Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
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|ClinicalTrials.gov Identifier: NCT01678703|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 5, 2012
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 or disease||Intervention/treatment||Phase|
|Induced; Abortion, Nonmedical||Device: Laminaria, MedGyn Products, Inc. USA. Drug: Misoprostol||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Other Name: Cytotec
- 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 ]The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol
- 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 ]
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
- The degree of difficulty to accomplish the abortion [ Time Frame: at the time of performing the surgical abortion ]The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678703
|Edith Wolfson Medical Center|
|Holon, Israel, 58100|
|Study Director:||Ron Sagiv, MD||Tel Aviv University, Sackler Medical School, Israel|