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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02590484
Other study ID # MUH14367
Secondary ID
Status Recruiting
Phase N/A
First received October 27, 2015
Last updated October 28, 2015
Start date June 2012
Est. completion date May 2018

Study information

Verified date October 2015
Source Minia University
Contact Ahmed R Abdelraheim, MD, MRCOG
Phone +201096860338
Email arabdelraheim@yahoo.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2017
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design

Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
Egypt Department of Obstetrics and Gynaecology, Minia University Hospital Minia

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful control of postpartum haemorrhage (PPH) Control of PPH and vaginal bleeding after employing the technique Intra-operative and up to 24 hours postpartum
Primary Number of cases undergoing hysterectomy to control PPH Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding Intra-operative and up to 24 hours postpartum
Primary Incidence of complications short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum
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