Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Phase 4

• Conditions: Abortion, Induced
• Interventions: Drug: Misoprostol (cytotec)

• Registration Number: NCT02480543
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-20
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Study Start: 2015-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buccal Misoprostol	Misoprostol (cytotec)	Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage
PV Misoprostol	Misoprostol (cytotec)	Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage
PO Misoprostol	Misoprostol (cytotec)	Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage

Primary Outcome Measures

Name	Time	Method
Preoperative cervical width in centimeters	intraoperative	• 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.

Secondary Outcome Measures

Name	Time	Method
Patient preference	baseline	Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Adverse effects of medication	baseline	Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
Time required to achieve cervical dilatation	intraoperative	The time in minutes required for dilatation up to a number 10 Hegar
Ease of cervical dilatation	intraoperative	The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy
Surgical complications	intraoperative	Complications arising during surgery (perforation, cervical laceration, excess bleeding)

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel