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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laminaria group | Active Comparator | Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion |
|
| Misoprostol group | Active Comparator | Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Sagiv, MD | Tel Aviv University, Sackler Medical School, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Wolfson Medical Center | Holon | 58100 | Israel |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| Misoprostol | Drug | Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion |
|
|
| at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |