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

University Hospital of Bordeaux

Status and phase: Completed; Phase 4

Conditions: Retained Placenta

Treatments: Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT02969447

CHUBX 2016/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Oxytocin administration after fetal expulsion

Experimental group

Description:

Administration of 10 units of intra venous oxytocin after fetal expulsion

Treatment:

Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion

No additional medication after fetal expulsion

No Intervention group