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

Not Applicable

• Conditions: Other Abortion
• Interventions: Drug: Cytotec

• Registration Number: NCT02013960
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2013-09-16
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17
• Study Start: 2014-01
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Second trimester pregnancy No evidence of chorioamnionitis

Exclusion Criteria

Allergy to misoprostol. Evidence for infection. Asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria	Cytotec	cytotec and laminaria
Cytotec	Cytotec	Cytotec only

Primary Outcome Measures

Name	Time	Method
Duration of time until pregnancy termination	Average time 12 hours	From the time of receiving the treatment until complete abortion

Trial Locations

Locations (1)

Rambam Health Campus; 🇮🇱 Haifa, Israel