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

NCT01678703 | Completed DMC

• 1 other identifier: 2trimabort.CTIL
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced; Abortion, Nonmedical

Keywords

late abortion; laminaria; Misoprostol; Cervical preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• The degree of difficulty to accomplish the abortion

  at the time of performing the surgical abortion

Study Arms (2)

Laminaria group

ACTIVE COMPARATOR

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.

Misoprostol group

ACTIVE COMPARATOR

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

Drug: Misoprostol

Interventions

Laminaria, MedGyn Products, Inc. USA. DEVICE

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.

Also known as: laminaria tents

Laminaria group

Misoprostol DRUG

Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Also known as: Cytotec

Misoprostol group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ron Sagiv, MD

  Tel Aviv University, Sackler Medical School, Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: September 5, 2012
• Study Start: November 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 5, 2012

Record last verified: 2012-07

Locations

IL (1)