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

Not Applicable

Completed

• Conditions: Induced; Abortion, Nonmedical
• Interventions: Device: Laminaria, MedGyn Products, Inc. USA.; Drug: Misoprostol

• Registration Number: NCT01678703
• Lead Sponsor: Wolfson Medical Center

Brief 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

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-07
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-30
• Last Update Submitted: 2012-08-30
• Study First Posted: 2012-09-05
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Pregnant patients with a viable singleton
• Pregnancy 14-20 weeks of gestation
• Admitted for termination of pregnancy

Exclusion Criteria

• Contraindication for administration of Misoprostol
• Patients with more than one previous cesarean section scar
• Patients with impaired coagulation
• Significant pulmonary or cardiac disease
• Non viable pregnancy
• Placenta accreta or previa by ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria group	Laminaria, MedGyn Products, Inc. USA.	Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion
Misoprostol group	Misoprostol	Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Primary Outcome Measures

Name	Time	Method
Initial cervical opening and the need for further dilatation at the start of the procedure	8-12 hours after insersion of laminaria or Misoprostol	The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol

Secondary Outcome Measures

Name	Time	Method
pain score during cervical preparation and after the procedure	at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia	The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol.; Pain score will be recorded again right before performing the abortion and will address the 8-12 hours elapsed from the insertion.; Another assessment of pain will be recorded immediately after the abortion following recovery from general anesthesia

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel