Post Partum HemorrhageNCT03117647
Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage
An observational study of Post Partum Hemorrhage, run by Mansoura University.
Trial summary
Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost established .The aim of this study was to assess the… Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Mansoura-VV compression suture
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 7 Dec 2016
- Phase
- Observational
- 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 19 to 42 years
- Women only
- Adult
Study population: women diagnosed with primary atonic PPH, during cesarean section when the uterus failed to contract after the routine doses of uterotonics.
Who may be able to join
- women diagnosed with atonic postpartum hemorrhage at the time of cesarean section after appropriate use of ecobolics
Who cannot join
- patients with placenta previa complete or incomplete centrails, and/or placenta accreta
About this study
Official title: Is Early Intervention Using Mansoura-VV Uterine Compression Sutures an Effective Procedure in the Management of Primary Atonic Postpartum Hemorrhage? : A Prospective Study
Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost established .The aim of this study was to assess the role of the Mansoura-VV uterine compression suture as an early intervention in the management of primary atonic postpartum hemorrhage.
Read the detailed description
This prospective observational study was carried out at the Obstetrics and Gynecology Department Mansoura University Hospital, and private settings in Mansoura, Egypt, during the period from May 2013 to December 2016. Inclusion criteria included women diagnosed with primary atonic PPH, during cesarean section when the uterus failed to contract after the routine doses of uterotonics. Women and their partners were counseled and signed a consent regarding the technique as an alternative to devascularization or hysterectomy. Exclusion criteria included patients with placenta previa complete or incomplete centrails, and/or placenta accreta. Also one case of atonic PPH, when the uterus was incompressible and failed to contract on bimanual compression was excluded from the study, as in our experience these cases failed to respond to any type of UCS.
In this series, immediately after anesthesia, all women received misoprostol 400 mcg (two tablets of MisotacR, Adwia Co, 6th October city, Egypt) sublingual, as well as 20 IU of oxytocin (Syntocinon, Sanofi Aventais, Egypt) in 50 0-mL lactated Ringer's solution as an intravenous infusion, after delivery of the baby and clamping of the umbilical cord. This is routine practice for all women undergoing CS in our department.
After closure of the uterine incision, uterine atony was diagnosed in 108 women when the uterus felt soft and flappy, and failed to respond to intermittent fundal massage, the second dose of the previously mentioned ecbolics was given. Then, bimanual compression of the uterus was attempted for 10 to 15 minutes until the tone of the uterus is regained as well as to assess the potential chances of success of the Mansoura-VV uterine compression suture.
Within 15 minutes of the diagnosis, the uterus was rechecked to identify any bleeding points. the investigators performed Mansoura-VV uterine compression suture. The right V was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened. (ii) The needle transfixed the right uterine wall from anterior to posterior, about 2 cm below the hysterotomy incision and 3 cm from the (this represents the apex of the V suture). (iii) after transfixation, the Vicryl was divided thus two threads from one transfixation each 50-cm threads penetrated the lower uterine segment; medial (M) and lateral (L) threads, each has anterior (aL and aM) and posterior (pL and pM) ends in relation to the uterus (iv) The free anterior and posterior ends of the lateral thread (aL and pL) were tied above the fundus with three double - throw knots about 3 cm from the right cornual border of the uterus forming the lateral limb of the V suture. (v) The free anterior and posterior ends of the medial threads (aM and pM) were tied above the fundus 2-3 cm medial to the lateral limb completing the V suture . The lead surgeon pulled the suture to provide moderate tension, while the assistant surgeon lift the uterus upward while perform a bimanual uterine compression to minimize trauma and to achieve or aid compression during the ligation of each vertical limb. (vi) using a similar technique, the left V suture was laid on the left side, and then the VV suture is completed.
The vagina was inspected to check for control of bleeding with Mansoura-VV sutures, the uterus cannot be stretched. Only one case (1/108) required additional bilateral uterine vessels ligation for control of bleeding, the abdomen was closed routinely. Antibiotics were given and continued postoperatively for 5 days.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Mansoura-VV compression suture
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mansoura-VV compression sutureProcedure or surgery
two compression suture both are v shaped apex of each suture placed 2 cm below suture line of C.S and 3 cm from the lateral border of the uterus on the right and left side
What is being measured
The primary outcome is the main question the study is designed to answer.
primary postpartum haemorrhage from atony
blood loss more than 1000 cc.
Measured: first 24 hours post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 May 2013
- Primary completion7 Dec 2016
- Study completion7 Dec 2016
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 Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WaleedAl Refaie, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117647
- Sponsor's protocol ID
- R/16.09.55
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Refaeey AEA, Abdelfattah H, Mosbah A, Gamal AM, Fayla E, Refaie W, Zaied A, Barakat RI, Seleem AK, Maher M. Is early intervention using Mansoura-VV uterine compression sutures an effective procedure in the management of primary atonic postpartum hemorrhage? : a prospective study. BMC Pregnancy Childbirth. 2017 May 31;17(1):160. doi: 10.1186/s12884-017-1349-x.
PubMed 28569213
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Early Intervention Using Mansoura-VV Uterine Compression Sutures an Effective Procedure in the Management of Primary Atonic Postpartum Hemorrhage? : A Prospective Study
- ClinicalTrials.gov ID
- NCT03117647
- Acronym / sponsor ID
- R/16.09.55
- Conditions
- Post Partum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 18 Apr 2017 (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.
Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost established .The aim of this study was to assess the role of the Mansoura-VV uterine compression suture as an early intervention in the management of primary atonic postpartum hemorrhage.
Detailed description
This prospective observational study was carried out at the Obstetrics and Gynecology Department Mansoura University Hospital, and private settings in Mansoura, Egypt, during the period from May 2013 to December 2016. Inclusion criteria included women diagnosed with primary atonic PPH, during cesarean section when the uterus failed to contract after the routine doses of uterotonics. Women and their partners were counseled and signed a consent regarding the technique as an alternative to devascularization or hysterectomy. Exclusion criteria included patients with placenta previa complete or incomplete centrails, and/or placenta accreta. Also one case of atonic PPH, when the uterus was incompressible and failed to contract on bimanual compression was excluded from the study, as in our experience these cases failed to respond to any type of UCS.
In this series, immediately after anesthesia, all women received misoprostol 400 mcg (two tablets of MisotacR, Adwia Co, 6th October city, Egypt) sublingual, as well as 20 IU of oxytocin (Syntocinon, Sanofi Aventais, Egypt) in 50 0-mL lactated Ringer's solution as an intravenous infusion, after delivery of the baby and clamping of the umbilical cord. This is routine practice for all women undergoing CS in our department.
After closure of the uterine incision, uterine atony was diagnosed in 108 women when the uterus felt soft and flappy, and failed to respond to intermittent fundal massage, the second dose of the previously mentioned ecbolics was given. Then, bimanual compression of the uterus was attempted for 10 to 15 minutes until the tone of the uterus is regained as well as to assess the potential chances of success of the Mansoura-VV uterine compression suture.
Within 15 minutes of the diagnosis, the uterus was rechecked to identify any bleeding points. the investigators performed Mansoura-VV uterine compression suture. The right V was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened. (ii) The needle transfixed the right uterine wall from anterior to posterior, about 2 cm below the hysterotomy incision and 3 cm from the (this represents the apex of the V suture). (iii) after transfixation, the Vicryl was divided thus two threads from one transfixation each 50-cm threads penetrated the lower uterine segment; medial (M) and lateral (L) threads, each has anterior (aL and aM) and posterior (pL and pM) ends in relation to the uterus (iv) The free anterior and posterior ends of the lateral thread (aL and pL) were tied above the fundus with three double - throw knots about 3 cm from the right cornual border of the uterus forming the lateral limb of the V suture. (v) The free anterior and posterior ends of the medial threads (aM and pM) were tied above the fundus 2-3 cm medial to the lateral limb completing the V suture . The lead surgeon pulled the suture to provide moderate tension, while the assistant surgeon lift the uterus upward while perform a bimanual uterine compression to minimize trauma and to achieve or aid compression during the ligation of each vertical limb. (vi) using a similar technique, the left V suture was laid on the left side, and then the VV suture is completed.
The vagina was inspected to check for control of bleeding with Mansoura-VV sutures, the uterus cannot be stretched. Only one case (1/108) required additional bilateral uterine vessels ligation for control of bleeding, the abdomen was closed routinely. Antibiotics were given and continued postoperatively for 5 days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women diagnosed with primary atonic PPH, during cesarean section when the uterus failed to contract after the routine doses of uterotonics.
Key inclusion criteria (1 listed)
- women diagnosed with atonic postpartum hemorrhage at the time of cesarean section after appropriate use of ecobolics
Key exclusion criteria (1 listed)
- patients with placenta previa complete or incomplete centrails, and/or placenta accreta
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 |
|---|---|---|
| Mansoura-VV compression suturetwo compression suture both are v shaped apex of each suture placed 2 cm below suture line of C.S and 3 cm from the lateral border of the uterus on the right and left side | Procedure or surgery | – |
Primary outcome
primary postpartum haemorrhage from atony
Time frame: first 24 hours post partum
blood loss more than 1000 cc.
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 20 Apr 2017.
- Derived from this study: PubMed 28569213El Refaeey AEA, Abdelfattah H, Mosbah A, Gamal AM, Fayla E, Refaie W, Zaied A, Barakat RI, Seleem AK, Maher M. Is early intervention using Mansoura-VV uterine compression sutures an effective procedure in the management of primary atonic postpartum hemorrhage? : a prospective study. BMC Pregnancy Childbirth. 2017 May 31;17(1):160. doi: 10.1186/s12884-017-1349-x.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Hemorrhage, run by Mansoura University.
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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
primary postpartum haemorrhage from atony (time frame: first 24 hours post partum). 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 NCT03117647, 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 20 Apr 2017.