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

October 28, 2015 updated by: Ahmed Rabie Abdelraheim, Minia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minia, Egypt
        • Recruiting
        • Department of Obstetrics and Gynaecology, Minia University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intra-operative and up to 24 hours postpartum
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
Intra-operative and up to 24 hours postpartum
Incidence of complications
Time Frame: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum
short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUH14367

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.

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