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

Wolfson Medical Center (WMC)

Status: Completed

Conditions: Induced; Abortion, Nonmedical

Treatments: Device: Laminaria, MedGyn Products, Inc. USA.; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01678703

2trimabort.CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Laminaria group

Active Comparator group

Description:

Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion

Treatment:

Device: Laminaria, MedGyn Products, Inc. USA.

Misoprostol group

Active Comparator group

Description:

Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion

Treatment:

Drug: Misoprostol