- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117647
Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage
Is Early Intervention Using Mansoura-VV Uterine Compression Sutures an Effective Procedure in the Management of Primary Atonic Postpartum Hemorrhage? : A Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- women diagnosed with atonic postpartum hemorrhage at the time of cesarean section after appropriate use of ecobolics
Exclusion Criteria:
- patients with placenta previa complete or incomplete centrails, and/or placenta accreta
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary postpartum haemorrhage from atony
Time Frame: first 24 hours post partum
|
blood loss more than 1000 cc.
|
first 24 hours post partum
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R/16.09.55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Partum Hemorrhage
-
Yariv yogevRabin Medical CenterUnknownPost-Partum Hemorrhage
-
Laboratoire français de Fractionnement et de BiotechnologiesCompleted
-
Hackensack Meridian HealthCompletedPost-partum Hemorrhage (PPH)United States
-
Tampere University HospitalCompletedBlood Transfusion | Post-partum HemorrhageFinland
-
University Hospital, MontpellierNot yet recruitingPost Partum Haemorrhage
-
Oxytone Bioscience BVTerminatedPost Partum HaemorrhageSweden
-
North Bristol NHS TrustFerring Pharmaceuticals; University of Bristol; University Hospitals Bristol... and other collaboratorsCompleted
-
Qazvin University Of Medical SciencesCompletedPost Partum HaemorrhageIran, Islamic Republic of
-
Hospices Civils de LyonUnknownPost Partum HaemorrhageFrance
-
University of PretoriaCompletedPrevention of Post Partum HaemorrhageSouth Africa
Clinical Trials on Mansoura-VV compression suture
-
Tianjin Eye HospitalRecruitingPrimary PterygiumChina
-
Mansoura University HospitalCompletedPlacenta AccretaEgypt
-
University of Roma La SapienzaCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalUnknownUterine Atony With Hemorrhage | Ovarian DysfunctionTurkey
-
Havva Betül BacakCompleted
-
Centre Hospitalier Universitaire de BesançonCompleted
-
Aswan University HospitalUnknownCesarean Section ComplicationsEgypt
-
Mansoura University HospitalCompleted
-
Alexandria UniversityCompleted