Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

NCT ID: NCT02522078

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

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.

Conditions

Abortion Early

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dry Misoprostol

400 µg of dry misoprostol

Group Type: ACTIVE_COMPARATOR

dry misoprostol

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

wet misoprostol

Intervention Type: DRUG

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

Interventions

dry misoprostol

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

Intervention Type: DRUG

wet misoprostol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo F Savaris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11023804 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17126724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16581405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23543549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9609268 (View on PubMed)

Other Identifiers

15-0115

Identifier Type: -

Identifier Source: org_study_id