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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003143-11 | EudraCT Number |
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Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.
Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin administration after fetal expulsion | Experimental | Administration of 10 units of intra venous oxytocin after fetal expulsion |
|
| No additional medication after fetal expulsion | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of 10 units of intra venous oxytocin after fetal expulsion | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of placental retention | Up to 30 minutes after fetal expulsion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of partial placental retention | Up to 1 hour after fetal expulsion | |
| Incidence of digital exploration | Up to 1 hour after fetal expulsion | |
| Incidence of blunt curettage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D018457 | Placenta, Retained |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Up to 1 hour after fetal expulsion |
| Incidence of post-partum hemorrhage | Up to 1 hour after fetal expulsion |
| Blood loss | Up to 1 hour after fetal expulsion |