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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

Conditions
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Induced; Abortion, Nonmedical

Intervention / Treatment
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* Device: Laminaria, MedGyn Products, Inc. USA.
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laminaria group<br>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.<br>* 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.<br>* Other names: laminaria tents;|
| Active Comparator: Misoprostol group<br>Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion | Drug: Misoprostol<br>* Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late abortion, laminaria, Misoprostol, Cervical preparation