Induced; Abortion, Nonmedical Clinical Trial
Official title:
Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
| Verified date | July 2012 |
| Source | Wolfson Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 15 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Edith Wolfson Medical Center | Holon |
| Lead Sponsor | Collaborator |
|---|---|
| Wolfson Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Primary | 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 | Yes |
| Secondary | 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 | No |