NCT02522078

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

August 4, 2015

Last Update Submit

March 24, 2016

Conditions

Abortion Early

Keywords

misoprostolabortion

Outcome Measures

Primary Outcomes (1)

  • Cervical dilation

    Cervical dilation will be measure with Karman cannulas

    3 to 4 hours after putting misoprostol into the vagina

Secondary Outcomes (1)

  • Vaginal acidity - hydrogen ion concentration

    within 2 min before putting the misoprostol into the vagina

Study Arms (2)

Dry Misoprostol

ACTIVE COMPARATOR

400 µg of dry misoprostol

Drug: dry misoprostol

Wet misoprostol

EXPERIMENTAL

400 µg of wet misoprostol

Drug: wet misoprostol

Interventions

dry misoprostolDRUG

400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

Dry Misoprostol
wet misoprostolDRUG

400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

Wet misoprostol

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (6)

  • WHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993

    BACKGROUND

  • 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.

    PMID: 11023804BACKGROUND

  • 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.

    PMID: 17126724BACKGROUND

  • 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.

    PMID: 16581405BACKGROUND

  • 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.

    PMID: 23543549BACKGROUND

  • 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.

    PMID: 9609268BACKGROUND

Study Officials

  • Ricardo F Savaris, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

BR(1)