Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

Other Abortion Clinical Trial

Official title:

Comparison Between Sublingual Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02013960
• Other study ID #: 0099-13-RMB CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 16, 2013
• Last updated: December 11, 2013
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

1. Comparison between the duration of time from the beginning of cervical preparation until abortion, between sublingual misoprostol and the combination of sublingual misoprostol with laminaria for second trimester medical termination of pregnancy (TOP).

2. Comparison between the adverse event rate following Sublingual misoprostol only vs. Sublingual misoprostol and laminaria given for pregnancy termination.

3. Comparison between the levels of satisfaction rate of women who underwent pregnancy termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.

Description:

A prospective randomized control trial; 50 women undergoing pregnancy termination in the second trimester (14-28 weeks)in each group.

Following receiving an ethical approval by the local institutional review board (IRB), committee, consecutively all women in between 14 weeks to 28 weeks; that have a reason for termination of pregnancy like: intrauterine fetal death or medical or genetic indications for termination of pregnancy or socioeconomic termination of pregnancy will be offered to take part in the study. If eligible according to the inclusion and exclusion criteria, women will be asked to sign a consent form.

All participants will undergo blood exams (CBC, Prothrombin time, Partial thromboplastin time , and BLOOD TYPING) and ultrasound exam for Confirmation of diagnosis as routinely indicated for missed abortion at our department

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Second trimester pregnancy No evidence of chorioamnionitis

Exclusion Criteria:

Allergy to misoprostol. Evidence for infection. Asthma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Other Abortion

Intervention

Drug:
• Cytotec
Cytotec medication compared with cytotec and laminaria

Locations

Country	Name	City	State
Israel	Rambam Health Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of time until pregnancy termination	From the time of receiving the treatment until complete abortion	Average time 12 hours	No