Atonic Postpartum Hemorrhage, High Risk Pregnancy
Conditions
Keywords
Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy
Brief summary
Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.
Detailed description
Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously. The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.
Interventions
DRUGOxytocin
10 iu will be given intravenously.
DRUGCarbetocin
100 micrograms will be given intravenously.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patient will be blinded to the drug to be used
Intervention model description
Randomized Clinical Trial (Simple randomization)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following: 1. History of postpartum hemorrhage. 2. Delivery of a macrosomic baby (\> 4000 g). 3. Multiple gestation. 4. Polyhydramnios. 5. Grand Multiparity. 6. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata) 7. Chorioamnionitis.
Exclusion criteria
* • Patients without high risk for post-partum hemorrhage. * Patients at high risk for postpartum hemorrhage but will deliver vaginally. * Patients with medical disorders complicating pregnancy. * Patients with coagulation defects. * Preterm pregnancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Postpartum Hemorrhage | First 24 hours after Delivery | Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood. |
Contacts
Primary ContactEman M Sabry, MBBCh
Backup ContactAmr O Abdelkareem, MD
Outcome results
None listed