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

Wolfson Medical Center84 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Induced; Abortion, Nonmedical

Interventions

Laminaria, MedGyn Products, Inc. USA.DEVICE

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.

MisoprostolDRUG

Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Edith Wolfson Medical Center

Holon, Israel

Outcomes

Primary Outcomes

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

Time frame: 8-12 hours after insersion of laminaria or Misoprostol

Secondary Outcomes

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

Time frame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia

Data from ClinicalTrials.gov

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