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Post Partum HemorrhageNCT03117647

Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage

An observational study of Post Partum Hemorrhage, run by Mansoura University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. 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.

  1. First posted18 Apr 2017
  2. Study start1 May 2013
  3. Primary completion7 Dec 2016
  4. Study completion7 Dec 2016

Resources

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)
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

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.

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