Induced; Abortion, Nonmedical
Conditions
Keywords
late abortion, laminaria, Misoprostol, Cervical preparation
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
Interventions
DEVICELaminaria, 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.
DRUGMisoprostol
Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial cervical opening and the need for further dilatation at the start of the procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The degree of difficulty to accomplish the abortion | 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. |
Countries
Israel
Outcome results
None listed