NCT01678703

Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol. The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria. The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.

Detailed description

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

Conditions

• Induced; Abortion, Nonmedical

Interventions

Type	Name	Description
DEVICE	Laminaria, MedGyn Products, Inc. USA.	Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.
DRUG	Misoprostol	Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2012-09-05
• Last updated: 2012-09-05

Locations

1 site across 1 country: Israel