The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Placenta Previa Placenta Previa Accreta||Procedure: The cervix as a natural tamponade (cervical inversion)||Not Applicable|
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 (Clinical Trial)|
|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|
- 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
- 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 ]
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
|Contact: Ahmed R Abdelraheim, MD, MRCOGemail@example.com|
|Department of Obstetrics and Gynaecology, Minia University Hospital||Recruiting|
|Contact: Ahmed Abdelraheim, MD, MRCOG +201096860338 firstname.lastname@example.org|