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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01678703
First received: August 22, 2012
Last updated: August 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Induced; Abortion, Nonmedical
 Device: Laminaria, MedGyn Products, Inc. USA.
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Initial cervical opening and the need for further dilatation at the start of the procedure [ Time Frame: 8-12 hours after insersion of laminaria or Misoprostol ] [ Designated as safety issue: Yes ]
    The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol


Secondary Outcome Measures:
  • pain score during cervical preparation and after the procedure [ Time Frame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia ] [ Designated as safety issue: No ]

    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



Other Outcome Measures:
  • The degree of difficulty to accomplish the abortion [ Time Frame: at the time of performing the surgical abortion ] [ Designated as safety issue: No ]
    The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.


Enrollment: 84
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cytotec

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

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678703

Locations
Israel
Edith Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Study Director: Ron Sagiv, MD Tel Aviv University, Sackler Medical School, Israel
  More Information

No publications provided

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01678703     History of Changes
Other Study ID Numbers: 2trimabort.CTIL
Study First Received: August 22, 2012
Last Updated: August 30, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
late abortion
laminaria
Misoprostol
Cervical preparation

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013