the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis

Placenta Previa Complete Centralis Clinical Trial

— PPH  

Official title:

Lower Uterine Compression Sutures for the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis; Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157441
• Other study ID #: khalid-ahmed 4
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 3, 2014
• Last updated: October 9, 2015
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles

Description:

The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.

All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.

All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.

The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 46 Years

Eligibility

Inclusion Criteria:

• a gestation age of = 28 weeks and antepartum hemorrhage;

• intraoperative postpartum hemorrhage and discovery of a placenta previa;

• successful removal of the placenta

Exclusion Criteria:

• shock due to massive blood loss

• failure of successful removal of the placenta

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Placenta Previa
• Placenta Previa Complete Centralis
• Postpartum Hemorrhage

Intervention

Procedure:
• lower uterine compression sutures
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.

Locations

Country	Name	City	State
Egypt	Benha univesity hospital	Benha	El Qualyobia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of Postpartum Hemorrhage		during cesarean section( participants will be followed for the duration of hospital stay)	Yes
Secondary	evaluation of uterine cavity		6 months after delivery	Yes