Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 4

Conditions: Abortion, Induced

Treatments: Drug: Misoprostol (cytotec)

Study type: Interventional

Funder types: Other

Identifiers

NCT02480543

0085-15-WOMC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

PO Misoprostol

Active Comparator group

Description:

Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage

Treatment:

Drug: Misoprostol (cytotec)

PV Misoprostol

Active Comparator group

Description:

Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage

Treatment:

Drug: Misoprostol (cytotec)

Buccal Misoprostol

Active Comparator group

Description:

Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage

Treatment:

Drug: Misoprostol (cytotec)