PDIUC Protocol for Placental Accreta

Placenta Accreta Clinical Trial

— PDIUC  

Official title:

Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03273569
• Other study ID #: PDIUC001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 5, 2017
• Last updated: September 4, 2017
• Start date: October 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Sherif Shazly, MBBCh, MSc
• Phone: +15075131392
• Email: sherify2k2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.

Description:

Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with diagnosis of placenta accreta (US or MRI based diagnosis)

• Women who decline hysterectomy

• Pregnancy at 28 weeks of gestation or beyond

• Women who accept to participate in the study

Exclusion Criteria:

• Emergency Cesarean delivery (women with active bleeding)

• Women with cardiac diseases

• Women with coagulopathy

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• PDI-UC protocol
Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine conservation	Successive Uterine conservation; no peripartum hysterectomy needed	Intra-operative (during the time of Cesarean delivery)
Secondary	Primary postpartum hemorrhage	Amount of postpartum bleeding > 1000 ml	From delivery of the fetus to 1 hour after delivery of the fetus
Secondary	Severe primary postpartum hemorrhage	Amount of postpartum bleeding > 1500 ml	From delivery of the fetus to 1 hour after delivery of the fetus
Secondary	Bladder injury	Incidental injury of the bladder during delivery of the placenta or control of bleeding	Intra-operative (during the time of Cesarean delivery)
Secondary	Bowel injury	Incidental injury of the bladder during delivery of the placenta or control of bleeding	Intra-operative (during the time of Cesarean delivery)
Secondary	Surgical site infection	Cesarean wound infection	Up to 2 weeks after Cesarean delivery
Secondary	Drop in hemoglobin level	Change in hemoglobin before and more than 24 hours after delivery	Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)