Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
Overview
- Phase
- Not Applicable
- Intervention
- Laminaria, MedGyn Products, Inc. USA.
- Conditions
- Induced; Abortion, Nonmedical
- Sponsor
- Wolfson Medical Center
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Initial cervical opening and the need for further dilatation at the start of the procedure
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility 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
Arms & Interventions
Laminaria group
Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion
Intervention: Laminaria, MedGyn Products, Inc. USA.
Misoprostol group
Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Intervention: Misoprostol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- pain score during cervical preparation and after the procedure(at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia)