DeliveryPhase 3PPHNCT02304042
Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial
A Phase 3 study testing Carbetocin and Oxytocin in people with Delivery, run by Cairo University at 2 sites in Egypt.
Trial summary
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Delivery
- What is being tested?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2014to Jul 2015
- Phase
- Phase 3
- 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
- Women with at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, ultrasound estimated fetal weight>4kg and induction of labour.
Who cannot join
- Gestational age <37 weeks
- Placenta previa
- Hypertension.
- Preeclampsia.
- Cardiac, renal or liver diseases
- Known hypersensitivity to Carbetocin.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
BeniSuef University hospitals
BeniSuef
Cairo University Hospitals
Cairo
About this study
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. The investigators will not include a control group for ethical reasons.
Read the detailed description
Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries (1). Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.
Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.
Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.
Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by CS under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin.
The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients with at least 2 risk factors for developing atonic PPH will be approached in the antenatal clinic or early in labour if appropriate. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, fetal macrosomia>4kg and induction of labour. Women will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. We will not include a control group for ethical reasons.
The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Carbetocin will be given slowly iv after delivery of the anterior shoulder.
OxytocinDrug
Oxytocin will be given slowly iv after delivery of the anterior shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Active comparator | 125 women will receive carbetocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder Receives: Drug: Carbetocin |
| Oxytocin | Active comparator | 125 women will receive carbetocin oxytocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for other uterotonics
After giving the drug, the uterine tone will be felt and amount of bleeding will be estimated.
Measured: 2 minutes after giving the drug
Secondary outcomes (1)
Bleeding>500ml
The amount of bleeding will be estimated 2 minutes after giving the drug.
Measured: 2 minutes after giving the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliveryStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelGany Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304042
- Sponsor's protocol ID
- PPH 2
- Acronym
- PPH
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2014
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x.
PubMed 17567419Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14.
PubMed 21668768
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02304042
- Acronym / sponsor ID
- PPH / PPH 2
- Conditions
- Delivery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Dec 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.
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. The investigators will not include a control group for ethical reasons.
Detailed description
Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries (1). Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.
Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.
Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.
Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by CS under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin.
The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients with at least 2 risk factors for developing atonic PPH will be approached in the antenatal clinic or early in labour if appropriate. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, fetal macrosomia>4kg and induction of labour. Women will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. We will not include a control group for ethical reasons.
The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Active comparator | Drug: Carbetocin125 women will receive carbetocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder |
| Oxytocin | Active comparator | Drug: Oxytocin125 women will receive carbetocin oxytocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, ultrasound estimated fetal weight>4kg and induction of labour.
Key exclusion criteria (6 listed)
- Gestational age <37 weeks
- Placenta previa
- Hypertension.
- Preeclampsia.
- Cardiac, renal or liver 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 |
|---|---|---|
| CarbetocinCarbetocin will be given slowly iv after delivery of the anterior shoulder. | Drug | Carbetocin |
| OxytocinOxytocin will be given slowly iv after delivery of the anterior shoulder. | Drug | Oxytocin |
Primary outcome
Need for other uterotonics
Time frame: 2 minutes after giving the drug
After giving the drug, the uterine tone will be felt and amount of bleeding will be estimated.
1 secondary outcome
Bleeding>500ml
Time frame: 2 minutes after giving the drug.
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 2 Jul 2015.
- Background: PubMed 17567419Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x.
- Background: PubMed 21668768Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carbetocin and Oxytocin in people with Delivery, run by Cairo University at 2 sites 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: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Need for other uterotonics (time frame: 2 minutes after giving the drug). 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 NCT02304042, which also lists 2 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 Jul 2015.