Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Incidence of placental retention
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Oxytocin administration after fetal expulsion
Administration of 10 units of intra venous oxytocin after fetal expulsion
Intervention: Administration of 10 units of intra venous oxytocin after fetal expulsion (Drug)
Outcomes
Primary Outcomes
Incidence of placental retention
Time Frame: Up to 30 minutes after fetal expulsion
Secondary Outcomes
- 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)