Misoprostol for Second Trimester Pregnancy Termination

Intra Uterine Fetal Death Clinical Trial

— MIS  

Official title:

Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669420
• Other study ID #: 220
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2016
• Last updated: January 27, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnancy 13-24 weeks.

• Women with indication for termination of the pregnancy due to intra uterine fetal death

Exclusion Criteria:-Pregnancy before 13 weeks.

• Pregnancy beyond 24 weeks.

• Women with scared uterus.

• Known hypersensitivity for misoprostol.

• Refusal of the woman to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Death
• Intra Uterine Fetal Death

Intervention

Procedure:
• termination of second trimester pregnancy
Intra uterine extra amniotic (200 µg ) versus Vaginal (200 µg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean duration from the initial misoprostol dose until complete fetal expulsion		24 hours	Yes