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

Primary Purpose

Placenta Previa, Placenta Previa Accreta

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The cervix as a natural tamponade (cervical inversion)
Sponsored by
Minia University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Previa

Eligibility Criteria

18 Years - 40 Years (Adult)Female

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.

Sites / Locations

  • Department of Obstetrics and Gynaecology, Minia University HospitalRecruiting

Outcomes

Primary Outcome Measures

Successful control of postpartum haemorrhage (PPH)
Control of PPH and vaginal bleeding after employing the technique
Number of cases undergoing hysterectomy to control PPH
Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding
Incidence of complications

Secondary Outcome Measures

Full Information

First Posted
October 27, 2015
Last Updated
October 28, 2015
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT02590484
Brief Title
The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta
Official Title
The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa, Placenta Previa Accreta

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
The cervix as a natural tamponade (cervical inversion)
Other Intervention Name(s)
Dawlatly stitch, cervical inversion
Intervention Description
Suturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding.
Primary Outcome Measure Information:
Title
Successful control of postpartum haemorrhage (PPH)
Description
Control of PPH and vaginal bleeding after employing the technique
Time Frame
Intra-operative and up to 24 hours postpartum
Title
Number of cases undergoing hysterectomy to control PPH
Description
Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding
Time Frame
Intra-operative and up to 24 hours postpartum
Title
Incidence of complications
Time Frame
short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Eligibility Criteria
Inclusion Criteria: All participating women had one or more previous cesarean deliveries. 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. All participating women desired to preserve their fertility Patients with focal (partial) placenta previa accreta/ placenta previa. Exclusion Criteria: placenta percreta. diffuse placenta accreta or increta. uncontrollable postpartum hemorrhage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed R Abdelraheim, MD, MRCOG
Phone
+201096860338
Email
arabdelraheim@yahoo.com
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology, Minia University Hospital
City
Minia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelraheim, MD, MRCOG
Phone
+201096860338
Email
arabdelraheim@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31455286
Citation
El Gelany S, Mosbeh MH, Ibrahim EM, Mohammed M, Khalifa EM, Abdelhakium AK, Yousef AM, Hassan H, Goma K, Alghany AA, Mohammed HF, Azmy AM, Ali WA, Abdelraheim AR. Placenta Accreta Spectrum (PAS) disorders: incidence, risk factors and outcomes of different management strategies in a tertiary referral hospital in Minia, Egypt: a prospective study. BMC Pregnancy Childbirth. 2019 Aug 27;19(1):313. doi: 10.1186/s12884-019-2466-5.
Results Reference
derived
PubMed Identifier
30922265
Citation
El Gelany S, Ibrahim EM, Mohammed M, Abdelraheim AR, Khalifa EM, Abdelhakium AK, Yousef AM, Hassan H, Goma K, Khairy M. Management of bleeding from morbidly adherent placenta during elective repeat caesarean section: retrospective -record -based study. BMC Pregnancy Childbirth. 2019 Mar 29;19(1):106. doi: 10.1186/s12884-019-2244-4.
Results Reference
derived
PubMed Identifier
26559634
Citation
El Gelany SA, Abdelraheim AR, Mohammed MM, Gad El-Rab MT, Yousef AM, Ibrahim EM, Khalifa EM. The cervix as a natural tamponade in postpartum hemorrhage caused by placenta previa and placenta previa accreta: a prospective study. BMC Pregnancy Childbirth. 2015 Nov 11;15:295. doi: 10.1186/s12884-015-0731-9.
Results Reference
derived

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

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