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Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion (MisoWet)

Primary Purpose

Abortion Early

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
dry misoprostol
wet misoprostol
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion Early focused on measuring misoprostol, abortion

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with abortion (less than 12 weeks of pregnancy)

Exclusion Criteria:

  • congestive heart failure
  • chronic pulmonary disease
  • hypovolemic shock
  • twins
  • Marfan syndrome
  • septic abortion (fever, pus , leukocytosis >14,000)
  • known allergies to misoprostol
  • blood dyscrasia
  • open cervical (≥ 1cm)
  • use of intrauterine device

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dry Misoprostol

Wet misoprostol

Arm Description

400 µg of dry misoprostol

400 µg of wet misoprostol

Outcomes

Primary Outcome Measures

Cervical dilation
Cervical dilation will be measure with Karman cannulas

Secondary Outcome Measures

Vaginal acidity - hydrogen ion concentration
at the moment of the introduction of misoprostol into the vagina

Full Information

First Posted
August 4, 2015
Last Updated
March 24, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02522078
Brief Title
Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion
Acronym
MisoWet
Official Title
Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Detailed Description
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion Early
Keywords
misoprostol, abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Misoprostol
Arm Type
Active Comparator
Arm Description
400 µg of dry misoprostol
Arm Title
Wet misoprostol
Arm Type
Experimental
Arm Description
400 µg of wet misoprostol
Intervention Type
Drug
Intervention Name(s)
dry misoprostol
Intervention Description
400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
Intervention Type
Drug
Intervention Name(s)
wet misoprostol
Intervention Description
400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
Primary Outcome Measure Information:
Title
Cervical dilation
Description
Cervical dilation will be measure with Karman cannulas
Time Frame
3 to 4 hours after putting misoprostol into the vagina
Secondary Outcome Measure Information:
Title
Vaginal acidity - hydrogen ion concentration
Description
at the moment of the introduction of misoprostol into the vagina
Time Frame
within 2 min before putting the misoprostol into the vagina

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with abortion (less than 12 weeks of pregnancy) Exclusion Criteria: congestive heart failure chronic pulmonary disease hypovolemic shock twins Marfan syndrome septic abortion (fever, pus , leukocytosis >14,000) known allergies to misoprostol blood dyscrasia open cervical (≥ 1cm) use of intrauterine device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F Savaris, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
WHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993
Results Reference
background
PubMed Identifier
11023804
Citation
Regan L, Rai R. Epidemiology and the medical causes of miscarriage. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Oct;14(5):839-54. doi: 10.1053/beog.2000.0123.
Results Reference
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PubMed Identifier
17126724
Citation
Grimes DA, Benson J, Singh S, Romero M, Ganatra B, Okonofua FE, Shah IH. Unsafe abortion: the preventable pandemic. Lancet. 2006 Nov 25;368(9550):1908-19. doi: 10.1016/S0140-6736(06)69481-6.
Results Reference
background
PubMed Identifier
16581405
Citation
Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
Results Reference
background
PubMed Identifier
23543549
Citation
Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007223. doi: 10.1002/14651858.CD007223.pub3.
Results Reference
background
PubMed Identifier
9609268
Citation
Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol. 1998 Apr;105(4):413-7. doi: 10.1111/j.1471-0528.1998.tb10126.x.
Results Reference
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Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

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