Postpartum HemorrhageNCT02660567
Amr's Maneuver and Postpartum Hemorrhage
A study testing Amr maneuver in people with Postpartum Hemorrhage, run by ClinAmygate at 1 site in Egypt.
Trial summary
The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Amr maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to 20 Jul 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included
Who cannot join
- Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone
Read the detailed description
Primary:
Compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone
Secondary:
Comparing:
- The amount of blood loss in each arm of the study
- Hematocrit before and after labor
- Duration from delivery of placenta till discharge from the delivery room
- Conditions
- Postpartum Hemorrhage
- Being tested
- Amr maneuver
- Keywords
- postpartum hemorrhage, PPH, atonic, new maneuver
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amr maneuverProcedure or surgery
sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds
| Study group | Role | What they receive |
|---|---|---|
| Amr Maneuver | Experimental | Active management of third stage plus Amr's maneuver Receives: Procedure: Amr maneuver |
| Active management alone | No intervention | Active management of third stage alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postpartum hemorrhage
the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Ain Shams University, October 6 University, National Research Centre, Egypt
- Responsible party
- Sponsor
- Investigators
- Osama Azmy, MD, Principal investigator, Egypt National Research Centre Reproductive Health Research DepartmentEmad RH Issak, DM, Study director, ClinAmygate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660567
- Sponsor's protocol ID
- 15127
- Status last verified
- May 2019
- First submitted
- 19 Jan 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
PubMed 32609374Hamdy A, Azmy O, Lotfy R, Attia AA, Elsherbini MM, Al Sawaf A, Soliman MM, Sharaf MF, Kamel A, Abd El-Raouf MN, Salem S, Rasheed MA, Torky H, Issak ER. Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jan;144(1):56-61. doi: 10.1002/ijgo.12687. Epub 2018 Oct 22.
PubMed 30281778
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02660567
- Acronym / sponsor ID
- 15127
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, PPH, atonic, new maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- Cairo University, Ain Shams University, October 6 University, National Research Centre, Egypt
- Study start
- Mar 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 21 Jan 2016 (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.
The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone
Detailed description
Primary:
Compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone
Secondary:
Comparing:
- The amount of blood loss in each arm of the study
- Hematocrit before and after labor
- Duration from delivery of placenta till discharge from the delivery room
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amr Maneuver | Experimental | Procedure: Amr maneuverActive management of third stage plus Amr's maneuver |
| Active management alone | No intervention | –Active management of third stage alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included
Key exclusion criteria (1 listed)
- Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery
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 |
|---|---|---|
| Amr maneuversustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds | Procedure or surgery | Amr Maneuver |
Primary outcome
the incidence of postpartum hemorrhage
Time frame: 24 hour
the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage
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 10 May 2019.
- Derived from this study: PubMed 32609374Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
- Derived from this study: PubMed 30281778Hamdy A, Azmy O, Lotfy R, Attia AA, Elsherbini MM, Al Sawaf A, Soliman MM, Sharaf MF, Kamel A, Abd El-Raouf MN, Salem S, Rasheed MA, Torky H, Issak ER. Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jan;144(1):56-61. doi: 10.1002/ijgo.12687. Epub 2018 Oct 22.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
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.
Osama Azmy, MD principal investigator
Egypt National Research Centre Reproductive Health Research Department
Emad RH Issak, DM study director
ClinAmygate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amr maneuver in people with Postpartum Hemorrhage, run by ClinAmygate 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 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 10 May 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.
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 incidence of postpartum hemorrhage (time frame: 24 hour). 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 NCT02660567, 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 10 May 2019.