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

Rambam Health Care Campus

Status: Unknown

Conditions: Other Abortion

Treatments: Drug: Cytotec

Study type: Interventional

Funder types: Other

Identifiers

NCT02013960

0099-13-RMB CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Second trimester pregnancy No evidence of chorioamnionitis

Exclusion criteria

Allergy to misoprostol. Evidence for infection. Asthma

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Laminaria

Experimental group

Description:

cytotec and laminaria

Treatment:

Drug: Cytotec

Cytotec

Active Comparator group

Description:

Cytotec only

Treatment:

Drug: Cytotec