Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

Abortion Early Clinical Trial

— MisoWet  

Official title:

Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522078
• Other study ID #: 15-0115
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2015
• Last updated: March 24, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion Early

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. Review. — View Citation

Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-74. Review. — View 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. Review. — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical dilation	Cervical dilation will be measure with Karman cannulas	3 to 4 hours after putting misoprostol into the vagina	No
Secondary	Vaginal acidity - hydrogen ion concentration	at the moment of the introduction of misoprostol into the vagina	within 2 min before putting the misoprostol into the vagina	No