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Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.
400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.
The recruited patients will be subjected to the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin before placental delivery | Experimental | patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta. |
|
| oxytocin after placental delivery | Experimental | patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | Ecbolic used to reduce blood loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood loss in vaginal delivery | blood loss in the third stage of labor (Up to 60 min after delivery of the baby) |
| Measure | Description | Time Frame |
|---|---|---|
| primary postpartum hemorrhage | within 24 hours after delivery | |
| changes in hemoglobin and hematocrit | before delivery and after 6 hours | |
| retained placenta |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reham Marie, MRCOG | Contact | +201212977339 | rehamfarghal84@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr Yehia, MD, MRCOG | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| C014635 | lactitol |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| more than 30 minutes after delivery |
| length of 3rd stage of labor | Up to 60 min from delivery of baby till delivery of placenta |
| manual removal of the placenta | if not separated after 30 minutes from delivery |
| blood pressure | to be measured before delivery after 15 minutes,1 hour,6 hours |
| maternal pain | during third stage of labor |
| maternal nausea and vomiting | during 3rd stage of labor |
| secondary postpartum hemorrhage | after 24 hours and before 6 weeks from delivery |
| surgical intervention to stop the bleeding | within 24 hours after delivery |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |