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The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta

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ClinicalTrials.gov Identifier: NCT02590484
Recruitment Status : Unknown
Verified October 2015 by Ahmed Rabie Abdelraheim, Minia University.
Recruitment status was:  Recruiting
First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed Rabie Abdelraheim, Minia University

Brief Summary:
Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The aim of this study is to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.

Condition or disease Intervention/treatment Phase
Placenta Previa Placenta Previa Accreta Procedure: The cervix as a natural tamponade (cervical inversion) Not Applicable

Detailed Description:

Background: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with placenta accreta may reach as high as 7-10%. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze, balloon tamponades, the B-Lynch suture, insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries, but there is a wide variation in the success rate of these maneuvers. In a case report, Dawlatly et al. (2007) described a simple technique of suturing an inverted lip of the cervix over the bleeding placental bed that was successful in controlling the bleeding, saving the patient's life, and preserving her uterus.

The objective of this trial is to evaluate the safety and efficacy of the use of this Dawlatly stitch as a natural tamponade for controlling postpartum haemorrhage in cases of placenta previa and/ or placenta previa accreta.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study
Study Start Date : June 2012
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: The cervix as a natural tamponade (cervical inversion)
    Suturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding.
    Other Name: Dawlatly stitch, cervical inversion


Primary Outcome Measures :
  1. Successful control of postpartum haemorrhage (PPH) [ Time Frame: Intra-operative and up to 24 hours postpartum ]
    Control of PPH and vaginal bleeding after employing the technique

  2. Number of cases undergoing hysterectomy to control PPH [ Time Frame: Intra-operative and up to 24 hours postpartum ]
    Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding

  3. Incidence of complications [ Time Frame: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  1. All participating women had one or more previous cesarean deliveries.
  2. were diagnosed with placenta previa and/ or placenta previa accreta by ultrasound. When the ultrasound result was not conclusive for placenta accreta, MRI was performed.
  3. All participating women desired to preserve their fertility
  4. Patients with focal (partial) placenta previa accreta/ placenta previa.

Exclusion Criteria:

  1. placenta percreta.
  2. diffuse placenta accreta or increta.
  3. uncontrollable postpartum hemorrhage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590484


Contacts
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Contact: Ahmed R Abdelraheim, MD, MRCOG +201096860338 arabdelraheim@yahoo.com

Locations
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Egypt
Department of Obstetrics and Gynaecology, Minia University Hospital Recruiting
Minia, Egypt
Contact: Ahmed Abdelraheim, MD, MRCOG    +201096860338    arabdelraheim@yahoo.com   
Sponsors and Collaborators
Minia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Rabie Abdelraheim, Dr Ahmed Rabie Abdelraheim, lecturer of Obstetrics And Gynaecology, Minia University
ClinicalTrials.gov Identifier: NCT02590484    
Other Study ID Numbers: MUH14367
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Placenta Previa
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases