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

Not Applicable

• Conditions: Placenta Previa Accreta; Placenta Previa

• Registration Number: NCT02590484
• Lead Sponsor: Minia University

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 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 Timeline

• Study Start: 2012-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Study First Posted: 2015-10-29
• Last Update Posted: 2015-10-29
• Primary Completion: 2017-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful control of postpartum haemorrhage (PPH)	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	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	short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, Minia University Hospital; 🇪🇬 Minia, Egypt