Completed

NCT Number: NCT01678703

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induced; Abortion, Nonmedical

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edith Wolfson Medical Center

Holon, 58100, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: laminaria tents

Misoprostol

Drug

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

Other names: Cytotec

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

Time frame: 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 outcomes

The degree of difficulty to accomplish the abortion

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Sep 5, 2012
Registry last updated: Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.