Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

Conditions
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Retained Placenta

Intervention / Treatment
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* Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old and older medical pregnancy termination between 14 and 28 weeks gestation informed consent obtained Exclusion Criteria: less than 18 years old refusal to consent in utero fetal death

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin administration after fetal expulsion<br>Administration of 10 units of intra venous oxytocin after fetal expulsion | Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion<br> <br> |
| No Intervention: No additional medication after fetal expulsion<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of placental retention |  | Up to 30 minutes after fetal expulsion | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retained Placenta, Second trimester medical termination, Third stage labor, Oxytocin