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

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590484
• Other study ID #: MUH14367
• 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
• 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

Related Conditions & MeSH terms

• Placenta Previa
• Placenta Previa Accreta
• Postpartum Hemorrhage

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