Different Routes of Misoprostol Prior to First Trimester Surgical Abortion
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedApril 29, 2016
April 1, 2016
1 year
June 20, 2015
April 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Time required to achieve cervical dilatation
intraoperative
Ease of cervical dilatation
intraoperative
Patient preference
baseline
Adverse effects of medication
baseline
Surgical complications
intraoperative
Study Arms (3)
PO Misoprostol
ACTIVE COMPARATORCervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage
PV Misoprostol
ACTIVE COMPARATORCervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage
Buccal Misoprostol
ACTIVE COMPARATORCervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage
Interventions
Eligibility Criteria
You may qualify if:
- Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age \<13+0 weeks
- Written consent supplied
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edith Wolfson Medical Center
Holon, Israel
Related Publications (1)
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PMID: 34061352DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadas Ganer Herman, MD
Edith Wolfson Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 20, 2015
First Posted
June 24, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
April 29, 2016
Record last verified: 2016-04