An interventional study of Novel Technique of Placenta Accreta in Menoufia University Hospital in Placenta Accreta, sponsored by Menoufia Obstetrics and Gynecology Group. Completed at 2 sites in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Menoufia Obstetrics and Gynecology Group · Not applicable, Interventional, and Treatment
Evaluation of maternal morbidity and mortality of our novel surgical procedure for conservative management of placenta accreta in our tertiary referral institute.
A descripative cohort study which included 60 pregnant women recuirted from Obstetrics and Gynecology Department, Menoufia University Hospital and diagnosed as placenta previa accreta.
Consent: after explanation of surgical procedure of the study, an informed written consent was obtained from all cases included in this study.
Sample size: (No= 60) Based on previous studies regarding MAP, The incidence of placenta accreta = 1/2500 , so the calculated sample size for this study was 59 which to be around 60 with confidence level 95% margin of error 5% (Pliskow S et al., 2009).
Inclusion criteria:
Any patient diagnosed as placenta previa with ultrasound criteria of accretion.
Criteria of accretion by Colour Doppler ultrasound include: (Berkley et al., 2013).
I. Detailed history taking:
II. Clinical examination:
General examination:
Abdominal examination :
Inspection :
Size, shape, pigmentation (linea nigra),stria gravidarum and scars (like cesarean section scars).
Palpation:
To detect tenderness, rigidity and fundal level.
Auscultation:
Fetal heart sounds.
III. Investigations :
Fetal observation : transabdominal pelvic ultrasound was performed to detect fetal presentation, lie, viability ( by observation of fetal heart movement), gestational age by measuring biparital diameter, femur length and abdominal circumference) and fetal weight.
Placenta observation : site (anterior or posterior), position in realtion to internal os to determine type of placenta previa and colour Doppler to determine grade of accretion ( accrete, increta, percreta and focal aacretion) and criteria of accretion.
Surgical Procedure:
Uterine conservation required multidisciplinary team including the obstetrician, anasethetist and urologist in certain cases.
Operative Steps:
Outcome variables:
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Menoufia Obstetrics and Gynecology Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
1- Age between 20 - 40 years old. 2- Gestational age between 28 - 38 weeks. 3- Any patient diagnosed as placenta previa with ultrasound criteria of accretion.
Criteria of accretion by Colour Doppler ultrasound include: (Berkley et al., 2013).
Exclusion Criteria:
of 60 pregnant female diagnosed as placenta previa accreta recuirted from Obstetrics and Gynecology Department , Menoufia University Hospital.
Procedure: Novel Technique of Placenta Accreta in Menoufia University Hospital
* Classical CS to decrease haemorrhage from placental bed. * Delievery of the fetus. * At the delivery 10 UI of oxytocin IV will be injected. * The placenta is not attempted to be delievered. * Opening of the broad ligament via round ligament division and ligation. * Gentle dissection of the urinary bladder from lateral to medial. * Bilateral uterine artery clamping at low level below the placental bed . * Gentle attempt to deliver The placenta. * If the placenta is delievered we will do bilateral uterine artery ligation at multiple levels and multiple square compression sutures(if needed) for proper hemeostasis at the placental bed. Then closure of uterine incision. * If the placenta is not delievered we will do segmental ressection of lower uterine segment including the placenta . * Intraperitoneal drain insertion.
Outcome variables: Need for conversion to hysterectomy.
control of bleeding and need for removal of uterus.
Time frame: 30- 90 minutes
Blood Loss.
Amount of blood loss ,Number of packed red blood cells and blood products transfusion.
Time frame: During operation and 24 hours postpartum.
Intraoperative complications
urinary bladder injury, ureteric injury. Postoperative complications e.g ileus, sepsis
Time frame: During operation and postpartum period.
Plan to share: No
Ran from Nov 2018 to primary completion in Nov 2019, 12 months.
Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Menoufia Obstetrics and Gynecology Group