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

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.

Study Overview

• Status: Completed
• Conditions: Induced; Abortion, Nonmedical
• Intervention / Treatment: Device: Laminaria, MedGyn Products, Inc. USA.; Drug: Misoprostol

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 58100
    • Edith Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laminaria group; Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion	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.; Other Names: laminaria tents
Active Comparator: Misoprostol group; Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion	Drug: Misoprostol; Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion; Other Names: Cytotec

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score during cervical preparation and after the procedure	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	at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of difficulty to accomplish the abortion	The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.	at the time of performing the surgical abortion

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Study Director: Ron Sagiv, MD, Tel Aviv University, Sackler Medical School, Israel

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): September 5, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: August 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Misoprostol; laminaria; Cervical preparation; late abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 2trimabort.CTIL