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

Retained Placenta Clinical Trial

— ANDDROID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969447
• Other study ID #: CHUBX 2016/20
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2016
• Last updated: October 3, 2017
• Start date: October 20, 2016
• Est. completion date: August 4, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 4, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Placenta, Retained
• Retained Placenta

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of placental retention		Up to 30 minutes after fetal expulsion
Secondary	Incidence of partial placental retention		Up to 1 hour after fetal expulsion
Secondary	Incidence of digital exploration		Up to 1 hour after fetal expulsion
Secondary	Incidence of blunt curettage		Up to 1 hour after fetal expulsion
Secondary	Incidence of post-partum hemorrhage		Up to 1 hour after fetal expulsion
Secondary	Blood loss		Up to 1 hour after fetal expulsion