Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Study Overview
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Brief Summary
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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.

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

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Misoprostol (cytotec)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PO Misoprostol<br>Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage | Drug: Misoprostol (cytotec)<br> <br> |
| Active Comparator: PV Misoprostol<br>Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage | Drug: Misoprostol (cytotec)<br> <br> |
| Active Comparator: Buccal Misoprostol<br>Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage | Drug: Misoprostol (cytotec)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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