Completed

Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

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What is being tested

Laminaria, MedGyn Products, Inc. USA.

+ Misoprostol

DeviceDrug
Who is being recruted

From 15 to 45 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2007
See protocol details

Summary

Principal SponsorWolfson Medical Center
Last updated: September 5, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2007

Actual date on which the first participant was enrolled.

This is a prospective randomized study. The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol. Primary outcome measures will include: Initial cervical opening and the need for further dilatation at the procedure Procedure duration Difficulty score performing the abortion Complications during and after the procedure Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure

NCT01678703
Principal SponsorWolfson Medical Center
Last updated: September 5, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 15 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Admitted for termination of pregnancy
Pregnancy 14-20 weeks of gestation
Pregnant patients with a viable singleton
6 exclusion criteria prevent from participating
Contraindication for administration of Misoprostol
Non viable pregnancy
Patients with impaired coagulation
Patients with more than one previous cesarean section scar
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion

Group II

Active Comparator
Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Edith Wolfson Medical Center

Holon, IsraelOpen Edith Wolfson Medical Center in Google Maps
CompletedOne Study Center