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

NCT ID: NCT02013960

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Other Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Laminaria

cytotec and laminaria

Group Type EXPERIMENTAL

Cytotec

Intervention Type DRUG

Cytotec medication compared with cytotec and laminaria

Cytotec

Cytotec only

Group Type ACTIVE_COMPARATOR

Cytotec

Intervention Type DRUG

Cytotec medication compared with cytotec and laminaria

Interventions

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Cytotec

Cytotec medication compared with cytotec and laminaria

Intervention Type DRUG

Other Intervention Names

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Misorpristol vs. Misopristol and laimnria

Eligibility Criteria

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Inclusion Criteria

Second trimester pregnancy No evidence of chorioamnionitis

Exclusion Criteria

Allergy to misoprostol. Evidence for infection. Asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Awad Nibal MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nibal Awad, MD

Role: STUDY_CHAIR

Rambam Health Care Campus

Locations

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Rambam Health Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0099-13-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id