
- Risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. Clinicians must be aware of risk factors for PPH and should take these into account for the wellbeing and safety of both the mother and the baby.RCOG GUIDLIN Table 1: Risk factors for PPH
- Suspected or proven placental abruption
- Known placenta praevia
- Multiple pregnancy
- Pre-eclampsia/gestational hypertension
- Previous PPH .
- Obesity (BMI >35)
- Anaemia (<9 g/dl)
- Delivery by elective caesarean section
- Induction of labour
- Retained placenta Tissue
- Prolonged labour (> 12 hours) .
- Big baby (> 4 kg) Royal College of Obstetrics and Gynecology.Green-top Guideline No. 52 May 2009 Minor revisions November 2009 and April 2011. Prevention and Management of Postpartum Hemorrhage. Thus our aim is to compare the effeciency and cost effectiveness of Carbitocin and Misoprostol in patients at high risk of PPH after C.S. in prevention of PPH.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin, Misoprostol
- Keywords
- PPH
- 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
Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
MisoprostolDrug
Also called Misotac
600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
| Study group | Role | What they receive |
|---|---|---|
| Pabal ( carbetocin) | Active comparator | Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head. Receives: Drug: Carbetocin |
| Misoprostol | Active comparator | Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone and size
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
Measured: One hour after the cesarean section
Secondary outcomes (1)
Blood loss
Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.
Measured: One hour after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277067
- Sponsor's protocol ID
- Beni-Suef 7
- Acronym
- PPH
- Status last verified
- Jan 2021
- First submitted
- 26 Oct 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.
- ClinicalTrials.gov ID
- NCT02277067
- Acronym / sponsor ID
- PPH / Beni-Suef 7
- Conditions
- Postpartum Hemorrhage
- Keywords
- PPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Oct 2014
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Oct 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.
We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.
Detailed description
- Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011)
- Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012)
- Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009)
- Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute).
- Risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. Clinicians must be aware of risk factors for PPH and should take these into account for the wellbeing and safety of both the mother and the baby.RCOG GUIDLIN Table 1: Risk factors for PPH
- Suspected or proven placental abruption
- Known placenta praevia
- Multiple pregnancy
- Pre-eclampsia/gestational hypertension
- Previous PPH .
- Obesity (BMI >35)
- Anaemia (<9 g/dl)
- Delivery by elective caesarean section
- Induction of labour
- Retained placenta Tissue
- Prolonged labour (> 12 hours) .
- Big baby (> 4 kg) Royal College of Obstetrics and Gynecology.Green-top Guideline No. 52 May 2009 Minor revisions November 2009 and April 2011. Prevention and Management of Postpartum Hemorrhage. Thus our aim is to compare the effeciency and cost effectiveness of Carbitocin and Misoprostol in patients at high risk of PPH after C.S. in prevention of PPH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pabal ( carbetocin) | Active comparator | Drug: CarbetocinPabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head. |
| Misoprostol | Active comparator | Drug: MisoprostolMisoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.
- Any medical disorder with pregnancy that carries a risk factor for PPH.
Key exclusion criteria (2 listed)
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation.
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: PabalPabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section. | Drug | Pabal ( carbetocin) |
| MisoprostolAlso: Misotac600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative. | Drug | Misoprostol |
Primary outcome
Uterine tone and size
Time frame: One hour after the cesarean section
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
1 secondary outcome
Blood loss
Time frame: One hour after cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- • Almog B,Malabarey O, Brown R, Abenhaim HA, Shrim A. (2011), Postpartum hemorrhage in low risk population. J Perinat Med. 2011 Sep; 39(5):495-8. Epub 2011 Jun 30. Department of Obstetrics and Gynecology, McGill University Health Center, Montreal, QC,Link provided by the sponsor.
- Advance misoprostol distribution for preventing and treating postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Feb 15; 2:CD009336. Maternal and Fetal Health Research Unit, Department of Obstetrics and Gynaecology, Obafemi Awolowo College of HealthLink provided by the sponsor.
- Maternal consequences of caesarean section. A retrospective study of intra-operative and postoperative maternal complications of caesarean section during a 10- year period. Eur J Obstet Gynecol Reprod Biol. 2009;74(1):1-6.Link provided by the sponsor.
- • Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, et al. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol 1999; 180:670-6.Link provided by the sponsor.
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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.
Nesreen A Shehata, MD principal investigator
Beni-Suef University
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 Beni-Suef 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 2 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 Feb 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201227866337, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine tone and size (time frame: One hour after the cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2021.