Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

Miscarriage in First Trimester Clinical Trial

— MISO200  

Official title:

Comparison Between 400 µg or 200 µg of Misoprostol for Cervical Dilatation in 1st Trimester Miscarriage - A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957305
• Other study ID #: 160309
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Description:

Miscarriage is defined by the World Health Organization as the interruption of the pregnancy up to 20-23 weeks, or the products of pregnancy weighing less than 500 grams (1). Nearly 15% of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the major cause of maternal death, particularly in Latin America and the Caribbean. In cases of retained and incomplete abortions, uterine emptying is recommended. In the first trimester of pregnancy, either pharmacological or surgical procedure is accepted according to international guidelines.

Pharmacological treatment for uterine evacuation includes the administration of mifepristone and misoprostol or misoprostol alone. Nevertheless, surgical methods have been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.

MVA should be performed after cervical ripening. This pre-surgical procedure makes the procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be used in these cases because of its efficacy, ease of use, low cost, stability at room temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be administered by oral, sublingual, buccal, rectal, and vaginal routes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 30, 2020
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de Porto Alegre scheduled for uterine evacuation with <12 weeks of gestation.

Exclusion Criteria:

• patients who do not wish to participate in the project;

• patients with ectopic pregnancy;

• patients with comorbidities (heart failure congestive, chronic obstructive pulmonary disease);

• patients with hypovolemic shock;

• patients with cervical incompetence;

• patients with infected miscarriage/abortion (presence of fever, pus from the cervix, leukocytosis [> 14000]);

• patients with twin pregnancy;

• patients with Marfan syndrome;

• patients allergic to misoprostol;

• patients with coagulopathy;

• patients with opening of cervical internal os (4 mm of dilatation at the time of consultation);

• patients with previous surgery of the cervix (conization);

• patients with concomitant use of IUDs.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage in First Trimester

Intervention

Drug:
• Misoprostol 400mcg Tab
400µg of misoprostol (2 tablets)
• Misoprostol 200mcg Tab
200µg of misoprostol (1 tablet)

Locations

Country	Name	City	State
Brazil	HCPA	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

ACOG Committee Opinion. American College of Obstetrician and Gynecologist. ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Obstet Gynecol. 2003 May;101(5 Pt 1):1049-50. — View Citation

Blanchard K, Clark S, Winikoff B, Gaines G, Kabani G, Shannon C. Misoprostol for women's health: a review. Obstet Gynecol. 2002 Feb;99(2):316-32. Review. — View Citation

Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007207. doi: 10.1002/14651858.CD007207.pub2. Review. — View Citation

Marret H, Simon E, Beucher G, Dreyfus M, Gaudineau A, Vayssière C, Lesavre M, Pluchon M, Winer N, Fernandez H, Aubert J, Bejan-Angoulvant T, Jonville-Bera AP, Clouqueur E, Houfflin-Debarge V, Garrigue A, Pierre F; Collège national des gynécologues obstétriciens français. Overview and expert assessment of off-label use of misoprostol in obstetrics and gynaecology: review and report by the Collège national des gynécologues obstétriciens français. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:80-4. doi: 10.1016/j.ejogrb.2015.01.018. Epub 2015 Jan 31. Review. — View Citation

National Collaborating Centre for Women's and Children's Health (UK). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: RCOG; 2012 Dec. — View Citation

Tang J, Kapp N, Dragoman M, de Souza JP. WHO recommendations for misoprostol use for obstetric and gynecologic indications. Int J Gynaecol Obstet. 2013 May;121(2):186-9. doi: 10.1016/j.ijgo.2012.12.009. Epub 2013 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Score (VAS)	Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain)	before Manual Vacuum Aspiration
Primary	Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration	this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration	baseline at initiation of the Manual Vacuum Aspiration
Secondary	Number of Participants With a Presence of a Uterine Cervical Canal With =8 mm of Dilation	This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (=8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter.	Baseline before Manual Vacuum Aspiration procedure