Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta

NCT ID: NCT02878187

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-15
• Study Completion Date: 2020-05-31

Brief Summary

Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation

Detailed Description

No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Conditions

Improving Quality of Life

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

placenta previa

all women managed by conservative surgical techniques during cesarean section after intraoperative hemorrhage due to placenta previa/accreta

Doppler

Intervention Type: DEVICE

Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:

The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum

healthy controls

women delivered by Cesarean for any other indication with no intraoperative hemorrhage or any additional surgical techniques performed during Cesarean

Doppler

Intervention Type: DEVICE

Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:

The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum

Interventions

Doppler

Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:

The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Women Age 18-40 years

2. Gestational age of pregnancy 28-40 weeks

3. Diagnosed antenatally as placenta previa/accreta

4. Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage

5. Women who will accept to participate in the study and are reliable for follow-up

Exclusion Criteria

• 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abbas, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

PP

Identifier Type: -

Identifier Source: org_study_id