Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
NCT ID: NCT01678703
Last Updated: 2012-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2007-11-30
2010-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laminaria group
Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion
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.
Misoprostol group
Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Misoprostol
Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Interventions
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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.
Misoprostol
Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnancy 14-20 weeks of gestation
* Admitted for termination of pregnancy
Exclusion Criteria
* 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
15 Years
45 Years
FEMALE
No
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ron Sagiv, MD
Role: STUDY_DIRECTOR
Tel Aviv University, Sackler Medical School, Israel
Locations
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Edith Wolfson Medical Center
Holon, , Israel
Countries
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Other Identifiers
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2trimabort.CTIL
Identifier Type: -
Identifier Source: org_study_id