Clinical trial NCT02522078: Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion
Official title: Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion Early
Keywords: misoprostol
abortion
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 46
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cervical dilation
timeFrame: 3 to 4 hours after putting misoprostol into the vagina
Secondary outcomes:
measure: Vaginal acidity - hydrogen ion concentration
timeFrame: within 2 min before putting the misoprostol into the vagina
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo F Savaris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: WHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993
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.
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.
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.
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.
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.