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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Minia University

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Minia University

Dates:
Date Received: October 27, 2015
Date Started: June 2012
Date Completion: May 2018
Last Updated: October 28, 2015
Last Verified: October 2015