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Postpartum hemorrhage [PPH] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.
The American College of Obstetricians and Gynecologists (ACOG) updated their definition of postpartum hemorrhage (PPH) to be "blood loss greater than or equal to 1000 ml or blood loss accompanied by signs or symptoms of hypovolemia" .
Recent clinical and translational studies have suggested a decrease in uterine contractility among obese and morbidly obese women as a primary cause of obstetric hemorrhage.
In the United States, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese. A panel of obstetric experts has speculated that the rising prevalence of maternal obesity in developed countries may explain the increase in postpartum hemorrhage incidence.
Uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage (PPH) after Cesarean delivery.
There are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin. Carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).
The investigators aim to investigate the impact of carbetocin on uterine contractility in obese versus non-obese pregnant women undergoing elective cesarean delivery following carbetocin 100 mcg bolus IV administration as a prophylaxis of postpartum hemorrhage in a randomized controlled trial. The incestigators hypothesize that increased volume of distribution reduces the bioavailability of carbetocin and may be an explanation for reduced efficacy. Also the investigators will examine uterine tone as a surrogate marker for the bioavailability of carbetocin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Parturient with BMI ≥ 30 kg/m2. | Active Comparator | All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [PabalVR, Ferring AG, Baar, Switzerland]). |
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| Group B: Parturients with BMI < 30kg/m2 (control group) | Other | All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [Pabal, Ferring , Baar, Switzerland]). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin 100 Microgram/mL Solution for Injection | Drug | All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [PabalVR, Ferring AG, Baar, Switzerland]).then assess uterine contractility and postpartum bleeding measuring |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood loss (ml) at cesarean section | Estimation of blood loss will be by assessing difference between pre -operative hemoglobin and a 24 hours after delivery hemoglobin and pre and 24h after delivery hematocrit according to the following formula: Estimated blood volume (pre-operative Hct-postoperative Hct)/pre-operative Hct. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine contractility and the need for more doses of carbetocin | Uterine contractility, the proportion of women receiving additional uterotonics after administration of single dose of carbetocin, transfusion of blood products and use of non-drug measures to treat PPH. | 3 months |
| Estimated Blood loss by weighing gauze towel |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaimaa El Shemy | Giza | Cairo Governorate | 11562 | Egypt |
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| ID | Term |
|---|---|
| D000079262 | Pregnancy in Obesity |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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weighing gauze towels (grams)pre and postoperative. Using suction when amniotic fluid membranes rupture up to delivery of the placenta. Gauze towels will be used exclusively to mop up the blood until closure of the abdomen |
| 3 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007744 | Obstetric Labor Complications |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |