Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Abortion, Induced Clinical Trial

Official title:

Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02480543
• Other study ID #: 0085-15-WOMC
• Status: Recruiting
• Phase: Phase 4
• First received: June 20, 2015
• Last updated: April 28, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: Wolfson Medical Center
• Contact: Hadas Ganer Herman, MD
• Phone: 972-077-2066960
• Email: hadassganer[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age <13+0 weeks

• Written consent supplied

Exclusion Criteria:

• Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)

• Prostaglandin allergy

• Genital infection

• Space-occupying lesion in the endocervical canal

• Prior cervical surgery

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• Misoprostol (cytotec)

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative cervical width in centimeters	• Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.	intraoperative
Secondary	Time required to achieve cervical dilatation	The time in minutes required for dilatation up to a number 10 Hegar	intraoperative
Secondary	Ease of cervical dilatation	The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy	intraoperative
Secondary	Patient preference	Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)	baseline
Secondary	Adverse effects of medication	Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)	baseline
Secondary	Surgical complications	Complications arising during surgery (perforation, cervical laceration, excess bleeding)	intraoperative