Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04193345 |
| Other study ID # |
MD-74-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To compare the different maternal and neonatal impacts of early versus delayed umbilical cord
clamping among pregnant preeclamptic patients delivered by cesarean section
Description:
The study will include 62 pregnant women attending for severe preeclampsia and cesarean
delivery will be done at the Kasr Elaini hospital (faculty of medicine - Cairo university).
Informed written consent: after discussing the nature of the study as well as the expected
value, outcome, and possible adverse effects.
Full medical history: including full obstetric history and current pregnancy history
(entailing the 1st day of LMP).
Thorough Clinical Examination: general (maternal body weight and vital signs) and full
obstetric examination.
Obstetric ultrasonography: to confirm gestational age and the eligibility of the current
pregnancy to participate in the study.
Preoperative laboratory tests: including prothrombin time, prothrombin concentration,
complete blood count, and liver and kidney function tests.
Group allocation: On the day of the scheduled surgery, participants will be randomly and
equally assigned into two groups; early clamping group n= 31 ( umbilical cord to be clamped
within 15 s ) and delayed clamping group , n= 31 ( umbilical cord to be clamped at 60 sec ) ,
In all groups , Neonates will be held in a sterile towel or blanket below the level of the
incision on maternal abdomen or between her legs at cesarean section. Care was taken that no
tension or traction was placed on the cord. A stopwatch was used to mark the time , patients
will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland)
and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h)
following the delivery of the baby All cesarean sections will be done under spinal anesthesia
by an assistant lecturer and the following operative steps: pfannenstiel incision, transverse
lower uterine segment incision, early cord clamping (< 15 seconds) or delayed cord clamping
(after 60 sec) and the placenta will be removed by controlled cord traction after its
spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in
anatomical manner (adequate hemostasis will be ensured in all operative steps).
The number and the difference of weight of operative towels (before and after LSCS) and
amount of blood in suction unit will be recorded.
A complete blood count test will be performed 12 hours after delivery. neonatal laboratory
results (hemoglobin and hematocrit, )will be collected within 4 hours of age, initial serum
bilirubin was collected at 12 hours of age then to be repeated at day 3 for follow up.
Estimated Blood Loss (EBL) will be evaluated as follows:
A. The number of operative towels used. B. The difference of weight of operative towels
(before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of
weight difference equal to 1 ml blood loss).
C. EBL calculation according to the following formula:
EBL= EBV x Preoperative hematocrit- Postoperative hematocrit Postoperative hematocrit Where
EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
The neonates clinical data, as APGAR Score, blood pressure, temperature, jaundice, pallor and
cyanosis and respiratory distress syndrome will be collected by the attending neonatologist
.All patients will be followed up following the delivery as regard occurrence of primary
postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the
first 24 hours).
