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Trial record 32 of 618 for:    Hemorrhage AND postpartum

the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis (PPH)

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ClinicalTrials.gov Identifier: NCT02157441
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

Brief Summary:
Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles

Condition or disease Intervention/treatment Phase
Placenta Previa Complete Centralis Procedure: lower uterine compression sutures Phase 2 Phase 3

Detailed Description:

The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.

All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.

All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.

The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lower Uterine Compression Sutures for the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis; Prospective Study
Study Start Date : July 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: all patients
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
Procedure: lower uterine compression sutures
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.




Primary Outcome Measures :
  1. Treatment of Postpartum Hemorrhage [ Time Frame: during cesarean section( participants will be followed for the duration of hospital stay) ]

Secondary Outcome Measures :
  1. evaluation of uterine cavity [ Time Frame: 6 months after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a gestation age of ≥ 28 weeks and antepartum hemorrhage;
  • intraoperative postpartum hemorrhage and discovery of a placenta previa;
  • successful removal of the placenta

Exclusion Criteria:

  • shock due to massive blood loss
  • failure of successful removal of the placenta

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): NCT02157441


Locations
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Egypt
Benha univesity hospital
Benha, El Qualyobia, Egypt, 13518
Sponsors and Collaborators
Benha University
Investigators
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Study Chair: khalid mohamed, MD Department of Obstetrics and Gynecology, Benha University Hospital

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Responsible Party: khalid abd aziz mohamed, lecturer of ob/gyn, Benha University
ClinicalTrials.gov Identifier: NCT02157441     History of Changes
Other Study ID Numbers: khalid-ahmed 4
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by khalid abd aziz mohamed, Benha University:
Postpartum Hemorrhage
Placenta Previa
uterine cavity

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Placenta Previa
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases